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Medical advancements and improvements in how doctors treat disease are made possible by what we learn through clinical trials. Commonly done in a medical setting such as a hospital, clinical trials are research studies that evaluate the safety and effectiveness of new treatments, whether they are drugs, devices, or preventative and other therapeutic measures that can influence health. Patients who participate in clinical trials have the opportunity to access treatments before they are publically available and also help others by contributing to medical research.  

Atlantic Health System hospitals participate in numerous clinical trials in partnership with other research organizations and pharmaceutical or biotech sponsors. Please browse the listing of clinical trials below to learn more about our open and active studies. Our physicians are committed to finding the latest treatments within a variety of medical areas, with a particular focus on cancer, genetics and congenital disease, movement disorders such as Parkinson’s disease, pediatrics, valve disease, and women’s health. 

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Acne
Open to Enrollment

A Phase 3 Multi-Center, Randomized, Dboule-Blinded, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy, Tolerability and Safety of Once Daily SB204 and Vehicle Gel in the Treatment of Acne Vulgaris

This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.

Investigator:
Hilary Baldwin
NI-AC302 | PHASE III

Sponsor:
Novan, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 9 Years to 99 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Moderate to severe acne
• Minimum of 25 and no more than 70 non-inflammatory lesions (open and closed comedones) on the face
• Minimum of 20 and no more than 40 inflammatory lesions (papules and pustules)

Exclusion Criteria:
• Women of child-bearing potential who are pregnant, nursing, considering becoming pregnant
• Any dermatologic condition that could interfere with clinical evaluations including severe, recalcitrant cystic acne

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908-522-6156
research@atlantichealth.org

More info:
ClinicalTrials.gov

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Acne
Open to Enrollment

A Randomized, Double-blind, Vehicle Controlled, Efficacy and Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil Gel compared to vehicle in patients with acne vulgaris.

Investigator:
Hilary Baldwin, MD
DRM01B-ACN03 | PHASE III

Sponsor:
Dermira, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 9 Years and older (Child, Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Signed informed consent and, for subjects under legal adult age, signed assent
• Age ≥ 9 years
• Clinical diagnosis of facial acne vulgaris defined as:
◦At least 20 inflammatory lesions, and
◦At least 20 non-inflammatory lesions, and
◦Investigator Global Assessment of 3 or greater

Exclusion Criteria:
• Active cystic acne or acne conglobata, acne fulminans, and secondary acne
• Two or more active nodulocystic lesions on the face
• Clinically significant abnormal laboratory or ECG result
• Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days or 5 half-lives (whichever is longer) of the Baseline visit
• Treatment with over-the-counter topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, α-hydroxy/glycolic acid on the face within 2 weeks prior to Baseline
• Treatment with systemic antibiotics or systemic anti-acne drugs or topical retinoid within 4 weeks prior to Baseline
• Treatment with a new hormonal therapy or dose change to existing hormonal therapy within 12 weeks prior to Baseline (hormonal therapies include, but are not limited to, estrogenic and progestational agents such as birth control pills).
• Use of androgen receptor blockers (such as spironolactone or flutamide) within 2 weeks prior to Baseline.
• Oral retinoid use (e.g., isotretinoin) within 12 months prior to Baseline or vitamin A supplements greater than 10,000 units/day within 6 months prior to Baseline
• Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8 weeks

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Contact:
973-630-2200
research@atlantichealth.org

More info:
ClinicalTrials.gov

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Acne
Open to Enrollment

An Open-Label Study Assessing Long-Term Safety of Olumacostat Glasaretil Gel in Subjects with Acne Vulgaris

The objectives of this study are to assess the long-term safety of Olumacostat Glasaretil gel, 5.0% in patients with acne vulgaris.

Investigator:
Hilary Baldwin, MD
DRM01B-ACN05 | PHASE III

Sponsor:
Dermira, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 9 Years and older (Child, Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Signed informed consent or assent (for subjects under legal adult age)
• Completed Week 12 visit of either DRM01B-ACN03 or DRM01B-ACN04 studies.
• Willing to comply with the protocol. Subjects under legal adult age will be assessed by the investigator as to their ability to comply with the protocol
• Willing to refrain from using any treatments on the face for acne vulgaris, other than the investigational product, including topical or systemic antibiotics.

Exclusion Criteria:
• Abnormal clinically significant findings on physical exam, vital signs or ECG at Week 12 visit of either the DRM01-ACN03 or DMR01-ACN04 studies that would make further treatment with Olumacostat Glasaretil Gel contraindicated, as determined by the Investigator
• Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study

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Contact:
973-630-2200
research@atlantichealth.org

More info:
ClinicalTrials.gov

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Acne
Open to Enrollment

Efficacy and Safety of Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel Plus Doxycycline in Severe Inflammatory Acne (Non-Nodulocystic) Subjects

Demonstrate that a daily treatment regimen of adapalene 0.3%/benzoyl peroxide 2.5% gel + oral Doxycycline 200 mg is effective and safe in severe inflammatory acne with 3 or fewer nodules or cysts (non-nodulocystic) during a 12-week treatment period.

Investigator:
Hilary Baldwin, MD
ALAMO | PHASE IV

Sponsor:
Galderma Laboratories, L.P.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 12 Years and older (Child, Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Key Inclusion Criteria:
1. Male or female subjects, 12 years of age or older at Screening visit.
2. Subjects with a clinical diagnosis of severe inflammatory acne (IGA score of 4).
3. Subjects with 2 or fewer nodules on the face, less than 1 cm in diameter.
4. Subjects 18 years of age or older must read and sign the Informed Consent Form, which includes Photography Consent and HIPAA authorization, prior to any participation in the study. Consent will be obtained prior to any study-related procedures. Subjects under the age of 18 years must sign an Assent to Participate Form to participate in the study and must have one parent or guardian read and sign the Informed Consent Form prior to any study-related procedure. (The parent or guardian is not required to attend the following visits unless requested.)

Key Exclusion Criteria:
1. Subjects with nodulocystic or conglobate acne, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.).
2. Subjects with 3 or more acne nodules or cysts on the face at Screening and Baseline visits.
3. Female subjects who are pregnant, nursing, or planning a pregnancy during the study.
4. Subjects who have used any systemic therapy directed at improving acne, including antibiotics, within 30 days prior to Baseline visit.
5. Subjects who are at risk in terms of precautions, warnings, and contraindications for the investigational study drugs (see Appendix 14.1 for package inserts for adapalene 0.3%/benzoyl peroxide 2.5% gel and doxycycline hyclate Tablets).
6. Subjects with any other condition or circumstance which, in the Investigator's opinion, may put the subject at risk (e.g., a history of significant renal disease with impairment of renal function), confound the study results, or interfere with the subject's participation in the study.
7. Sponsor and study site staff, relatives of staff members, or other individuals who would have access to the clinical study protocol.

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973-630-2200
research@atlantichealth.org

More info:
ClinicalTrials.gov

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Aortic Stenosis
Open to Enrollment

A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Requiring Aortic Valve Replacement Who Have Severe, Calcific, Symptomatic Aortic Stenosis

To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve in patients with severe, symptomatic aortic stenosis who are at low operative risk for standard aortic valve replacement (AVR).

Investigator:
John Brown, MD
Partner 3 | PHASE III

Sponsor:
Edwards Lifesciences LLC

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 65 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. 65 years of age or older at time of consent.
2. Symptomatic, severe, calcific aortic stenosis with the following TTE criteria:
◦Jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg AND
◦AVA ≤ 1.0 cm2 or AVA index ≤ 0.6 cm2/m2
3. Aortic valve annulus 273 mm2 - 683 mm2 measured by 3D imaging (CT, TEE or MRI)
4. Adequate iliofemoral access with minimum average vessel diameter of 5.5mm (20, 23, 26mm) and 6.0mm (29mm) and acceptable level of vessel calcification and tortuosity for safe device implant
5. NYHA Functional Class ≥ II
6. Heart team agrees the patient has a risk of operative mortality < 2% (e.g., STS <4).
7. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.

Exclusion Criteria:
1. ≥ 1/4 frailty. (Only 0/4 frail patients may be enrolled in the trial).
2. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization with evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. Any one of the following criteria meets the diagnosis for MI:
◦Detection of a rise and/or fall of cardiac biomarker values (preferably cardiac troponin (cTn)) with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following:
◦Symptoms of ischemia
◦New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB)
◦Development of pathological Q waves in the ECG
◦Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality
◦Identification of an intracoronary thrombus by angiography
3. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified
4. Severe aortic regurgitation (>3+)
5. Severe mitral regurgitation (>3+)
6. Pre-existing mechanical or bioprosthetic valve in any position. (Of note, mitral ring is not an exclusion).
7. Any patient with a balloon valvuloplasty (BAV) within 30 days of the valve implant procedure (unless BAV is a bridge to procedure after a qualifying ECHO).
8. Any therapeutic invasive cardiac procedure performed within 30 days of the valve implant procedure. Pre-planned PCI performed within 2 weeks prior to valve procedure or implantation of a permanent pacemaker or Implantable Cardioverter Defibrillator (ICD) is not considered exclusionary criteria.
9. Complex coronary artery disease:
◦Unprotected left main coronary artery
◦Syntax score > 32 (in the absence of prior revascularization)
10. Non-complex, flow limiting coronary artery disease requiring revascularization that cannot be treated at the time of or within 2 weeks prior to the valve procedure.
11. Patients with a planned concomitant surgical or transcatheter ablation for atrial fibrillation.
12. Leukopenia (WBC < 3000 cell/mL), anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt < 50,000 cell/mL)
13. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the screening visit.
14. Emergency interventional/surgical procedures within 30 days of the valve implant procedure
15. Any planned surgical or peripheral procedure to be performed within the 30 day follow-up from the valve implant procedure
16. Hypertrophic cardiomyopathy with or without obstruction (HOCM)
17. Ventricular dysfunction with LVEF < 45%
18. Cardiac imaging (echo, CT, and/or MRI) evidence of intracardiac mass, thrombus or vegetation
19. History of upper GI bleeding within 90 days of the valve implant procedure
20. Inability to tolerate anti-thrombotic/anticoagulation therapy during or after the valve implant procedure
21. Stroke or transient ischemic attack (TIA) within 180 days of the valve implant procedure
22. Renal insufficiency (eGFR < 40 ml/min per the Cock-croft-Gault formula) and/or renal replacement therapy at the time of screening
23. Active bacterial endocarditis within 180 days of the valve implant procedure
24. Severe lung disease (FEV1 < 50% predicted) or currently on home oxygen
25. Chronic liver disease (MELD Score ≥ 10 or Child-Pugh Class B or C)
26. Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma [especially if thick (>5mm), protruding or ulcerated] or narrowing (especially with calcification and surface irregularities) of the abdominal thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta.
27. Porcelain aorta
28. Complications with prior cardiac surgery (i.e., mediastinitis, prolonged intubation)
29. Patient refuses blood products
30. Severe chest deformity (i.e., pectus excavatum, mastectomy, iatrogenic radiation exposure)
31. BMI > 50 kg/m2
32. Estimated life expectancy < 24 months
33. Known blood dyscrasia
34. Aortic coarctation
35. Absolute contraindications or allergy to iodinated contrast that cannot be pre-medicated
36. Immobility that would prevent completion of study procedures
37. Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. Observational studies are not considered exclusionary.
38. Patient refuses SAVR

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Contact:
973-971-4099
research@atlantichealth.org

More info:
ClinicalTrials.gov

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Aortic Stenosis
Open to Enrollment

A Randomized Evaluation of the TriGuard Embolic Deflection Device to Reduce the Impact of Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation

The Keystone Heart TriGuard™ device is an aortic embolism deflection device intended to reduce the amount of embolic material that may enter the carotid, subclavian, and vertebral arteries during transcatheter heart valve implantation. The objective of the...

Investigator:
Robert Kipperman, MD

study is to assess the safety and efficacy of the TriGuard™ embolic deflection device in patients undergoing transcatheter aortic valve implantation (TAVI), in comparison with an active control group of patients undergoing unprotected transcatheter aortic valve implantation (TAVI).

REFLECT | PHASE II/III

Sponsor:
Keystone Heart Ltd.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. The patient is a male or non-pregnant female ≥18 years of age
2. The patient meets indications for transcatheter aortic valve implantation (TAVI)
3. The patient is willing to comply with protocol-specified follow-up evaluations
4. The patient, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC).

Exclusion Criteria:
1. Patients undergoing transcatheter aortic valve implantation (TAVI) via the trans-axillary, trans-subclavian, or trans-aortic route
2. Patients undergoing transcatheter aortic valve implantation (TAVI) via the transapical approach due to friable or mobile atherosclerotic plaque in the aortic arch
3. Patients with a previously implanted prosthetic aortic valve (i.e., planned valve-in-valve transcatheter aortic valve implantation (TAVI))
4. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 14 days prior to index procedure per site standard test.
5. Patients with known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure (according to definition) or AMI >72 hours preceding the index procedure, in whom Creatine Kinase (CK) and CK-MB have not returned to within normal limits at the time of procedure, or patients who are currently experiencing clinical symptoms consistent with new-onset AMI, such as nitrate-unresponsive prolonged chest pain.
6. Patients with a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, patients who will refuse transfusion, or patients with an active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the prior 6 months
7. Patients with known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than one year.
8. Patients with severe allergy or known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel, nitinol, stainless steel alloy, and/or contrast sensitivity that cannot be adequately pre-medicated.
9. Patients with a history of a stroke or transient ischemic attack (TIA) within the prior 12 months.
10. Patients with renal failure (estimated Glomerular Filtration Rate [eGFR] <30 mL/min, calculated from serum creatinine by the Cockcroft-Gault formula)
11. Patients with hepatic failure (Child-Pugh class C)
12. Patients with hypercoagulable states that cannot be corrected by additional periprocedural heparin
13. Patients presenting with cardiogenic shock at the time of the index procedure.
14. Patients with severe peripheral arterial disease that precludes delivery sheath vascular access
15. Patients in whom the aortic arch, innominate artery ostium, or proximal innominate artery is heavily calcified, severely atheromatous, or severely tortuous.
16. Patients with any other condition that would prevent adherence to the TriGuard HDH Instructions for Use.
17. Patients with contraindication to cerebral magnetic resonance imaging (MRI).
18. Patients who have a planned treatment with any other investigational device or procedure during the study period.
19. Patients planned to undergo any other cardiac surgical or interventional procedure (e.g., concurrent coronary revascularization) during the transcatheter aortic valve implantation (TAVI) procedure or within 10 days prior to the transcatheter aortic valve implantation (TAVI) procedure. NOTE: Diagnostic cardiac catheterization is permitted within 10 days prior to the transcatheter aortic valve implantation (TAVI) procedure.

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Contact:
973-971-7541
research@atlantichealth.org

More info:
ClinicalTrials.gov

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Aortic Stenosis
Open to Enrollment

Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis

This clinical trial is a prospective, randomized, controlled, multi-center study. Patients will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 THV or clinical surveillance. Patients will be stratified...

Investigator:
Philippe Genereux, MD

by whether or not they are able to perform a treadmill stress test. Patients who have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.

EARLY-TAVR | PHASE III

Sponsor:
Edwards Lifesciences LLC

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 65 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Severe aortic stenosis
2. Patient is asymptomatic
3. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the institutional review board of the respective clinical site.

Exclusion Criteria:
1. Patient is symptomatic.
2. Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
3. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
4. Aortic valve is a unicuspid, bicuspid, or is non-calcified.
5. Severe aortic regurgitation (>3+).
6. Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis.

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Contact:
973-971-4205
research@atlantichealth.org

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ClinicalTrials.gov

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Aortic Stenosis
Closed to Enrollment

Medtronic CoreValve US Expanded Use Study

The primary objective of the study is to evaluate the safety and effectiveness of the Medtronic CoreValve® System (MCS) in a subset of subjects excluded from the U.S. Extreme Risk Pivotal Trial population due to one or more additional co-morbidities, as measured...

Investigator:
John Brown, MD

by a composite of all-cause death or major stroke at 12 months, in the treatment of symptomatic severe aortic stenosis in subjects necessitating aortic valve replacement. Subjects enrolled in this study have a predicted operative mortality or serious, irreversible morbidity risk of =50% at 30 days associated with surgical aortic valve replacement.

Expanded Use

Sponsor:
Medtronic, Inc.

Inclusion & Exclusion Criteria:
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Probability Sample

Study Population

Subjects with symptomatic severe aortic stenosis requiring aortic valve replacement, with predicted operative mortality or serious, irreversible morbidity risk of ≥ 50% at 30 days, and at least one of the following conditions:
•Severe (≥3-4+) mitral valve regurgitation
•Severe (≥3-4+) tricuspid valve regurgitation
•End stage renal disease (ESRD) requiring renal replacement therapy
•Low gradient, low output aortic stenosis
•Failed bioprosthetic surgical aortic valve
•2 or more conditions (listed above)

Criteria

Inclusion Criteria:
•Subject must have co-morbidities such that one cardiologist and two cardiac surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious morbidity exceeds the probability of meaningful improvement. Specifically, the predicted operative risk of death or serious, irreversible morbidity is ≥ 50% at 30 days.
•Subjects must meet all of the criteria under at least one of the sub-groups 2a-c:
a. Senile degenerative aortic valve stenosis and i. At least one of the following co-morbid conditions:
a. Severe (≥3-4+) mitral valve regurgitation as measured by echocardiography
b. Severe (≥3-4+) tricuspid valve regurgitation as measured by echocardiography
c. End-stage renal disease requiring renal replacement therapy (Stage 5 of the KDOQI CKD Classification)
AND
ii. mean gradient > 40 mmHg or jet velocity greater than 4.0 m/sec by either resting or dobutamine stress echocardiogram (if the LVEF < 50%), or simultaneous pressure recordings at cardiac catheterization either resting or with dobutamine stress (if the LVEF < 50%), AND iii. an initial aortic valve area of ≤ 0.8 cm2 (or aortic valve area index ≤0.5 cm2/m2) by resting echocardiogram or simultaneous pressure recordings at cardiac catheterization
AND/OR
b. Low gradient, low output aortic stenosis as defined by the presence of all three of the following i. In the presence of LVEF <50%, absence of contractile reserve, a mean gradient <40mmHg AND jet velocity less than 4.0m/sec with dobutamine stress echocardiography or simultaneous pressure recordings at cardiac catheterization OR In the presence of LVEF ≥50%, a mean gradient <40mmHg AND jet velocity less than 4.0 m/sec, by echocardiography or simultaneous pressure recordings at cardiac catheterization ii. an initial aortic valve area of ≤0.8 cm2 (or aortic valve area index ≤0.5 cm2/m2) by resting echocardiogram or simultaneous pressure recordings at cardiac catheterization AND iii. radiographic evidence of severe aortic valve calcification c. Failed bioprosthetic surgical aortic valve

•Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater.
•The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the IRB of the respective clinical site.
•The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Exclusion Criteria:

Clinical
•Evidence of an acute myocardial infarction ≤30 days before the MCS TAVI procedure.
•Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the MCS TAVI procedure
•Blood dyscrasias as defined: leukopenia (WBC <1000mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy.
•Untreated clinically significant coronary artery disease requiring revascularization.
•Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
•Need for emergency surgery for any reason.
•Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram.
•Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
•Active Gastrointestinal (GI) bleeding within the past 3 months.
•Hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, warfarin, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated.
•Ongoing sepsis, including active endocarditis.
•Subject refuses a blood transfusion.
•Life expectancy <12 months due to associated non-cardiac co-morbid conditions.
•Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.
•Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
•Currently participating in an investigational drug or another device study.
•Symptomatic carotid or vertebral artery disease.

Anatomical
•Native aortic annulus size <18 mm or >29 mm per the baseline diagnostic imaging.
•Pre-existing prosthetic heart valve in the any position
•Moderate to severe mitral stenosis.
•Mixed aortic valve disease: aortic stenosis and aortic regurgitation with predominant aortic regurgitation, (AR is moderate-severe to severe (≥3-4+))(except for failed surgical bioprothesis)
•Hypertrophic obstructive cardiomyopathy.
•Echocardiographic evidence of new or untreated intracardiac mass, thrombus or vegetation.
•Severe basal septal hypertrophy with an outflow gradient.
•Aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) >70° (for femoral and left subclavian/axillary access) and >30° (for right subclavian/axillary access).
•Ascending aorta that exceeds the maximum diameter for any given native aortic annulus size (see table below) Aortic Annulus Diameter Ascending Aorta Diameter 18 mm - 20 mm >34 mm 20 mm - 23 mm >40 mm 23 mm - 27 mm >43 mm 27 mm - 29 mm >43 mm
•Congenital bicuspid or unicuspid valve verified by echocardiography.
•Sinus of valsalva anatomy that would prevent adequate coronary perfusion.
•Degenerated surgical bioprothesis presents with a significant concomitant perivalvular leak (between prothesis and native annulus), is not securely fixed in the native annulus, or is not structurally intact (e.g. wireform frame fracture) (ONLY FOR TAV in SAV subjects)
•Degenerated surgical bioprothesis presents with a partially detached leaflet that in the aortic position may obstruct a coronary ostium (ONLY FOR TAV in SAV subjects)

Vascular
•Transarterial access not able to accommodate an 18Fr sheath.

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More info:
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Aortic Stenosis
Closed to Enrollment

SALUS Trial TranScatheter Aortic Valve RepLacement System Pivotal Trial The Safety and Effectiveness of the Direct Flow Medical Tanscatheter Aortic Valve System

Prospective, randomized, unblended, multi-center investigational study with enrollment at up to 45 Investigational sites. The study is designed to compare the study device (Direct Flow Medical Transcatheter Aortic Valve System) composite event rate to a comparator...

Investigator:
Robert Kipperman, MD

(Medtronic CoreValve commercially available) in high and extreme risk subjects with severe symptomatic aortic stenosis.

SALUS

Sponsor:
Direct Flow Medical, Inc.

Inclusion & Exclusion Criteria:
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. The subject has severe senile degenerative aortic valve stenosis etermined by resting or dobutamine stress echocardiogram and Doppler, or simultaneous pressure recordings at cardiac catheterization defined as: mean aortic gradient ≥40 mmHg or peak jet velocity ≥4.0 m/s and an aortic valve area ≤1.0 cm2 or aortic valve area index ≤0.6 cm2/m2.
2. The subject has moderate to severe symptoms from aortic valve stenosis (NYHA Functional Class ≥II)
3. Subject has a documented aortic annulus size of ≥19 mm and <29 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Patient Review Committee [PRC]) and is deemed treatable with an available size of both test and control device..
4. There is agreement by the heart team (which must include a site cardiac interventionalist and two cardiac surgeons that are staff members at the hospital where the procedure is to be performed) that subject is at high operative risk or greater of serious morbidity or mortality with surgical valve replacement (see note below for definitions of extreme and high risk, the required level of surgical assessment, and PRC confirmation) and that TAVR is appropriate. Subjects are judged by a heart team, including two cardiac surgeons, to be at high or greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons operative risk score >8% or at a > 15% risk of mortality at 30 days).This conclusion shall be based on consensus of one cardiac interventionalist and two cardiac surgeons that have examined the subject face to face after careful consideration of the Subject's STS risk score and co-morbidities. NOTE: In the United States, the Centers for Medicare and Medicaid Services (CMS) require independent evaluations by 2 cardiac surgeons for reimbursement.
5. Subject understands the study requirements and the treatment procedures, and provides written informed consent.
6. Subject agrees and is capable of returning to the study hospital for all required scheduled follow up visits.

Exclusion Criteria:
1. Left ventricular ejection fraction (LVEF) <20% determined by resting echocardiogram.
2. Subjects with an acute STEMI within 30 days preceding the index procedure.
3. Chronic kidney disease (creatinine >3.0 mg/dl, renal replacement therapy at the time of screening or unstable renal function).
4. Subjects with a platelet count of <50,000 cells/mm³ or a WBC < 1000 cells/mm³ within 7 days prior to index procedure.
5. Subject has a known contraindication or hypersensitivity to all antithrombin regimens (aspirin, all P2Y12 inhibitors), or inability to be anti-coagulated for the study procedure. Note: Subjects who require chronic anticoagulation must be able to be treated additionally with either aspirin or clopidogrel.
6. Any subject with a balloon valvuloplasty (BAV) within 30 days of the procedure unless the BAV is a bridge to the procedure. The bridge BAV must be performed > 72 hours prior to the index procedure.
7. Subjects who are on a waiting list for any organ transplant.
8. Subjects with known other medical illness associated with a life expectancy of less than one year, or expectation that subject will not improve despite treatment of aortic stenosis.
9. Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to nickel, tantalum, titanium, or polyurethanes
10. Subjects with a history of a stroke or transient ischemic attack TIA) within the prior 6 months of procedure or screening.
11. Subjects with an active gastrointestinal (GI) bleeding (endoscopy proven or bleeding precluding Dual antiplatelet therapy) within the prior 3 months.
12. Subjects presenting with hemodynamic instability or cardiogenic shock requiring inotropic support or mechanical support devices.
13. Subjects who have a planned treatment with any other investigational device or procedure through 1 year follow-up, or who are currently participating in an investigational drug or another device trial.
14. Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TAVR procedure.
15. Untreated clinically significant coronary artery disease requiring revascularization.
16. Trans-esophageal echocardiography (TEE) is contraindicated.
17. Active endocarditis or sepsis within 6 months prior to the study procedure.
18. Any condition resulting in inability to provide informed consent for the trial or difficulty in assessment of neurologic status.Anatomic and Vascular Exclusions
19. Congenital bicuspid or unicuspid valve (except as outlined in the planned nested registry).
20. Prior aortic valve surgery or pre-existing prosthetic heart valve in the mitral or aortic position (mitral and tricuspid rings are permissible).
21. A native valve annulus diameter <19mm or ≥29mm determined by the screening CT scan.
22. Echocardiographic evidence of new intra-cardiac mass untreated thrombus, or vegetation that requires treatment.
23. >3+: aortic regurgitation, mitral regurgitation or tricuspid regurgitation.
24. Severe mitral stenosis.
25. Thoracic aortic aneurysm (TAA) >5.50 cm.

Contact:
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Aortic Stenosis
Open to Enrollment

Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI)

The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve...

Investigator:
John Brown, MD

Replacement (SAVR) or TAVI with the Medtronic CoreValve® System.

SURTAVI

Sponsor:
Medtronic, Inc.

Inclusion & Exclusion Criteria:
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
•Subject must have STS mortality risk score ≥4% and ≤10%;
•Heart Team (consisting of at least one interventional cardiologist and one cardiac surgeon) unanimously agree on indication, treatment proposal, and eligibility for randomization based on their clinical judgment (including anatomy assessment, risk factors, etc.);
•Subject has severe aortic valve stenosis presenting with
a. Critical aortic valve area defined as an initial aortic valve area of ≤1.0 cm2 or aortic valve area index < 0.6 cm2/m2 AND
b. Mean gradient > 40 mmHG or Vmax > 4m/sec by resting echocardiogram [or dobutamine stress echocardiogram if subject has a left ventricular ejection fraction (LEVF) < 55%] or velocity ratio < 0.25;

•Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater;
•Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits;
•Subject meets the legal minimum age to provide informed consent based on local regulatory requirements;

Exclusion Criteria:
•Subject has refused surgical aortic valve replacement (SAVR) as a treatment option;
•Any condition considered a contraindication for placement of a bioprosthetic valve (i.e. subject requires a mechanical valve);
•A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (including inability to be anticoagulated for the index procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated;
•Blood dyscrasias as defined: leukopenia (WBC <1000mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy;
•Ongoing sepsis, including active endocarditis;
•Any condition considered a contraindication to extracorporeal assistance;
•Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to randomization;
•Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of randomization;
•Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support;
•Recent (within 6 months of randomization)cerebrovascular accident (CVA) or transient ischemic attack (TIA);
•Active gastrointestinal (GI) bleeding that would preclude anticoagulation;
•Subject refuses a blood transfusion;
•Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits);
•Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery;
•Estimated life expectancy of less than 24 months due to associated non-cardiac comorbid conditions;
•Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-ups exams;
•Currently participating in an investigational drug or another device trial (excluding registries);
•Evidence of an acute myocardial infarction ≤30 days before the index procedure;
•Need for emergency surgery for any reason;
•True porcelain aorta (i.e. Heart Team agrees the aorta is not clampable for SAVR);
•Extensive mediastinal radiation;
•Liver failure (Child-C);
•Reduced ventricular function with left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram;
•Uncontrolled atrial fibrillation (e.g. resting heart rate > 120 bpm);
•Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements;
•End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min;
•Pulmonary Hypertension (systolic pressure> 80mmHg);
•Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) < 750cc;
•Frailty assessments identify:
a. Subject is < 80 years of age and three or more of the following apply
b. Subject is ≥ 80 years of age and two or more of the following apply
◾Wheelchair bound
◾Resides in an institutional care facility (e.g. nursing home, skilled care center)
◾Body Mass Index < 20 kg/m2
◾Grip Strength < 16 kg
◾Katz Index Score ≤ 4
◾Albumin < 3.5 g/dL
•Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention;

Note: Additional anatomical and vascular exclusion criteria may apply.

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Aortic Stenosis
Open to Enrollment

The Medtronic TAVR 2.0 US Clinical Study

The study objective is to evaluate safety and efficacy of the Medtronic TAVR 2.0 system in patients with severe symptomatic aortic stenosis who are considered at high through extreme risk for surgical aortic valve replacement.

Investigator:
Robert Kipperman, MD
TAVR 2.0

Sponsor:
Medtronic, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: Child, Adult, Senior
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Severe aortic stenosis, defined as aortic valve area of <1.0 cm2 (or aortic valve area index of <0.6 cm2/m2) by the continuity equation, AND mean gradient >40 mmHg OR maximal aortic valve velocity >4.0 m/sec by resting echocardiogram
2. STS score of ≥8 OR documented heart team agreement of ≥ high risk for AVR due to frailty or co-morbidities
3. Symptoms of aortic stenosis AND NYHA Functional Class II or greater
4. The subject and the treating physician agree that the subject will return for all required post procedure follow-up visits.

Exclusion Criteria:
1. Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve)
2. A known hypersensitivity or contraindication to any of the following which cannot be adequately pre medicated:
◦aspirin or heparin (HIT/HITTS) and bivalirudin
◦ticlopidine and clopidogrel
◦nitinol (titanium or nickel)
◦contrast media
3. Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
4. Untreated clinically significant coronary artery disease requiring revascularization
5. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% by echocardiography, contrast ventriculography, or radionuclide ventriculography
6. End stage renal disease requiring chronic dialysis or creatinine clearance <20 cc/min.
7. Ongoing sepsis, including active endocarditis
8. Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to study procedure
9. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment
10. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
11. Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
12. Gastrointestinal (GI) bleeding that would preclude anticoagulation
13. Subject refuses a blood transfusion
14. Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)
15. Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions
16. Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams
17. Currently participating in an investigational drug or another device study (excluding registries)
18. Evidence of an acute myocardial infarction ≤30 days before the study procedure
19. Need for emergency surgery for any reason
20. Liver failure (Child-Pugh class C)
21. Subject is pregnant or breast feeding
22. Pre existing prosthetic heart valve in any position
23. Mixed aortic valve disease (aortic stenosis with severe aortic regurgitation)
24. Severe mitral regurgitation
25. Severe tricuspid regurgitation
26. Moderate or severe mitral stenosis
27. Hypertrophic obstructive cardiomyopathy
28. Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac mass, thrombus, or vegetation
29. Congenital bicuspid or unicuspid valve verified by echocardiography
30. Access vessel diameter <5.5 mm or <6.0 mm for patent LIMA

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Aortic Stenosis
Closed to Enrollment

Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Randomized Clinical Evaluation

The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high...

Investigator:
Barry Cohen, MD

risk for surgical valve replacement.

REPRISE III

Sponsor:
Boston Scientific Corporation

Inclusion & Exclusion Criteria:
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Subject has documented calcific, severe native aortic stenosis with an initial aortic valve area (AVA) of ≤1.0 cm2 (or AVA index of ≤0.6 cm2/m2) and a mean pressure gradient ≥40 mm Hg or jet velocity ≥4.0 m/s, as measured by echocardiography and/or invasive hemodynamics
2. Subject has a documented aortic annulus size of ≥20 mm and ≤27 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee [CRC]) and is deemed treatable with an available size of both test and control device
3. Subject has symptomatic aortic valve stenosis with New York Heart Association (NYHA) Functional Class ≥ II
4. There is agreement by the heart team (which must include a site investigator interventionalist and a site investigator cardiac surgeon) that subject is at high or extreme operative risk for surgical valve replacement (see note below for definitions of extreme and high risk, the required level of surgical assessment, and CRC confirmation) and that TAVR is appropriate. Additionally, subject has at least one of the following.
◦Society of Thoracic Surgeons (STS) score ≥8% -OR-
◦If STS <8, subject has at least one of the following conditions: Age ≥ 90, hostile chest, porcelain aorta, severe pulmonary hypertension (>60 mmHg), prior chest radiation therapy, coronary artery bypass graft(s) at risk with re-operation, severe lung disease (need for supplemental oxygen, forced expiratory volume in 1 second [FEV1] <50% of predicted, diffusing capacity of the lungs for carbon monoxide [DLCO] <60%, or other evidence of severe pulmonary dysfunction), neuromuscular disease that creates risk for mechanical ventilation or rehabilitation after surgical aortic valve replacement, orthopedic disease that creates risk for rehabilitation after surgical aortic valve replacement, Childs Class A or B liver disease (subjects with Childs Class C disease are not eligible for inclusion in this trial), frailty as indicated by at least one of the following: 5‑meter walk >6 seconds, Katz Assessment of Daily Living (Katz ADL) score of 3/6 or less, body mass index <21, wheelchair bound, unable to live independently, other evidence that subject is at high or extreme risk for surgical valve replacement (CRC must confirm agreement with site heart team that subject meets high or extreme risk definition)
5. Heart team (which must include a cardiac interventionalist and an experienced cardiac surgeon) assessment that the subject is likely to benefit from valve replacement.
6. Subject (or legal representative) understands the study requirements and the treatment procedures, and provides written informed consent.
7. Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow up visits.

Note: Extreme operative risk and high operative risk are defined as follows: Extreme Operative Risk: Predicted operative mortality or serious, irreversible morbidity risk ≥50% at 30 days; High Operative Risk: Predicted operative mortality or serious, irreversible morbidity risk ≥15% at 30 days. Risk of operative mortality and morbidity must be assessed via an in-person evaluation by a center cardiac surgeon and must be confirmed by the CRC (which must include an experienced cardiac surgeon).

Exclusion Criteria:
1. Subject has a congenital unicuspid or bicuspid aortic valve.
2. Subject has had an acute myocardial infarction (MI) within 30 days prior to the index procedure (defined as Q-wave MI or non-Q-wave MI with total creatine kinase (CK) elevation ≥ twice normal in the presence of creatine kinase-myoglobin band (CK-MB) elevation and/or troponin elevation).
3. Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months prior to study enrollment.
4. Subject has end-stage renal disease or has glomerular filtration rate (GFR) <20 (based on Cockcroft-Gault formula).
5. Subject has a pre-existing prosthetic aortic or mitral valve.
6. Subject has severe (4+) aortic, tricuspid, or mitral regurgitation.
7. Subject has a need for emergency surgery for any reason.
8. Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis.
9. Subject has echocardiographic evidence of new intra-cardiac vegetation or intraventricular or paravalvular thrombus requiring intervention.
10. Subject has (hemoglobin) Hgb <9 g/dL, platelet count <50,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <1,000 cells/mm3.
11. Subject requires chronic anticoagulation therapy after the implant procedure and cannot be treated with warfarin (other anticoagulants are not permitted in the first month) for at least 1 month concomitant with either aspirin or clopidogrel.
12. Subject has active peptic ulcer disease or gastrointestinal bleed requiring hospitalization or transfusion within the past 3 months, or has other clinically significant bleeding diathesis or coagulopathy that would preclude treatment with required antiplatelet regimen, or will refuse transfusions.
13. Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to aspirin, all P2Y12 inhibitors, heparin, nickel, tantalum, titanium, or polyurethanes.
14. Subject has a life expectancy of less than 12 months due to non-cardiac, comorbid conditions based on the assessment of the investigator at the time of enrollment.
15. Subject has hypertrophic obstructive cardiomyopathy.
16. Subject has any therapeutic invasive cardiac or vascular procedure within 30 days prior to the index procedure (except for balloon aortic valvuloplasty or pacemaker implantation, which are allowed).
17. Subject has untreated coronary artery disease, which in the opinion of the treating physician is clinically significant and requires revascularization.
18. Subject has severe left ventricular dysfunction with ejection fraction <20%.
19. Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices.
20. Subject has severe peripheral vascular disease that would preclude safe access (e.g., aneurysm with thrombus that cannot be crossed safely), marked tortuosity, narrowing of the abdominal aorta, severe unfolding of the thoracic aorta, or symptomatic carotid or vertebral disease.
21. Subject has thick (>5 mm) protruding or ulcerated atheroma in the aortic arch
22. Subject has arterial access that is not acceptable for the test and control device delivery systems as defined in the device Instructions For Use.
23. Subject has current problems with substance abuse (e.g., alcohol, etc.).
24. Subject is participating in another investigational drug or device study that has not reached its primary endpoint.
25. Subject has untreated conduction system disorder (e.g., Type II second degree atrioventricular block) that in the opinion of the treating physician is clinically significant and requires a pacemaker implantation. Enrollment is permissible after permanent pacemaker implantation.
26. Subject has severe incapacitating dementia.

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Arrhythmia
Open to Enrollment

Micra Transcatheter Pacing System Continued Access Study

Medtronic is sponsoring the Micra Continued Access (CA) study to provide continued access to the Micra System while the marketing application is under review by the Food and Drug Administration (FDA).

Investigator:
Robert Coyne, MD
Micra CAS | PHASE III

Sponsor:
Medtronic, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
• Subject meets Class I or ll indication for implantation of single chamber ventricular pacemaker and is intended to be implanted with a Micra System
• Subject able and accessible for follow-up per study requirements
• Subject is at least 18 years of age
• Patient is not enrolled in a concurrent drug and/or device study that may confound registry result.

Exclusion Criteria:
• Subject has had an acute myocardial infraction (AMI) within 30 days of implant
• Subject has implantation of neurostimulator or any other chronically implanted device which uses current in the body
• Subject with mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device (LVAD)
• Subjects who are morbidly obese and physician believes telemetry communication of ≤5 inches (12.5 cm) could not be obtained with programmer head.
• Subject who femoral venous anatomy is unable to accommodate a 23 French introducer sheath or implant on the right side of the heart (for example due to obstructions or sever tortuosity) in the opinion of the implanter
• Subjects with known intolerance to Nickel-Titanium (Nitinol) Alloy
• Subject for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated
• Subjects with life expectancy less than 12-months
• Subject is enrolled in a concurrent drug and/or device study that may confound CA study results

Contact:
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research@atlantichealth.org

More info:
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Arrhythmia
Open to Enrollment

Micra™ Transcatheter Pacing Study

The purpose of this clinical study is to evaluate the safety and efficacy of the Micra Transcatheter Pacing System and to assess long term performance.

Investigator:
Robert Coyne, MD
Micra | PHASE III

Sponsor:
Medtronic, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
•Subjects who have a Class I or II indication for implantation of a single chamber ventricular pacemaker according to ACC/AHA/HRS 2008 guidelines and any national guidelines
•Subjects who are able and willing to undergo the study requirements and are expected to be geographically stable for the duration of the follow-up.
•Subjects who are at least 18 years of age (or older, if required by local law).

Exclusion Criteria:
•Subjects who are entirely pacemaker dependent (escape rhythm <30 bpm).
•Subject has an existing or prior pacemaker, ICD or CRT device implant.
•Subject has unstable angina pectoris or has had an acute myocardial infarction (AMI) in the 30 days prior to eligibility assessment.
•Subjects with current implantation of neurostimulator or any other chronically implanted device which uses current in the body. Note that a temporary pacing wire is allowed.
•Subjects with a mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device (LVAD).
•Subjects who are morbidly obese and physician believes telemetry communication of ≤5 inches (12.7 cm) could not be obtained with programmer head.
•Subjects whose femoral venous anatomy is unable to accommodate a 23 French introducer sheath or implant on the right side of the heart (for example, due to obstructions or severe tortuosity) in the opinion of the implanter.
•Subjects who are considered as unable to tolerate an urgent sternotomy
•Subjects with a known intolerance to Nickel-Titanium (Nitinol) Alloy.
•Subjects for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated.
•Subjects with a life expectancy of less than 12- months.
•Subjects who are currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Coenrollment in concurrent trials is only allowed when document pre-approval is obtained from the Medtronic study manager.
•Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control.
•Subjects with exclusion criteria required by local law (e.g. age, breast feeding, etc.).

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Arthritis
Open to Enrollment

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Secukinumab 300 mg and 150 mg in Adult Patients With Active Psoriatic Arthritis After 16 Weeks of Treatment Compared to Placebo and to Assess the Safety, Tolerability and Efficacy up to 52 Weeks

To demonstrate that the efficacy of secukinumab 300 mg at Week 16 is superior to placebo in adult patients with active PsA based on the proportion of patients achieving an American College of Rheumatology 20 (ACR20) response.

Investigator:
Elliot Rosenstein, MD
CAIN457FUS01 | PHASE IV

Sponsor:
Novartis Pharmaceuticals Corporation - NJ

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Male or non-pregnant, non-lactating female patients at least 18 years of age
• Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)
• Rheumatoid factor and anti-CCP antibodies negative
• Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis

Exclusion Criteria:
• Chest X-ray with evidence of ongoing infectious or malignant process
• Patients who ever received biologic immunomodulating agents including those targeting TNFα, IL-6 and IL-12/23 investigational or approved

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Arthritis
Open to Enrollment

Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry

Continuation of the CARRA Registry as described in the protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will...

Investigator:
Sivia Lapidus, MD

be used to answer pressing questions about therapeutics used to treat pediatric rheumatic diseases, including safety questions.

CARRA

Sponsor:
Duke Clinical Research Institute

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 2 Years to 21 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Sampling Method: Non-Probability Sample

Study Population
Children with pediatric rheumatic diseases enrolled from participating CARRA sites.

Inclusion Criteria:
1. Onset of rheumatic disease prior to age 16 years for JIA and onset prior to age 19 years for all other rheumatic diseases (see appendix A).
2. Subject (and/or parent/legal guardian when required) is able to provide written informed consent and willing to comply with study procedures.
3. Subject and/or parent/legal guardian can read either English or Spanish.
4. Subject and/or parent/legal guardian is willing to be contacted in the future by study staff.

Exclusion Criteria:
1. Greater than 21 years of age at the time of enrollment.

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973-971-6308
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Arthritis
Open to Enrollment

Prospective Outcomes Study: Vectra® DA Guided Care Compared to Usual Care

In this 12-month multi-center prospective, site-randomized, two-arm trial, approximately 265 biologic-naïve subjects with RA who are candidates for treatment intensification due to inadequate response to MTX monotherapy will be enrolled at up to 60 study sites.

Investigator:
Elliot Rosenstein, MD

In this 12-month multi-center prospective, site-randomized, two-arm trial, approximately 265 biologic-naïve subjects with RA who are candidates for treatment intensification due to inadequate response to MTX monotherapy will be enrolled at up to 60 study sites.

088-CL-01

Sponsor:
Crescendo Bioscience, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 80 Years (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
Subjects will be eligible to participate in the study if they meet all the following criteria:
1. Willing and able to sign an ICF
2. Age 18 to 80 years at enrollment
3. Meets the 2010 ACR/EULAR criteria and/or 1987 criteria for RA, as determined by a board-certified rheumatologist ≥3 months prior to enrollment
4. Received uninterrupted treatment with weekly MTX begun ≥3 months prior to enrollment, at a stable dose of ≥15 mg per week for at least 4 weeks prior to enrollment. A history of therapy with split dose oral MTX or parenteral MTX is acceptable only if the weekly MTX dose was always ≤20 mg/week during the 3 months prior to enrollment.
5. CDAI >10 as assessed by the Investigator at screening
6. At least 3 swollen joints (SJC ≥3) and 3 tender joints (TJC ≥3) out of 28 joints as assessed by the Investigator at screening
7. Must be eligible for treatment intensification with non-biologic and biologic DMARDs
8. Documented evidence of seropositivity (RF and/or anti-CCP antibodies). Seronegative subjects are allowed if erosive disease attributable to RA is documented on X-rays.

Exclusion Criteria:
Subjects will be ineligible to participate in the study if they meet any of the following criteria:
1. Use of a non-biologic DMARD other than MTX within 3 months prior to enrollment
2. MTX administered SQ or as an oral split dose at >20 mg/week any time during the 3 months prior to enrollment
3.Two or more DMARDs used in combination (i.e., concomitantly), including but not limited to: MTX, HCQ, SSZ, LEF, cyclosporine, azathioprine, gold or penicillamine any time prior to enrollment
4. Biologic DMARD or JAKi use any time prior to enrollment
5. Any contraindication to use of MTX, HCQ, LEF or biologic DMARDs
6. Opiate use during the 2 weeks prior to enrollment
7. Oral corticosteroids during the month prior to enrollment at a dosage >10 mg/day prednisone (or equivalent) or at a non-stable dose ≤10 mg/day prednisone (or equivalent)
8. MTX intolerance prior to enrollment that limits its use
9. Inflammatory joint disease (other than RA) or any other systemic autoimmune disorder. (Osteoarthritis is not a basis for exclusion.)
10. Primary or secondary immunodeficiency
11. Active infection (excluding fungal infection of nail beds); or acute or chronic infection requiring hospitalization or treatment with parenteral systemic antibiotics within one month of enrollment or treatment with oral antibiotics within 2 weeks of enrollment
12. IA, intravenous or IM corticosteroids during the month prior to enrollment
13. Initiation or non-stable dosing of NSAIDs within 2 weeks prior to enrollment
14. Vectra DA testing within 6 months prior to enrollment
15. Live vaccine within 90 days of enrollment
16. Active substance abuse or psychiatric illness likely to interfere with protocol conduct
17. History of severe allergic or anaphylactic reaction to any monoclonal antibody therapy
18. Known infection with HIV (HIV testing will not be a requirement for trial entry); a past or current history of hepatitis B virus or hepatitis C virus infection
19. History of malignancy within the past five years or any evidence of persistent malignancy, except fully excised basal cell or squamous cell carcinomas of the skin, or cervical carcinoma in situ that has been treated or excised in a curative procedure
20. Pregnancy or inadequate contraception in women of childbearing potential
21. Breast feeding or lactating
22. Medical, psychiatric, cognitive or other conditions that, in the opinion of the Investigator, may compromise the ability of the subject to understand the study information, to give informed consent, to comply with the trial protocol, or to complete the study
23. Presently enrolled in another clinical trial Note: Screening for TB is not required for subjects participating in the study. If an Investigator is considering a subject for treatment with a biologic DMARD in the study, guidelines for TB screening need to be followed.

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Asthma
Open to Enrollment

A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Existing Asthma Therapy in Patients With Uncontrolled Severe Asthma.

This study aims to determine the efficacy and safety of QAW039 (Dose 1 and Dose 2), compared with placebo, when added to GINA steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2015) in each of the groups (patients with severe asthma and high eosinophil...

Investigator:
Robert Sussman, MD

counts and all patients with severe asthma)

QAW039A2314 | PHASE III

Sponsor:
Novartis Pharmaceuticals Corporation - NJ

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 12 Years and older (Child, Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Written informed consent.
• Male and female patients aged ≥12 years.
• A diagnosis of severe asthma, uncontrolled on GINA 4/5 asthma medication.
• Evidence of airway reversibility or airway hyper- reactivity.
• FEV1 ≤80% of the predicted normal value for patients aged ≥18 years; FEV1 of ≤90% for patients aged 12 to <18 years
• An ACQ score ≥1.5
• A history of 2 or more asthma exacerbations within the 12 months prior to entering the study.

Exclusion Criteria:
• Use of other investigational drugs within 5 half-lives of study entry, or within 30 days, whichever is longer.
• Subjects who have participated in another trial of QAW039.
• A QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female).
• History of malignancy with the exception of local basal cell carcinoma of the skin.
• Pregnant or nursing (lactating) women.
• Serious co-morbidities.
• Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin.

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Asthma
Open to Enrollment

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo Controlled, Phase 3b Study to Evaluate the Safety and Efficacy of Benralizumab 30 mg sc in Patients With Severe Asthma Uncontrolled on Standard of Care Treatment

The purpose of this study is to investigate the effect of benralizumab on the rate of asthma exacerbations, patient reported quality of life and lung function during 24-week treatment in patients with uncontrolled, severe asthma with eosinophilic inflammation....

Investigator:
Robert Sussman, MD

A subset of patients will be assessed for their ongoing chronic rhinosinusitis with nasal polyps.

D3250C00045 | PHASE III

Sponsor:
AstraZeneca

Inclusion & Exclusion Criteria:
Ages Eligible for Study: Child, Adult, Senior
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Female and male patients aged 18 to 75 years inclusively at the time of Visit 1 with a history of physician-diagnosed asthma requiring treatment with medium-to-high dose Inhaled Corticosteroids (ICS) plus asthma controller, for at least 12 months prior to Visit 1.
2. Documented current treatment with high daily doses of ICS plus at least one other asthma controller for at least 3 months prior to Visit 1.
3. History of at least 2 asthma exacerbations while on ICS plus another asthma controller that required treatment with systemic corticosteroids (IM, IV, or oral) in the 12 months prior to Visit 1.
4. ACQ6 score ≥1.5 at Visit 1.
5. Screening pre-bronchodilator (pre-BD) FEV1 of <80% predicted at Visit 2 and airway reversibility (FEV1 ≥12%) demonstrated at Visit 2 or Visit 3.
6. Peripheral blood eosinophil count of ≥300 cells/μL assessed by central laboratory at Visit 1 or Visit 2.

Exclusion Criteria:
1. Clinically important pulmonary disease other than asthma
2. Acute upper or lower respiratory infections within 30 days prior to the date informed consent.
3. A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy.
4. History of alcohol or drug abuse within 12 months prior to the date informed consent is obtained.
5. A history of known immunodeficiency disorder.
6. Current smokers or former smokers with a smoking history of ≥10 pack years.
7. Previously received benralizumab (MEDI-563).
8. Receipt of any investigational medication as part of a research study within approximately 5 half-lives prior to randomization.
9. Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained.
10. Receipt of live attenuated vaccines 30 days prior to the date of randomization; other types of vaccines are allowed.
11. Concurrent enrolment in another interventional or post-authorization safety study

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Atrial Fibrillation
Open to Enrollment

LEFT ATRIAL APPENDAGE LIGATION WITH THE LARIAT+® SUTURE DELIVERY SYSTEM AS ADJUNCTIVE THERAPY TO PULMONARY VEIN ISOLATION FOR PERSISTENT OR LONGSTANDING PERSISTENT ATRIAL FIBRILLATION

This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an adjunct to planned pulmonary...

Investigator:
Timothy Mahoney, MD

vein isolation (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent atrial fibrillation.

aMAZE

Sponsor:
SentreHEART, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Documented diagnosis of symptomatic persistent or longstanding persistent non-valvular atrial fibrillation
• Failed at least one Class I or III Antiarrythmic drug (AAD)
• Life expectancy ≥ 1 year;
• Willing and able to return to and comply with scheduled follow-up visits and tests; and
• Willing and able to provide written informed consent

Exclusion Criteria:
• Prior procedure involving opening of the pericardium or entering the pericardial space (e.g., coronary artery bypass graft, heart transplantation, valve surgery) where adhesions are suspected;
• Prior epicardial or endocardial atrial fibrillation ablation procedure;
• LA diameter > 6 cm as measured by computerized tomography;
• Documented embolic stroke, transient ischemic attach or suspected neurologic event within 3 months prior to the planned intervention;
• Currently exhibits New York Heart Association Class IV heart failure symptoms;
• Documented history of right heart failure specifically when right ventricle exceeds the left ventricular size;
• Documented history of myocardial infarction (MI) within 3 months prior to the planned study intervention;
• Documented history of unstable angina within 3 months prior to the planned study intervention;
• Documented symptomatic carotid disease, defined as > 70% stenosis or > 50% stenosis with symptoms;
• End Stage Renal Disease (ESRD) or documented history of renal replacement / dialysis;
• Current documented history of clinically significant liver disease which predisposes the subject to significant bleeding risk (clinically defined by the treating physician);
• Any history of thoracic radiation with the exception of localized radiation treatment for breast cancer;
• Current documented use of long-term treatment with corticoid steroids, not including use of inhaled steroids for respiratory diseases;
• Active pericarditis;
• Active endocarditis;
• Any documented history or autoimmune disease associated with pericarditis;
• Evidence of Pectus Excavatum (documented and clinically defined by the treating physician);
• Untreated severe scoliosis (documented and clinically defined by treating physician);
• Documented Left Ventricular Ejection Fraction (LVEF) < 30% within 30 days prior to planned intervention;
• Documented presence of implanted congenital defect closure devices, (e.g., atrial septal defect, patent foramen ovale or ventricular septal defect device);
• Previously attempted occlusion of the left atrial appendage (by any surgical or percutaneous method);
• Body Mass Index (BMI) > 40;
• Evidence of active Graves disease;

Additional Exclusion Criteria: Based on Screening / Pre-procedure Imaging
Subjects will also be excluded if they meet any of the following:
• Based on screening computed tomography angiography performed within 90 days prior to study intervention as confirmed by the core lab:
◦Left atrial appendage morphology: Superior-posterior oriented left atrial appendage (i.e. superior C shape), that has:
a.Left atrial appendage LARIAT-approach width ≥ 40 mm; or
b.Left atrial appendage distal apex extending posterior to the ostium of the appendage.
◦Left atrial appendage positioned behind the pulmonary artery; or
◦All other left atrial morphology: Left atrial appendage LARIAT approach width > 45 mm.
• Based on a peri-procedural imaging (transesophageal echocardiography) at time of LARIAT or catheter ablation) and confirmed by institution's designated LARIAT echocardiographer:
◦Intracardiac thrombus; or
◦Significant mitral valve stenosis (i.e., mitral valve stenosis < 1.5cm2)

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Atrial Fibrillation
Open to Enrollment

reMARQable: nMARQ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation

To demonstrate safety and effectiveness of nMARQ Catheter System [nMARQ] compared with THERMOCOOL® Navigational Family of catheters in treating subjects with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF).

Investigator:
Jonathan Sussman, MD
nMARQ

Sponsor:
Biosense Webster, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Patients with symptomatic paroxysmal AF who have had at least one AF episode documented within one (1) year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.
2. Patients who have failed at least one antiarrhythmic drug (AAD; class I or III, or atrioventricular (AV) nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic AF, or intolerance to the AAD.
3. Age 18 years or older.
4. Signed Patient Informed Consent Form (ICF).
5. Able and willing to comply with all pre-, post-, and follow-up testing and requirements.

Exclusion Criteria:
1. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
2. Previous ablation for atrial fibrillation.
3. Patients on amiodarone at any time during the past 3 months prior to enrollment.
4. AF episodes lasting > 7 days.
5. Any cardiac surgery within the past 60 days (2 months) or valvular cardiac surgical procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
6. Coronary artery bypass graft (CABG) procedure within the last 180 days (6 months).
7. Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months).
8. Documented left atrial thrombus on imaging.
9. History of a documented thromboembolic event within the past one (1) year.
10. Diagnosed atrial myxoma.
11. Presence of implanted cardioverter defibrillator (ICD).
12. Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
13. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
14. Women who are pregnant (as evidenced by pregnancy test if subject is of child-bearing age and potential) or breast feeding.
15. Acute illness or active systemic infection or sepsis.
16. Unstable angina.
17. Myocardial infarction within the previous 60 days (2 months).
18. Left ventricular ejection fraction <40%.
19. History of blood clotting or bleeding abnormalities.
20. Contraindication to anticoagulation (i.e., heparin, dabigatran, Vitamin K Antagonists such as warfarin).
21. Life expectancy less than 365 days (12 months).
22. Enrollment in an investigational study evaluating another device or drug.
23. Uncontrolled heart failure or NYHA Class III or IV heart failure.
24. Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
25. Presence of a condition that precludes vascular access.
26. Left atrial size >50 mm.

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Bariatrics
Open to Enrollment

Bariatric Surgery for Adolescents with Associated Comorbidities and Body Mass Index (BMI) 35-39.9 kg/m2, or BMI ≥ 40 kg/m2

The principal goal of this prospective study is to establish the efficacy  of bariatric surgery to adolescent patients between the ages of 15-18 years old.  The study will evaluate improvement in comorbid conditions, quality of life, and lower BMI over a 2...

year time span.  The surgeries offered will be laparoscopic sleeve gastrectomy and laparoscopic gastric bypass. Improvement in weight and obesity-associated comorbidities will be measured at specific time intervals after surgery.

Adolescent Bariatric Registry

Sponsor:

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 15-18 Years Old
Genders Eligible for Study: Both

Inclusion Criteria:
Patient is an adolescent between the ages of 15-18 years old, has met the requirements for surgery and has been evaluated by one of the participating surgeons and is planned to undergo either sleeve gastrectomy or gastric bypass. The patient should have a body mass index (BMI) ≥ 35 kg/m2 and severe obesity-associated comorbidities (i.e. diabetes mellitus, hypertension, sleep apnea, coronary artery disease, fatty liver disease, polycystic ovarian syndrome, gastroesophageal reflux disease, dyslipidemia), or a BMI ≥ 40 kg/m2

Exclusion Criteria:
1. No exclusion criteria other than not meeting the inclusion criteria.
2. There are no exclusions based on gender, race or ethnic background

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Bariatrics
Open to Enrollment

Bariatric Surgery for Low BMI Patients, a Registry Study

The principal goal of this prospective study is to establish the efficacy of bariatric surgery in patients with body mass index (BMI) between 30.0-34.9 kg/m2 with obesity-related comorbidities or BMI 35 - 40 kg/m2 without comorbidities. In addition, this study...

will evaluate any changes in the patients’ comorbidities. The surgeries offered will be laparoscopic sleeve gastrectomy and laparoscopic gastric bypass. Improvement in weight and obesity-associated comorbidities will be measured at specific time intervals after surgery.

Bariatric Registry

Sponsor:

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and Older
Genders Eligible for Study: Both

Inclusion Criteria:
1.Patient has been evaluated by one of the participating surgeons and is planned to undergo either sleeve gastrectomy or gastric bypass. The patient should have a body mass index (BMI) 30-34.9 kg/m2 and obesity-associated comorbidities (i.e. diabetes mellitus, hypertension, sleep apnea, coronary artery disease, depression, polycystic ovarian syndrome, gastroesophageal reflux disease, dyslipidemia), or a BMI ≥ 35 kg/m2

Exclusion Criteria:
1. No exclusion criteria other than not meeting the inclusion criteria.
2. There are no exclusions based on gender, race or ethnic background.

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Bladder Cancer
Open to Enrollment

An Open-Label, Multi-Centre, Safety Study of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies.

To evaluate the safety, tolerability, and anti-tumor activity of the combination of durvalumab + tremelimumab or durvalumab alone in different solid tumors.

Investigator:
Dennis Lowenthal, MD
D4191C00068 | PHASE III

Sponsor:
AstraZeneca

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Age ≥ 18 years at the time of screening. For patients aged <20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative
2. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act in the US, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
3. Disease not amendable to curative surgery
4. Eastern Cooperative Oncology Group (ECOG) performance status as defined in the specific module.
5. Body weight >30 kg.
6. No prior exposure to anti-programmed death (PD) 1 or anti-PD-ligand (L) 1.
7. Adequate organ and marrow function.
8. Female patients of childbearing potential (i.e., not surgically sterile or post-menopausal) who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception from the time of screening and must agree to continue using such precautions for 180 days after the last dose of investigational product (IP).
9 .Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
◦ Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
◦ Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
10. Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide from screening through 180 days after the last dose of IP.

For inclusion in the Module A of the study patients should fulfill the following criteria:
1. Histologically or cytologicaly confirmed locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract (including the urinary bladder, ureter, urethra and renal pelvis)
2. Disease that has progressed during or after at least one previous platinum or nonplatinum based chemotherapy, either for metastatic disease or progressive disease less than 12 months after adjuvant or neo-adjuvant chemotherapy
3. ECOG performance status 0-2

Exclusion Criteria:
1. Involvement in the planning and/or conduct of the study.
2. Previous IP assignment in the present study.
3. Concurrent enrollment in another clinical study or another sub-study of this protocol, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
4. Participation in another clinical study with an IP and receipt of any investigational anticancer therapy during the last / within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment.
5. Any concurrent chemotherapy, investigational agent, biologic, or hormonal therapy for cancer treatment.
6. Local treatment of isolated lesions for palliative intent is acceptable (e.g., local surgery or radiotherapy).
7. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.
8. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
9. History of allogenic organ transplantation.
10. Uncontrolled intercurrent illness (ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
11. History of another primary malignancy, leptomeningeal carcinomatosis and active primary immunodeficiency.
12. Has untreated central nervous system (CNS) metastases and/or carcinomatous meningitis identified either on baseline brain imaging (please refer to RECIST for details on the imaging modality) obtained during the screening period or identified prior to signing the ICF
13. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (positive HIV ½ antibodies).
14. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab.
15. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]).
16. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
17. Known allergy or hypersensitivity to study drug(s) or compounds of similar biologic composition to the study drug(s), or any of the study drug excipients.
18. Any unresolved NCI CTCAE Grade ≥2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia, and the laboratory values defined in the inclusion criteria.
19. Pregnant or breastfeeding women or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy or 180 days after the last dose of durvalumab + tremelimumab combination therapy.
20. Prior randomization or treatment in a previous durvalumab and/or tremelimumab clinical study regardless of treatment arm assignment.

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Bladder Cancer
Open to Enrollment

Open-Label, Multicenter, Ph 3 Study to Evaluate the Efficacy and Tolerability of Intravesical Vicinium™ in Subjects With Non Muscle-Invasive Carcinoma in Situ and/or High-Grade Papillary Disease of the Bladder Treated With BCG

Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS, high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy. Vicinium is an experimental agent that may provide an alternative...

Investigator:
Ayal Kaynan, MD

to cystectomy

VB4-845-02-IIIA | PHASE III

Sponsor:
Viventia Bio Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Histologically-confirmed non muscle-invasive bladder cancer - CIS, high grade Ta or any grade T1 papillary disease or CIS plus papillary disease following adequate BCG treatment.
2. The CIS, Ta or T1 disease is documented as unresponsive to (i.e., not intolerant) adequate BCG therapy. Adequate BCG therapy is defined as at least 7 instillations of BCG over 2 cycles. (1 induction course of at least 5 doses over 6 weeks + 1 maintenance cycle of at least 2 doses over 6 weeks, or up to 2 induction courses) of BCG (with or without interferon).
3. Male or non-pregnant, non-lactating female.
4. Females of childbearing potential and all males with partners of childbearing age are eligible only if they agree to use highly effective contraceptive techniques or abstinence during the 24-month study period.
5. Bladder biopsy mapping the location of the tumors and quantifying the affected area of bladder within 8 weeks before study drug administration.
6. Life expectancy of at least 4 years.
7. Adequate organ function, as defined by the following criteria:
a. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x upper limit of normal (ULN);
b. Total serum bilirubin ≤1.5 x ULN (CTCAE Grade ≤1);
c. Serum creatinine ≤2.0 x ULN; subjects with serum creatinine >1 x ULN must also have creatinine clearance ≥50 mL/min;
d. Hemoglobin ≥8.0 g/dL; subjects receiving therapeutic erythropoietin preparations (i.e., epoetin alfa, darbepoetin alfa) are eligible to enroll;
e. Absolute neutrophil count ≥1500 x 109/L;
f. Platelets ≥75,000 x 109/L.
8. Ability to understand and sign an Independent Ethics Committee- or Institutional Review Board-approved informed consent document.

Exclusion Criteria:
1. The subject is pregnant or breastfeeding.
2. Evidence of urethral or upper tract transitional cell carcinoma (TCC) by biopsy or upper tract radiological imaging or evidence of higher stage disease by pelvic imaging within the past 2 years .
3. Subjects with hydronephrosis, except for those subjects where hydronephrosis has been longstanding (i.e., predates the diagnosis of the CIS, Ta or T1 by more than 2 years) and diagnostic evaluation at screening shows no evidence of tumor.
4. Any intravesicular or other chemotherapy treatment within 2 weeks or any investigational agent within 4 weeks prior to the initial dose of study drug.
5. Current severe urinary tract infection or history of recurrent severe bacterial cystitis.
6. Active, uncontrolled impairment of the urogenital, renal, hepatobiliary, cardiovascular, gastrointestinal, neurologic or hematopoietic systems which, in the opinion of the Investigator, would predispose the subject to the development of complications from the administration of intravesical therapy and/or general anesthesia.
7. History of other primary malignancy (other than squamous or basal cell skin cancers) that will require concomitant cancer therapy during the 24 months of the study.
8. A QTc interval of >450 msec for males or > 470 msec for females at the Screening ECG.
9. Subjects who, in the opinion of the Investigator, cannot tolerate intravesical administration or intravesical surgical manipulation.

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Bowel Disease
Open to Enrollment

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children, Ages 6 to 17 Years, A Multicenter, Randomized, Double-blind, Placebo-controlled Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation (IBS-C) (ie, Fulfill Rome III Criteria for Child/Adolescent IBS and Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation

The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of Irritable Bowel syndrome with Constipation (IBS-C), in children age 7-17 years. This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment...

Investigator:
Alycia Leiby, MD

Period. Patients age 7-11 will receive oral liquid or oral solid capsule and patients 12-17 will receive solid oral capsule formulation. Children ages 7-11 years meeting the entry criteria will be randomized to 1 of 3 doses of linaclotide or placebo for 4 weeks. Children ages 12-17 years meeting the entry criteria will be randomized to 1 of 4 doses of linaclotide or placebo for 4 weeks. This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of IBS-C.

LIN-MD-63 | PHASE II

Sponsor:
Forest Research Institute, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 7 Years to 17 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Patient weighs at least 18 kg (39.7 lbs)
• Patient meets Rome III criteria for child/adolescent IBS: at least once per week for at least 2 months before Screening Visit, the patient experienced abdominal discomfort (an uncomfortable sensation not described as pain) or pain associated with 2 or more of the following at least 25% of the time:
a. Improvement with defecation
b. Onset associated with a change in frequency of stool
c. Onset associated with a change in form (appearance) of stool
• Patient meets modified Rome III criteria for child/adolescent Functional Constipation (FC): For at least 2 months before the Screening Visit, the patient has had 2 or fewer defecations (with each defecation occurring in the absence of any laxative, suppository, or enema use during the preceding 24 hours) in the toilet per week. In addition, at least once per week, patient meets 1 or more of the following:
a. History of retentive posturing or excessive volitional stool retention
b. History of painful or hard bowel movements (BMs)
c. Presence of a large fecal mass in the rectum
d. History of large diameter stools that may obstruct the toilet
• Patient is willing to discontinue any laxatives used before the Pretreatment Visit in favor of the protocol-permitted rescue medicine
• Patient has an average of fewer than 3 spontaneous BMs (SBMs) per week during the 14 days before the randomization day and up to the randomization. An SBM is defined as a BM that occurs in the absence of laxative, enema, or suppository use on the calendar day of the BM or the calendar day before the BM
• Patient or parent/guardian/LAR or caregiver is compliant with eDiary by completing both the morning and evening assessments for 10 out of the 14 days immediately preceding the Randomization Visit

Exclusion Criteria:
• Patient reports having more than 1 loose, mushy stool (eDiary-recorded stool consistency of 6 on the Pediatric Bristol Stool Form Scale [p-BSFS]) or any watery stool (eDiary-recorded stool consistency of 7 on the p-BSFS) with any SBM that occurred in the absence of laxative use on the calendar day of the BM or the calendar day before the BM during the 14 days before the randomization day and up to the randomization
• Select medical history or conditions that may be related to other causes of constipation or may interfere with safety and efficacy analyses
• Patient has required manual or hospital-based disimpaction any time prior to randomization
• Patient is unable to tolerate the placebo during the Screening Period

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Bowel Disease
Open to Enrollment

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children, Ages 6 to 17 Years, Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC)

The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of functional constipation (FC), in children age 6-17 years This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients...

Investigator:
Alycia Leiby, MD

age 6-11 will receive oral liquid formulation and patients 12-17 will receive solid oral capsule or liquid oral solution. Children ages 6-11 years meeting the entry criteria will be randomized to 1 of 3 doses of linaclotide or placebo for 4 weeks. Children ages 12-17 years meeting the entry criteria will be randomized to 1 of 4 doses of linaclotide or placebo for 4 weeks. This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of FC.

LIN-MD-62 | PHASE II

Sponsor:
Forest Research Institute, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 6 Years to 17 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Patient weighs at least 18 kg (39.7 lbs)
• Patient meets modified Rome III criteria for child/adolescent FC: For at least 2 months before the Screening Visit, the patient has had 2 or fewer defecations (with each defecation occurring in the absence of any laxative, suppository, or enema use during the preceding 24 hours) in the toilet per week
• In addition, at least once per week, patient meets 1 or more of the following:
a. History of retentive posturing or excessive volitional stool retention
b. History of painful or hard bowel movements (BMs)
c. Presence of a large fecal mass in the rectum
d. History of large diameter stools that may obstruct the toilet
• Patient is willing to discontinue any laxatives used before the Pretreatment Visit in favor of the protocol-permitted rescue medicine
• Patient has an average of fewer than 3 spontaneous BMs (SBMs) per week during the 14 days before the randomization day and up to the randomization. An SBM is defined as a BM that occurs in the absence of laxative, enema, or suppository use on the calendar day of the BM or the calendar day before the BM
• Patient or parent/guardian/LAR or caregiver is compliant with eDiary by completing both the morning and evening assessments for 10 out of the 14 days immediately preceding the Randomization Visit

Exclusion Criteria:
• Patient meets Rome III criteria for Child/Adolescent irritable bowel syndrome (IBS): At least once per week for at least 2 months before the Screening Visit, the patient has experienced abdominal discomfort (an uncomfortable sensation not described as pain) or pain associated with 2 or more of the following at least 25% of the time:
a. Improvement with defecation
b. Onset associated with a change in frequency of stool
c. Onset associated with a change in form (appearance) of stool
• Patient reports having more than 1 loose, mushy stool (eDiary-recorded stool consistency of 6 on the Pediatric Bristol Stool Form Scale [p-BSFS]) or any watery stool (eDiary-recorded stool consistency of 7 on the p-BSFS) with any SBM that occurred in the absence of laxative use on the calendar day of the BM or the calendar day before the BM during the 14 days before the randomization day and up to the randomization
• Select medical history or conditions that may be related to other causes of constipation or may interfere with safety and efficacy analyses
• Patient has required manual or hospital-based disimpaction any time prior to randomization
• Patient is unable to tolerate the placebo during the Screening Period

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973-971-7747
research@atlantichealth.org

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Bowel Disease
Open to Enrollment

A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's Disease

The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants with moderately to severely active Crohn's disease.

Investigator:
Razvan Arsenescu, MD
64304500CRD2001 | PHASE II

Sponsor:
Janssen R & D

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Have Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
• A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [b-hCG]) pregnancy test result at screening and a negative urine pregnancy test result at Week 0
• Adhere to the following requirements for concomitant medication for the treatment of Crohn's disease, which are permitted provided that doses meeting these requirements are stable, or have been discontinued, for at least 3 weeks before baseline (Week 0), unless otherwise specified: a) Oral 5-aminosalicylic acid (5-ASA) compounds, b) Oral corticosteroids at a prednisone-equivalent dose at or below 40 milligram per day (mg/day), or 9 mg/day of budesonide, or 5 mg/day beclomethasone dipropionate, c) Antibiotics being used as a primary treatment of Crohn's disease, d) Conventional immunomodulators (that is, azathioprine (AZA), 6-mercaptopurine (6-MP), or Methotrexate (MTX)): participants must have been taking them for at least 12 weeks and at a stable dose for at least 4 weeks before baseline
• A participant who has had extensive colitis for greater than or equal to (>=) 8 years, or disease limited to the left side of the colon for >= 12 years, must either have had a colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study agent or a colonoscopy to assess for the presence of malignancy at the screening visit, with no evidence of malignancy
• Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index (CDAI) score of >= 220 but <= 450

Exclusion Criteria:
• Participants who have received intravenous (IV) corticosteroids less then (<)3 weeks or have received tumor necrosis factor-alpha (TNF-alpha) antagonist biologic agents (example, monoclonal antibody [mAb] therapies) or other agents intended to suppress or eliminate tumor necrosis factor-alpha (TNF-alpha) <8 weeks or have received Vedolizumab <16 weeks before the first administration of study drug
• Woman who is pregnant or planning pregnancy or is a man who plans to father while enrolled in the study or within 16 weeks after the last administration of study agent
• Participants with certain complications of Crohn's disease that would make it hard to assess response to study drug
• Participants with a history of or ongoing chronic or recurrent infectious disease
• Has previously received a biologic agent targeting interleukin (IL)-12 or IL-23, including but not limited to ustekinumab or briakinumab (ABT-874)

Contact:
973-630-2233
research@atlantichealth.org

More info:
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Bowel Disease
Open to Enrollment

A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's Disease

The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants with moderately to severely active Crohn's disease.

Investigator:
Razvan Arsenescu, MD
64304500CRD2001 | PHASE II

Sponsor:
Janssen R & D

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Have Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
• A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [b-hCG]) pregnancy test result at screening and a negative urine pregnancy test result at Week 0
• Adhere to the following requirements for concomitant medication for the treatment of Crohn's disease, which are permitted provided that doses meeting these requirements are stable, or have been discontinued, for at least 3 weeks before baseline (Week 0), unless otherwise specified: a) Oral 5-aminosalicylic acid (5-ASA) compounds, b) Oral corticosteroids at a prednisone-equivalent dose at or below 40 milligram per day (mg/day), or 9 mg/day of budesonide, or 5 mg/day beclomethasone dipropionate, c) Antibiotics being used as a primary treatment of Crohn's disease, d) Conventional immunomodulators (that is, azathioprine (AZA), 6-mercaptopurine (6-MP), or Methotrexate (MTX)): participants must have been taking them for at least 12 weeks and at a stable dose for at least 4 weeks before baseline
• A participant who has had extensive colitis for greater than or equal to (>=) 8 years, or disease limited to the left side of the colon for >= 12 years, must either have had a colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study agent or a colonoscopy to assess for the presence of malignancy at the screening visit, with no evidence of malignancy
• Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index (CDAI) score of >= 220 but <= 450

Exclusion Criteria:
• Participants who have received intravenous (IV) corticosteroids less then (<)3 weeks or have received tumor necrosis factor-alpha (TNF-alpha) antagonist biologic agents (example, monoclonal antibody [mAb] therapies) or other agents intended to suppress or eliminate tumor necrosis factor-alpha (TNF-alpha) <8 weeks or have received Vedolizumab <16 weeks before the first administration of study drug
• Woman who is pregnant or planning pregnancy or is a man who plans to father while enrolled in the study or within 16 weeks after the last administration of study agent
• Participants with certain complications of Crohn's disease that would make it hard to assess response to study drug
• Participants with a history of or ongoing chronic or recurrent infectious disease
• Has previously received a biologic agent targeting interleukin (IL)-12 or IL-23, including but not limited to ustekinumab or briakinumab (ABT-874)

Contact:
973-630-2233
research@atlantichealth.org

More info:
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Bowel Disease
Open to Enrollment

A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's Disease

The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants with moderately to severely active Crohn's disease.

Investigator:
Razvan Arsenescu, MD
64304500CRD2001 | PHASE II

Sponsor:
Janssen R & D

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Have Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
• A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [b-hCG]) pregnancy test result at screening and a negative urine pregnancy test result at Week 0
• Adhere to the following requirements for concomitant medication for the treatment of Crohn's disease, which are permitted provided that doses meeting these requirements are stable, or have been discontinued, for at least 3 weeks before baseline (Week 0), unless otherwise specified: a) Oral 5-aminosalicylic acid (5-ASA) compounds, b) Oral corticosteroids at a prednisone-equivalent dose at or below 40 milligram per day (mg/day), or 9 mg/day of budesonide, or 5 mg/day beclomethasone dipropionate, c) Antibiotics being used as a primary treatment of Crohn's disease, d) Conventional immunomodulators (that is, azathioprine (AZA), 6-mercaptopurine (6-MP), or Methotrexate (MTX)): participants must have been taking them for at least 12 weeks and at a stable dose for at least 4 weeks before baseline
• A participant who has had extensive colitis for greater than or equal to (>=) 8 years, or disease limited to the left side of the colon for >= 12 years, must either have had a colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study agent or a colonoscopy to assess for the presence of malignancy at the screening visit, with no evidence of malignancy
• Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index (CDAI) score of >= 220 but <= 450

Exclusion Criteria:
• Participants who have received intravenous (IV) corticosteroids less then (<)3 weeks or have received tumor necrosis factor-alpha (TNF-alpha) antagonist biologic agents (example, monoclonal antibody [mAb] therapies) or other agents intended to suppress or eliminate tumor necrosis factor-alpha (TNF-alpha) <8 weeks or have received Vedolizumab <16 weeks before the first administration of study drug
• Woman who is pregnant or planning pregnancy or is a man who plans to father while enrolled in the study or within 16 weeks after the last administration of study agent
• Participants with certain complications of Crohn's disease that would make it hard to assess response to study drug
• Participants with a history of or ongoing chronic or recurrent infectious disease
• Has previously received a biologic agent targeting interleukin (IL)-12 or IL-23, including but not limited to ustekinumab or briakinumab (ABT-874)

Contact:
973-630-2233
research@atlantichealth.org

More info:
ClinicalTrials.gov

More Detail
Bowel Disease
Open to Enrollment

A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's Disease

The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants with moderately to severely active Crohn's disease.

Investigator:
Razvan Arsenescu, MD
64304500CRD2001 | PHASE II

Sponsor:
Janssen R & D

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Have Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
• A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [b-hCG]) pregnancy test result at screening and a negative urine pregnancy test result at Week 0
• Adhere to the following requirements for concomitant medication for the treatment of Crohn's disease, which are permitted provided that doses meeting these requirements are stable, or have been discontinued, for at least 3 weeks before baseline (Week 0), unless otherwise specified: a) Oral 5-aminosalicylic acid (5-ASA) compounds, b) Oral corticosteroids at a prednisone-equivalent dose at or below 40 milligram per day (mg/day), or 9 mg/day of budesonide, or 5 mg/day beclomethasone dipropionate, c) Antibiotics being used as a primary treatment of Crohn's disease, d) Conventional immunomodulators (that is, azathioprine (AZA), 6-mercaptopurine (6-MP), or Methotrexate (MTX)): participants must have been taking them for at least 12 weeks and at a stable dose for at least 4 weeks before baseline
• A participant who has had extensive colitis for greater than or equal to (>=) 8 years, or disease limited to the left side of the colon for >= 12 years, must either have had a colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study agent or a colonoscopy to assess for the presence of malignancy at the screening visit, with no evidence of malignancy
• Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index (CDAI) score of >= 220 but <= 450

Exclusion Criteria:
• Participants who have received intravenous (IV) corticosteroids less then (<)3 weeks or have received tumor necrosis factor-alpha (TNF-alpha) antagonist biologic agents (example, monoclonal antibody [mAb] therapies) or other agents intended to suppress or eliminate tumor necrosis factor-alpha (TNF-alpha) <8 weeks or have received Vedolizumab <16 weeks before the first administration of study drug
• Woman who is pregnant or planning pregnancy or is a man who plans to father while enrolled in the study or within 16 weeks after the last administration of study agent
• Participants with certain complications of Crohn's disease that would make it hard to assess response to study drug
• Participants with a history of or ongoing chronic or recurrent infectious disease
• Has previously received a biologic agent targeting interleukin (IL)-12 or IL-23, including but not limited to ustekinumab or briakinumab (ABT-874)

Contact:
973-630-2233
research@atlantichealth.org

More info:
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Bowel Disease
Open to Enrollment

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to evaluate the efficacy and safety of ustekinumab as intravenous (IV: into the vein) infusion in induction study in participants with moderately to severely active Ulcerative Colitis (UC) and as subcutaneous (SC) administration...

Investigator:
Razvan Arsenescu, MD

in maintenance study in participants with moderately to severely active Ulcerative Colitis (UC) who have demonstrated a clinical response to Induction treatment with IV ustekinumab.

CNTO1275UCO3001 | PHASE III

Sponsor:
Janssen R & D

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Has a clinical diagnosis of Ulcerative Colitis (UC) at least 3 months before Screening
• Has moderately to severely active UC, defined as a Baseline (Week 0) Mayo score of 6 to 12, including a Screening endoscopy subscore of the Mayo score greater than or equal to (>=) 2 as determined by a central reading of the video endoscopy
• Have failed biologic therapy, that is, have received treatment with 1 or more tumour necrosis factor (TNF) antagonists or vedolizumab at a dose approved for the treatment of UC, and have a documented history of failure to respond to or tolerate such treatment; OR Be naïve to biologic therapy (TNF antagonists or vedolizumab) or have received biologic therapy but have not demonstrated a history of failure to respond to, or tolerate, a biologic therapy and have a prior or current UC medication history that includes at least 1 of the following: a. Inadequate response to or failure to tolerate current treatment with oral corticosteroids or immunomodulators (6-mercaptopurine [6-MP] or azathioprine [AZA]) OR b. History of failure to respond to, or tolerate, at least 1 of the following therapies: oral or IV corticosteroids or immunomodulators (6-MP or AZA) OR c. History of corticosteroid dependence (that is, an inability to successfully taper corticosteroids without a return of the symptoms of UC)
• Before the first administration of study agent, the following conditions must be met: vedolizumab must have been discontinued for at least 4 months and anti-tumor necrosis factors (TNFs) for at least 8 weeks

Exclusion Criteria:
• Has severe extensive colitis and is at imminent risk of colectomy
• Has UC limited to the rectum only or to < 20 centimeters (cm) of the colon
• Presence of a stoma or history of a fistula
• Participants with history of extensive colonic resection (for example, less than 30 cm of colon remaining) that would prevent adequate evaluation of the effect of study agent on clinical disease activity
• Participants with history of colonic mucosal dysplasia. Participants will not be excluded from the study because of a pathology finding of "indefinite dysplasia with reactive atypia''

Contact:
973-630-2232
research@atlantichealth.org

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Bowel Disease
Open to Enrollment

A Prospective, Multi-center Registry for Patients With Short Bowel Syndrome

This is a global prospective, observational, multi-center registry to evaluate the long-term safety profile for patients with short bowel syndrome (SBS) who are treated with teduglutide in a routine clinical setting. The registry will also evaluate the long-term...

Investigator:
Michael Rothkopf, MD

clinical outcomes in patients with SBS. SBS patients treated and not treated with teduglutide will be enrolled.

TED-R13-002

Sponsor:
NPS Pharmaceuticals, Inc.

Inclusion & Exclusion Criteria:
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample
Study Population

This registry is to enroll both male and female patients, of any age, with a diagnosis of SBS.
Criteria

Inclusion Criteria:
- Male and female patients, of any age, with a diagnosis of SBS
- Signed informed consent and medical records release by the patient or a legally acceptable representative

Exclusion Criteria:
- None

Contact:
973-971-7101
research@atlantichealth.org

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Bowel Disease
Open to Enrollment

An Open-Label, Multicenter, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn's Disease Who Are Receiving Vedolizumab Therapeutically

The purpose of this study is to assess the concentration of vedolizumab in breast milk of lactating women with active ulcerative colitis (UC) or Crohn's disease (CD) who are receiving vedolizumab therapeutically.

Investigator:
Razvan Arsenescu, MD
Vedolizumab-4001 | PHASE IV

Sponsor:
Takeda Development Center Americas, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Female
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Is capable of understanding and complying with protocol requirements.
2. Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
3. Is female and at least 18 years of age at the time of informed consent.
4. Weighs at least 50 kilogram at Screening and Day 1.
5. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent and throughout the duration of the study.
6. Is on established vedolizumab maintenance therapy of (received at least two 300 mg once every 8 weeks doses prior to the delivery of infant and one 300 mg once every 8 weeks dose of vedolizumab postpartum), which has been commenced by the participant's treating physician for the treatment of active UC or CD prior to enrolling in this study.
7. Has delivered a single, normal term infant (at least 37 weeks' gestation) that is, a mother-infant pair is required.
8. Is at least 6 weeks postpartum by Day 1.
9. Lactation is well established and the mother is exclusively breast feeding their infant (or not providing more than 1 supplemental bottle of formula/day) when enrolled in the study.
10. Participant has independently decided to be treated with vedolizumab or to breastfeed prior to providing consent to participate in this study.
11. Plans to continue breastfeeding at least throughout the duration of this study.
12. Agrees to use only the emollient or nipple cream recommended by the investigator for use during the sampling period as described per protocol.

Exclusion Criteria:
1. Has received any investigational compound or approved biologic or biosimilar agent, except for vedolizumab within 60 days prior to enrollment in the study.
2. Within 30 days prior to enrollment, the participant has received any of the following for the treatment of underlying disease:
a. Nonbiologic therapies [example (eg), cyclosporine], other than those listed in the protocol.
b. An approved nonbiologic therapy in an investigational protocol.
3. Is expected to receive additional vedolizumab treatment between Day 2 and Study Exit/Follow-up (Day 57).
4. Has received natalizumab treatment.
5. Has received any live vaccinations within 30 days prior to study drug administration.
6. Has a positive test result for hepatitis B surface antigen, antibody to hepatitis C virus, at Screening or a known history of human immunodeficiency virus infection (eg, common variable immunodeficiency, human immunodeficiency virus infection, organ transplantation).
7. Has clinically significant infection (eg, pneumonia, pyelonephritis) or chronic infection within 30 days prior to enrollment.
8. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
9. Has evidence of unstable or uncontrolled, clinically significant cardiovascular, central nervous system, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic or other medical disorder, including serious allergy, asthma, hypoxemia, hypertension, seizures or allergic skin rash that, in the opinion of the investigator, would confound the study results or compromise participant safety. Additionally, if there is any finding in the participant's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking vedolizumab, or a similar drug that might interfere with the conduct of the study.
10. Had any surgical procedure requiring general anesthesia within 30 days prior to enrollment or is planning to undergo major surgery during the study period.
11. Has any history of malignancy, except for the following: (a) adequately treated nonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to enrollment; and (c) history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to enrollment. Participants with remote history of malignancy (eg, greater than (>) 10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received and must be discussed with the sponsor on a case-by-case basis prior to enrollment.
12. Has a positive progressive multifocal leukoencephalopathy subjective symptom checklist at screening.
13. Has a current or recent history (within 1 year prior to enrollment) of alcohol dependence or illicit drug use.
14. Has active psychiatric problems that, in the investigator's opinion, may interfere with compliance with the study procedures.
15. Has history of breast implants, breast augmentation, or breast reduction surgery.
16. Has a prior history of difficulty establishing lactation.
17. Has a positive urine/blood drug result for drugs of abuse (defined as any illicit drug use) at Screening.
18. Has donated or lost 450 milliliter or more of her blood volume (including plasmapheresis), or had a transfusion of any blood product within 45 days prior to Day 1.
19. Has active or latent tuberculosis (TB)

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Bowel Disease
Open to Enrollment

An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Triple Combination Therapy With Vedolizumab IV, Adalimumab SC, and Oral Methotrexate in Early Treatment of Subjects With Crohn's Disease Stratified at Higher Risk for Developing Complications

The purpose of this study is to determine the effect of triple combination therapy with an anti-integrin [vedolizumab intravenous (IV)], a tumor necrosis factor (TNF) antagonist [adalimumab subcutaneously (SC)], and an immunomodulator (oral methotrexate) on...

Investigator:
Razvan Arsenescu, MD

endoscopic remission in participants with newly-diagnosed Crohn's disease stratified at higher risk for complications.

Vedolizumab-4006 | PHASE IV

Sponsor:
Takeda Development Center Americas, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:
1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
2. The participant or, when applicable, the participant's legally acceptable representative has signed and dated a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
3. Is male or non-pregnant, non-breast-feeding female and aged 18 to 80 years, inclusive at time of Screening.
4. Has an initial diagnosis of Crohn's disease (CD) established within 24 months prior to enrollment with involvement of the ileum and/or colon that can be assessed by ileocolonoscopy.
5. Has moderate to severely active CD during Screening defined by:
1. Crohn's disease activity index (CDAI) score ≥ 220 within 10 days prior to enrollment, AND
2. Centrally assessed simple endoscopic score for Crohn's disease (SES-CD) score ≥7 (or ≥4 if isolated ileal disease) during Screening, AND
3. Elevated biomarker of inflammation [C-reactive protein (CRP) >5 mg/L OR fecal calprotectin level >250 μg/g stool) during Screening.
6. By investigator judgement, the participant is assessed as having CD at moderate-high risk for complications. Investigator judgement may include clinical assessment, the Crohn's Disease Personalized Risk and Outcome Prediction Tool (PROSPECT), or criteria defined by the 2014 American Gastroenterology Association (AGA) CD Clinical Care Pathway.
7. May be receiving a stable therapeutic dose of conventional therapies for CD.
8. If on corticosteroids, must be on a stable dose of oral corticosteroids up to 20 mg of prednisone daily or 9 mg of budesonide daily for at least 7 days prior to enrollment.
9. If on corticosteroids, must be willing to follow a mandatory taper of prednisone or budesonide within 60 days after enrollment.
10. Must be willing to stop treatment with 5-aminosalicylate (5-ASA), antibiotics, and probiotics for luminal CD at enrollment.
11. Male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
12. Female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
13. Family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factors must be up-to-date on colorectal cancer surveillance (may be performed during Screening as standard of care).

Exclusion Criteria:

Gastrointestinal (GI) Exclusion Criteria
1. Has a diagnosis of ulcerative colitis (UC) or indeterminate colitis.
2. Has clinical evidence of a current abdominal abscess or a history of prior abdominal abscess.
3. Has a known perianal fistula with abscess. (The participant may have a perianal fistula without abscess.)
4. Has a known fistula (other than perianal fistula).
5. Had non-CD related abdominal surgery within 6 months prior to enrollment.
6. Has any prior CD-related surgery OR CD complication requiring surgery at any time (other than seton placement for perianal fistula without abscess).
7. Has a history of 2 or more non CD related small bowel resections or diagnosis of short bowel syndrome.
8. Has extensive non CD related colonic resection, ie, subtotal or total colectomy with <15 cm colon remaining.
9. Has an ileostomy, colostomy.
10. Has a history or evidence of adenomatous colonic polyps that have not been removed.
11. Has a history or evidence of colonic mucosal dysplasia.
12. Has intolerance or contraindication to undergo ileocolonoscopy.
13. Has known fixed stricture or stenosis of the intestine.

Infectious Disease Exclusion Criteria
14. Has any identified congenital or acquired immunodeficiency [eg, common variable immunodeficiency, human immunodeficiency virus (HIV) infection].
15. Has undergone organ transplantation.
16. Has evidence of an active infection during Screening.
17. Infections requiring treatment with oral (PO) or intravenous (IV) antibiotics, antivirals, or antifungals within 28 days of enrollment.
18. Has active or latent tuberculosis (TB), regardless of treatment history, as evidenced by any of the following:
1. History of TB.
2 .A diagnostic TB test performed during Screening that is positive, as defined by:
• A positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests OR
3. A tuberculin skin test reaction ≥10 mm (≥5 mm in participants receiving the equivalent of >15 mg/day prednisone)
19. Has a history of listeria, histoplasmosis, coccidioidomycosis, blastomycosis, candidiasis, aspergillosis, legionella, or pneumocystosis.
20. Has a history of any bacterial, viral, and other infection due to opportunistic pathogens.
21. Has chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
22. Has evidence of active Clostridium difficile infection or is having treatment for C. difficile infection or other intestinal pathogens during Screening.
23. Has received any live vaccinations within 28 days prior to enrollment.

General Exclusion Criteria
24. Has other inflammatory or rheumatic diseases (eg, psoriasis, rheumatoid arthritis, ankylosing spondylitis).
25. Had a surgical procedure requiring general anesthesia within 60 days prior to enrollment or is planning to undergo major surgery during the study period.
26. Is taking, has taken, or is required to take any excluded medications.
27. Has received either approved or investigational biologic or nonbiologic agents for the treatment of inflammatory bowel disease (IBD) in an investigational protocol.
28. Has had prior exposure to any tumor necrosis factor (TNF) antagonist including infliximab, certolizumab pegol, golimumab, adalimumab, or biosimilar TNF antagonist agents.
29. Has had prior exposure to vedolizumab, natalizumab, efalizumab, or rituximab.
30. Has received either approved or investigational biologic agents for the treatment of non-inflammatory bowel disease (IBD) conditions, other than localized injections (eg, intraocular injections for wet macular degeneration).
31. Has a history of hypersensitivity or allergies to methotrexate, vedolizumab, adalimumab, or their components.
32. Has a medical history that contraindicates the use of vedolizumab, adalimumab, or methotrexate as per each drug's package insert.
33. Has conditions which, in the opinion of the investigator, may interfere with the participant's ability to comply with the study procedures.
34. Has a history of any lymphoma or lymphoproliferative disease.
35. Has a history of congestive heart failure (New York Heart Association class III/IV) or unstable angina.
36. Has renal insufficiency, ascites, pleural effusion, or underlying liver disease.
37. Has any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, GI, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurologic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise participant safety.
38. Has had gastric bypass surgery.
39. Has symptoms of shortness of breath and cough and/or a diagnosis of clinically significant lung disease.
40. Has a history of malignancy, except for the following: adequately-treated nonmetastatic basal cell skin cancer; squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to Screening; and history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to Screening. Participants with a remote history of malignancy (eg, >10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received; this must be discussed with the sponsor on a case-by-case basis prior to enrollment.
41. Has a history of any major neurological disorders, including stroke, central nervous system demyelinating disease, brain tumor, or neurodegenerative disease.
42. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of study drug.
43. Has a history of pre-existing blood dyscrasias, such as bone marrow hypoplasia, leukopenia (WBC count <3 × 10^9/L), thrombocytopenia (platelet count <100 × 10/L), or significant anemia (hemoglobin level <8 g/dL).
44. Has rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
45. Has any of the following laboratory abnormalities during the Screening period:
1. Hemoglobin level <8 g/dL.
2. WBC count <3 x 10^9/L.
3. Lymphocyte count <0.5 x 10^9/L.
4. Platelet count <100 x 10^9/L or >1200 x 10^9/L.
5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 the upper limit of normal (ULN).
6 .Alkaline phosphatase >1.5 x ULN.
7. Renal dysfunction (serum creatinine concentration greater than 1.5 mg per deciliter [133 µmol per liter]) or estimated glomerular filtration rate (eGFR) <50 mL/min/1.73 m^2 at Screening Note: Retesting laboratory values during the screening interval may be considered with consultation from the Medical Monitor.
46. Has a history of high alcohol consumption (more than 7 drinks per week), a history of prior alcohol abuse within 5 years prior to enrollment, has alcoholic liver disease, has withdrawal symptoms, or a history of illicit drug use.
47. Has an active psychiatric problem that, in the investigator's opinion, may interfere with compliance with study procedures.
48. Is unable to attend all the study visits or comply with study procedures.
49. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g, spouse, parent, child, sibling) or may consent under duress.
50. Body mass index is >35.
51. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 6 months after participating in this study; or intending to donate ova during such time period.
52. If male, the participant intends to father a child or donate sperm during the course of this study or for 6 months thereafter.

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Bowel Disease
Open to Enrollment

Clinical Study of the BÜHLMANN fCAL™ ELISA as an Aid in the Differentiation of Inflammatory Bowel Disease From Irritable Bowel Syndrome

The purpose of this study is to confirm the sensitivity and specificity of the BÜHLMANN fCAL™ ELISA as an aid in diagnosis to differentiate between Inflammatory Bowel Disease (IBD; Crohn's Disease (CD), Ulcerative Colitis (UC), or indeterminate colitis) and...

Investigator:
Razvan Arsenescu, MD

Irritable Bowel Syndrome (IBS).

ALP Cal01

Sponsor:
Buhlmann Laboratories AG

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 22 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Sampling Method: Probability Sample

Study Population

100 adult subjects with Inflammatory Bowel Disease or Irritable Bowel Syndrome each have provided a stool sample. In addition, 50 pediatric subjects, age 2 years to 21 years, 25 subjects in each diagnostic group (IBD, IBS) will be enrolled. Recruitment of 120 normal subjects who will provide samples.

Inclusion Criteria:
1. Adults or pediatric patients evaluated by a gastroenterological service for investigation of possible inflammatory intestinal disease or IBS. Patients are referred for sub-specialty evaluation of symptoms such as abdominal pain, diarrhea, altered appetite, weight loss, or anemia.
◦IBD: Eligible subjects will be analyzed as patients with IBD after a confirmed diagnosis of Inflammatory Bowel Disease (CD, UC, or Indeterminate Colitis), based on endoscopy and confirmed by histology of biopsies taken during endoscopy.
◦IBS: Eligible candidate subjects can also include patients who are self-referred with the relevant constellation of complaints. Eligible subjects will be enrolled after having a diagnosis of IBS based on the Rome III criteria confirmed by negative endoscopy including the colon and terminal ileum.
◦other GI Disorders: Eligible subjects will be enrolled after having a diagnosis of a gastrointestinal disorder other than IBD or IBS, confirmed by endoscopy results and other appropriate diagnostic studies.
◦Healthy Controls: Adults (≥22) with no abdominal complaints and no history of IBS, IBD or other chronic intestinal disorder, confirmed by medical history and physical examination at enrolment.
2. Individuals of either gender, ≥22 years of age (adult samples) or 2 to -21 years of age (pediatric samples).
3. IBD patients whose diagnostic endoscopy occurred within the previous month.
4. Individuals able to understand the study and the tasks required, and who sign the Informed Consent Form (adult subjects; ICF) or whose parent/guardian provides consent (ICF) and, if age 7-to-18 years of age, who provide assent (pediatric subjects).

Exclusion Criteria:
1. Individuals unable or unwilling to provide a stool specimen.
2. Individuals with known intestinal cancer, intestinal infection, upper gastrointestinal disease
3. Individuals receiving chemotherapy or systemic immunosuppressive drugs.
4. Individuals who have taken, within the previous 2 weeks, protein pump inhibitors or H2-receptor antagonists.
5. Individuals with previously diagnosed Inflammatory Bowel Disease managed with immunomodulators, 5-ASA (5-aminosalicylic acid) or biologic therapies or who have undergone a surgical resection or diversion procedure.
6. Individuals who have taken NSAIDs (nonsteroidal anti-inflammatory drugs), including aspirin, on 7 or more days during the 2 weeks before providing the sample.

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Bowel Disease
Open to Enrollment

Entyvio (Vedolizumab) Long-term Safety Study: An International Observational Prospective Cohort Study Comparing Vedolizumab to Other Biologic Agents in Patients With Ulcerative Colitis or Crohn's Disease

The purpose of this study is to assess the long-term safety of vedolizumab versus other biologic agents in participants with Ulcerative Colitis (UC) or Crohn's Disease (CD).

Investigator:
Razvan Arsenescu, MD
MLN-0002_401

Sponsor:
Takeda Development Center Americas, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: All
Accepts Healthy Volunteers: No
Sampling Method: Probability Sample

Study Population

Participants with ulcerative colitis (UC) or Crohn's disease (CD) who are initiating Entyvio or another biologic agent. Participants may be biologic-naive or have prior use of a biologic agent

Inclusion Criteria:
1. Signed informed consent, by the participant or a legally acceptable representative.
2. Aged at least 18 years.
3. Initiating vedolizumab or another biologic agent for UC or CD.
4. Signed release form, by the participant or a legally acceptable representative, permitting abstraction of the participant's medical records at Baseline and during participation in the study.

Exclusion Criteria:
1. The participant is enrolled in a clinical trial in which treatment for CD or UC is managed through a protocol.
2. Prior treatment with vedolizumab.
3. Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.

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Brain Cancer
Open to Enrollment

A Phase 2/3 Randomized, Open-Label Study of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC Versus Standard of Care in Subjects Undergoing Planned Resection for Recurrent Glioblastoma or Anaplastic Astrocytoma

This is a multicenter, randomized, open-label phase 2/3 study of Toca 511 and Toca FC versus standard of care that comprises Investigator's choice of single agent chemotherapy (lomustine or temozolomide) or bevacizumab administered to subjects undergoing resection...

Investigator:
Yaron Moshel, MD

for first or second recurrence (including this recurrence) of GBM or AA. Subjects meeting all of the inclusion and none of the exclusion criteria will be randomized prior to surgery in a 1:1 ratio to receive either Toca 511 and Toca FC (Experimental arm, Arm T) or control treatment with one option of standard of care (Arm SOC). Due to the prognostic influence of molecular subgroups such as isocitrate dehydrogenase mutation, the trial will be stratified based on this determination from the primary pathology or subsequent biopsy known locally or otherwise determined centrally.

Tg511-15-01 | PHASE II/III

Sponsor:
Tocagen Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 75 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Subject has given written informed consent
2. Subject is between 18 years old and 75 years old, inclusive
3. Subjects must have histologically proven GBM or AA in first or second recurrence (including this recurrence) or progression following initial definitive multimodal therapy with surgery, temozolomide (unless MGMT promoter unmethylated) and radiation (confirmed by diagnostic biopsy with local pathology review or contrast enhanced MRI). If first recurrence of GBM is documented by MRI, an interval of at least 12 weeks after the end of prior radiation therapy is required unless there is either: i) histopathologic confirmation of recurrent tumor, or ii) new enhancement on MRI outside of the radiotherapy treatment field
4. Subjects must have measurable disease preoperatively, defined as at least 1 contrast enhancing lesion, measuring at least 1 cm in 2 planes (axial, coronal, or sagittal)
5. Subjects must be at least 4 weeks post last dose of temozolomide
6. Prior gamma knife, stereotactic radiosurgery, or other focal high-dose radiotherapy is allowed but the subject must have either histopathologic confirmation of recurrent tumor, or new enhancement on MRI outside of the radiotherapy treatment field
7. Based on the pre operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region
8. IDH mutation status of the primary tumor must be available or tumor samples must be available for pre randomization testing
9. Laboratory values adequate for patient to undergo surgery, including:
◦ Platelet count ≥ 60,000/mm3
◦ Hgb ≥ 10 g/dL
◦ Absolute neutrophil count (ANC) ≥ 1,500/mm3
◦ Absolute lymphocyte count (ALC) ≥ 500/mm3
◦ Adequate liver function, including:
◾ Total bilirubin ≤ 1.5 x ULN (unless has Gilbert's syndrome)
◾ ALT ≤ 2.5 x ULN f. Estimated glomerular filtration rate of at least 50 mL/min by the Cockcroft Gault formula below:
10. Women of childbearing potential (≥12 months of non-therapy-induced amenorrhea or surgically sterile) must have had a negative serum pregnancy test within the past 21 days and must use a birth control method in addition to barrier methods (condoms).
11. Subject or subject's partner is willing to use condoms for 12 months after receiving Toca 511 or until there is no evidence of the virus in his/her blood, whichever is longer.
12. The subject has a KPS ≥ 70
13. The subject is willing and able to abide by the protocol

Exclusion Criteria:
1. History of more than 2 prior recurrences (including this recurrence) of GBM or AA
2. History of other malignancy, unless the patient has been disease free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment
3. Histological confirmed oligodendroglioma or mixed glioma
4. Known 1p/19q co deletion
5. A contrast enhancing brain tumor that is any of the following:
◦ Multi focal (defined as 2 separate areas of contrast enhancement measuring at least 1 cm in 2 planes that are not contiguous on either fluid attenuated inversion recovery (FLAIR) or T2 sequences);
◦ Associated with either diffuse subependymal or leptomeningeal dissemination; or > 5 cm in any dimension
6. The subject has or had any active infection requiring antibiotic, antifungal or antiviral therapy within the past 4 weeks
7. The subject has any bleeding diathesis, or must take anticoagulants, or antiplatelet agents, including nonsteroidal anti inflammatory drugs (NSAIDs), at the time of the scheduled resection that cannot be stopped for surgery
8. The subject is HIV positive
9. The subject has a history of allergy or intolerance to flucytosine
10. The subject has a gastrointestinal disease that would prevent him or her from being able to swallow or absorb flucytosine
11. The subject received cytotoxic chemotherapy within the past 4 weeks (6 weeks for nitrosoureas) of the planned surgery date
12. The subject received any investigational treatment within the past 30 days or prior immunotherapy or antibody therapy within the past 45 days.
13. The subject is breast feeding
14. The subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery or has received the Gliadel® wafer < 30 days from W1D1 (surgery)
15. The subject has received bevacizumab for their disease unless in the context of primary therapy for newly diagnosed glioma
16. For subjects planned to potentially receive bevacizumab, they have no evidence of uncontrolled hypertension (defined as a blood pressure of ≥ 150 mm Hg systolic and/or ≥ 100 mm Hg diastolic on medication) or active GI perforation
17. The subject has received systemic dexamethasone continuously at a dose > 8 mg/day for 8 weeks prior to the date of the screening assessment
18. Severe pulmonary, cardiac or other systemic disease, specifically:
◦ New York Heart Association > Grade 2 congestive heart failure within 6 months prior to study entry, unless asymptomatic and well controlled with medication
◦ Uncontrolled or significant cardiovascular disease, clinically significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation, or Torsades des pointes), clinically significant pulmonary disease (such as ≥ Grade 2 dyspnea, according to CTCAE 4.03)
◦ Subjects who have any other disease, either metabolic or psychological, which as per Investigator assessment may affect the subject's compliance or place the subject at higher risk of potential treatment complications

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Brain Cancer
Closed to Enrollment

A Phase 3 Randomized Double-blind, Controlled Study of ICT-107 With Maintenance Temozolomide (TMZ) in Newly Diagnosed Glioblastoma Following Resection and Concomitant TMZ Chemoradiotherapy

ICT-107 consists of dendritic cells, prepared from autologous mononuclear cells that are pulsed with six synthetic peptides that were derived from tumor associated antigens (TAA) present on glioblastoma tumor cells. This is a Phase 3 study to evaluate ICT-107...

Investigator:
Kurt Jaeckle, MD

in patients with newly diagnosed glioblastoma. Subjects will be randomized to receive standard of care chemoradiation (temozolomide (TMZ) with either ICT-107 or a blinded control. Reinfusion with the pulsed dendritic cells should stimulate cytotoxic T cells to specifically target glioblastoma tumour cells.

ICT-107-301 | PHASE III

Sponsor:
ImmunoCellular Therapeutics, Ltd.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Subjects must understand and sign the study specific informed consent
2. Subjects must be in primary remission
3. Subjects should have < 1 cm3 disease by MRI within the previous 4 weeks (by central read)
4. Subjects must be HLA-A2 positive by central lab
5. Subjects must have adequate renal, hepatic and bone marrow function based on screening laboratory assessments. Baseline hematologic studies and chemistry and coagulation profiles must meet the following criteria:
a. Hemoglobin (Hgb) > 8 g/dL
b. Absolute Neutrophil Count (ANC) > 1000/mm3
c. Platelet count > 100,000/mm3
d. Blood Urea Nitrogen (BUN) < 30 mg/dL
e. Creatinine < 2 mg/dL
f. Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) < 2 x upper limit of normal (ULN)
g. Prothrombin Time (PT) and activated partial thromboplastin time (PTT) ≤ 1.6x unless therapeutically warranted
6. Subjects must use effective contraceptive methods during the study and for three months following the last dose of study product, if of reproductive age and still retain fertility potential.
7. Subjects must have at least one positive DTH skin response (more than 5 mm) to test item challenge prior to randomization.

Exclusion Criteria:
1. Subjects receiving investigational study drug for any indication or immunological-based treatment for any reason (Filgrastim may be used for prevention of severe neutropenia).
2. Subjects with glioblastoma mutated IDH by Immunohistochemistry (IHC)
3. Subjects with concurrent conditions that would jeopardize the safety of the subject or compliance with the protocol.
4. Subjects with a history of chronic or acute hepatitis C or B infection.
5. Subjects require or are likely to require more than a 2-week course of corticosteroids for intercurrent illness. Subjects must have completed the course of corticosteroids at the time of apheresis to meet eligibility.
6. Subjects have any acute infection that requires specific therapy. Acute therapy must have been completed within seven days prior to study enrollment.
7. Subjects with active other malignancy diagnosed in the past 3 years (excepting in situ tumors)
8. Subjects known to be pregnant or nursing.

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Brain Cancer
Open to Enrollment

A Phase II/III Randomized Trial of Veliparib or Placebo in Combination With Adjuvant Temozolomide in Newly Diagnosed Glioblastoma With MGMT Promoter Hypermethylation

This randomized phase II/III trial studies how well temozolomide and veliparib work compared to temozolomide alone in treating patients with newly diagnosed glioblastoma multiforme. Drugs used in chemotherapy, such as temozolomide, work in different ways to...

Investigator:
Kurt Jaeckle, MD

stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether temozolomide is more effective with or without veliparib in treating glioblastoma multiforme.

A071102 | PHASE II/III

Sponsor:
Alliance

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Criteria


Inclusion Criteria:
•Histologic documentation: newly diagnosed World Health Organization (WHO) grade IV intracranial glioblastoma or gliosarcoma; GBM with oligodendroglial features are NOT PERMITTED in this study if they are 1p19q codeleted; sites submitting GBM with oligodendroglial features will be asked to provide results of 1p/19q codeletion status
•Sufficient tissue available for central pathology review and MGMT methylation status evaluation
•Patients who have had a local MGMT testing that is unmethylated are not allowed to participate
•Tumor MGMT promoter hypermethylation determined by central testing at MD Anderson
•Confirmation by central pathology review of WHO grade IV glioblastoma or gliosarcoma
• Absolute neutrophil count (ANC) >= 1500 cells/mm^3 within 14 days prior to study registration
• Platelets >= 100,000 cells/mm^3 within 14 days prior to study registration
• Creatinine =< 1.5 x upper limit of normal (ULN) within 14 days prior to study registration
• Bilirubin =< 1.5 x ULN within 14 days prior to study registration; unless patient has Gilbert's disease
• Alanine aminotransferase (ALT) =< 3 x ULN within 14 days prior to study registration
• Aspartate aminotransferase (AST) =< 3 x ULN within 14 days prior to study registration
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• Measurable disease or non-measurable disease; extent of resection: patients with complete resection, partial resection, or biopsy are eligible
• Progression: patients deemed to have progressive disease based on clinical deterioration after chemoradiation or radiographic progression outside of the radiation field are not eligible; patients deemed to have pseudoprogression are eligible
• Prior treatment:
◦ Must have completed standard radiotherapy and concomitant TMZ therapy as defined and determined by the study oncologist
◦ Besides concomitant TMZ with radiation, no other therapy (neo-adjuvant or adjuvant) can be given prior to study registration, including chemotherapy (also including Gliadel/carmustine [BCNU] wafers), biologics, immunotherapy, radiation therapy; the only exception is the Optune device (NovoTTF-100A), which may be started any time after end of radiation therapy up through the initiation of Cycle 1; intent to use Optune must be declared at registration for stratification
• Not pregnant and not nursing; females of childbearing potential must have negative urine or serum pregnancy test within 7 days of registration but before start of treatment; a female of childbearing potential is a sexually mature female who:
◦ Has not undergone a hysterectomy or bilateral oophorectomy; or
◦ Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
• Concomitant medications: patients receiving anticoagulation should be on stable dose 2 weeks prior to registration
• Comorbid conditions: patients are unable to participate due to the following:
◦ Generalized or partial seizure disorder that is uncontrolled at the time of registration; the definition of controlled generalized seizures is patients must be on a stable dose of anti-seizure medication and without generalized seizures for at least 10 days prior to registration; the definition of controlled partial seizures is patients must be on a stable dose of anti-seizure medication for at least 10 days prior to registration; patients with occasional breakthrough partial seizures are allowed at treating physician's discretion
◦ Grade 3 or 4 thromboembolic disease within 6 months (mo) of registration
◦ Known history of prolonged QT syndrome
• No history of major surgery =< 14 days prior to registration

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Brain Cancer
Open to Enrollment

Phase II Trial of SMO/AKT/NF2 Inhibitors in Progressive Meningiomas With SMO/AKT/NF2 Mutations

This phase II trial studies how well vismodegib and focal adhesion kinase (FAK) inhibitor GSK2256098 work in treating patients with meningioma that is growing, spreading, or getting worse. Vismodegib and FAK inhibitor GSK2256098 may stop the growth of tumor...

Investigator:
Kurt Jaeckle, MD

cells by blocking some of the enzymes needed for cell growth.

A071401 | PHASE II

Sponsor:
Alliance

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Criteria

•Documentation of disease:
◦Histologic documentation: histologically proven intracranial meningioma as documented by central pathology review
◦Molecular documentation: presence of SMO, PTCH1 or NF2 mutation in tumor sample as documented by central laboratory
◦Progressive OR residual disease, as defined by the following:
◾Residual measurable disease: residual measurable disease immediately after surgery without requirement for progression; for grade I disease, progression pre-operatively needs to be documented, with an increase in size of the measurable primary lesion on imaging by 25% or more (bidirectional area); the change must occur between scans separated by no more than 12 months; residual measurable disease will be defined by bidimensionally measurable lesions with clearly defined margins by MRI scans, with a minimum diameter of 10 mm in both dimensions
◾Progressive measurable disease: progression defined as an increase in size of the measurable primary lesion on imaging by 25% or more (bidirectional area); the change must occur between scans separated by no more than 12 months
◾Post radiation patients: patients with measurable and progressive meningioma who have received radiation are potentially eligible, but need to show evidence of progressive disease after completion of radiation; at least 24 weeks must have elapsed from completion of radiation to registration


•Measurable disease: measurable disease is defined by a bidimensionally measurable main lesion on MRI or computed tomography (CT) images (MRI preferred) with clearly defined margins; multifocal disease is allowed
•Prior treatment
◦Prior medical therapy is allowed but not required
◦No limit on number of prior therapies
◦No chemotherapy, other investigational agents within 28 days of study treatment
◦No other concurrent investigational agents or other meningioma-directed therapy (chemotherapy, radiation) while on study
◦For patients treated with external beam radiation, interstitial brachytherapy or radiosurgery, an interval > 24 weeks must have elapsed from completion of radiation therapy to registration
◦Steroid dosing stable for at least 4 days
◦Recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or less toxicity from other agents with exception of alopecia and fatigue
◦No craniotomy within 28 days of registration

•Not pregnant and not nursing:
* A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)

•Eastern Cooperative Oncology Group (ECOG) performance status =< 2
•Patient history:
◦Patients with history of neurofibromatosis (NF) may have other stable central nervous system (CNS) tumors (schwannoma, acoustic neuroma or ependymoma) if lesions have been stable for 6 months
◦No metastatic meningiomas (as defined by extracranial meningiomas) allowed
◦No history of allergic reactions attributed to compounds of similar or biologic composition to assigned study drug
◦No known active hepatitis B or C
◦No current Child Pugh class B or C liver disease
◦No uncontrolled gastric ulcer disease (grade 3 gastric ulcer disease within 28 days of registration)
◦No uncontrolled diabetes defined as a known diabetic with hemoglobin A1C (HBA1C) > 7.5 OR fasting glucose > 140
◦No uncontrolled hypertension defined as blood pressure (BP) > 140/90
◦No abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 28 days prior to registration

•Concomitant medications:
◦Chronic concomitant treatment with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors must discontinue the drug for 14 days prior to registration on the study for patients with NF2 mutation enrolled to GSK2256098
◦Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug 14 days prior to the start of study treatment for patients with NF2 mutation enrolled to GSK2256098

•Absolute neutrophil count (ANC) >= 1,500/mm^3
•Platelet count >= 100,000/mm^3
•Creatinine OR =< 1.5 mg/dl x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance > 45 mL/min
•Urine protein:creatinine ratio (UPC) =< 45 mg/mmol; ONLY APPLICABLE for patients with NF2 mutation (GSK2256098)
•Total bilirubin =< 1.5 x upper limit of normal (ULN); except in case of Gilbert's disease
•Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
•Fasting triglyceride =< 200 mg/dL; ONLY APPLICABLE for patients with NF2 mutation (GSK2256098)
•Fasting cholesterol =< 240 mg/dL; ONLY APPLICABLE for patients with NF2 mutation (GSK2256098)
•Corrected QC interval calculated using Fridericia's formula (QTcF) =< 500 msec; ONLY APPLICABLE for patients with NF2 mutation (GSK2256098)

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Brain Cancer
Open to Enrollment

Phase III Intergroup Study of Radiotherapy With Concomitant and Adjuvant Temozolomide Versus Radiotherapy With Adjuvant PCV Chemotherapy in Patients With 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether...

Investigator:
Kurt Jaeckle, MD

giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.

N0577 | PHASE III

Sponsor:
Alliance

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Pre-Registration Inclusion Criteria:
Central Pathology Review Submission: This review is mandatory prior to registration to confirm eligibility. Patients must be willing to submit tissue samples for mandatory central pathology review submission and deletion status determination. It should be initiated as soon after surgery as possible.

Registration Inclusion Criteria:
1. Age ≥ 18 years
2. Newly diagnosed and ≤ 3 months from surgical diagnosis
3. Histological confirmation of anaplastic glioma (oligodendroglioma, mixed, or astrocytoma [WHO grade 2 or 3] or low grade glioma [WHO grade 2], as determined by pre-registration central pathology review. Note: Mixed gliomas are eligible, regardless of the degree of astrocytic or oligodendrocytic predominance, as long as the tumor is also co-deleted for 1p and 19q.
4. Patients with codeleted low grade gliomas must also be considered "high risk" by clinical criteria utilized in RTOG 9802 and must be either: age ≥ 40 and any surgical therapy or age < 40 and subtotal resection or biopsy.
5. Tumor tissue must show co-deletion for the relevant portions of chromosomes 1p and 19q by FISH analysis, as defined by the testing laboratory.
6. Surgery (partial or gross total resection or biopsy) must be performed ≥ 2 weeks prior to registration. Patient must have recovered from the effects of surgery.
7. The following laboratory values obtained ≤ 21 days prior to registration.
a. Absolute neutrophil count (ANC) ≥ 1500/mm^3
b. Platelet (PLTs) count ≥ 100,000/mm^3
c. Hemoglobin (Hgb) > 9.0g/dL
d. Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
e. Serum glutamic oxaloacetic transaminase (SGOT) aspartate transaminase (AST) ≤ 3 x ULN
f. Creatinine ≤ 1.5 x ULN
8. Negative serum or urine pregnancy test done ≤ 7 days prior to registration for women of childbearing potential only.
9. Willing and able to complete neurocognitive testing without assistance and the Quality of Life (QOL) questionnaires with or without assistance
10. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
11. Provide informed written consent.
12. Willing to return to enrolling institution for follow-up during the Active Monitoring Phase (ie, active treatment and observation portion) of the study
13. Mandatory Tissue Samples for Correlative Research -Patient willing to provide tissue samples for correlative research purposes

Registration Exclusion Criteria:
1. Fetal/Newborn Toxicity: Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects: Pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception during this study and for up to 6 months following the completion of temozolomide treatments.
2. Received any prior surgery, radiation therapy or chemotherapy for any central nervous system (CNS) neoplasm. Note: Patients who have had a prior low grade glioma with or without surgery and who now have anaplastic glioma with no prior radiation or chemotherapy are eligible for the study.
3. Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
4. Concomitant serious immunocompromised status (other than that related to concomitant steroids) that would compromise the safety of the patient on the study.
5. Patients known to be Human Immunodeficiency Virus (HIV) positive and currently receiving retroviral therapy. Note: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for the study.
6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
7. Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
8. Other active malignancy within 5 years of registration. Exceptions:
Non-melanotic skin cancer or carcinoma in situ of the cervix. Note: If there is a history of prior malignancy, the patient must not be receiving other specific treatment (other than hormonal therapy) for their cancer.
9. History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
10. Recent history of hepatitis infection or treating physician determined that the patient would be at significant risk of reactivation of hepatitis.

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Brain Cancer
Open to Enrollment

Randomized Phase II Study: Corticosteroids + Bevacizumab vs. Corticosteroids + Placebo (BEST) for Radionecrosis After Radiosurgery for Brain Metastases

This randomized phase II study aims to investigate whether the addition of bevacizumab to standard corticosteroid therapy results in greater improvement in symptoms and less treatment-induced symptoms compared with standard corticosteroid therapy for patients...

Investigator:
Kurt Jaeckle, MD

with symptomatic brain radionecrosis following radiosurgery. It is hypothesized that the addition of bevacizumab to standard care corticosteroids will reduce treatment-induced toxicities and improve neurologic impairments in patients with brain radionecrosis following radiosurgery for brain metastases.

A221208 | PHASE II

Sponsor:
Alliance

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Pre-Registration Eligibility Criteria:
1. Patients who present with symptomatic brain radionecrosis after they have received radiosurgery for brain metastases from primary solid tumor including but not limited to lung, breast, colorectal cancer but excluding melanoma, choriocarcinoma, renal cell carcinoma or gliomas
2. Patients at institutions that elect to utilize central imaging review to confirm eligibility must be pre-registered prior to submission of these images; images should be submitted as soon as possible after the pre-registration magnetic resonance imaging (MRI) is obtained; turnaround time for this review will be =< 72 business hours after receipt of images by the Imaging and Radiation Oncology Core (IROC)
3. Patients at institutions that elect to confirm eligibility locally may be pre-registered at the same time as they are randomized

Registration/Randomization Eligibility Criteria:

1. A diagnosis of radionecrosis will be based on a clinical onset of symptoms and radiological findings of radionecrosis at 3-24 months following radiosurgery, with or without pathological confirmation.
1.1 'Symptomatic' brain radionecrosis to at least one lesion following radiosurgery treatment for brain metastases where 'symptomatic' is defined as:
1.1.1 New or increasing headache associated with mass effect, sensory or motor abnormality, cognitive changes, speech difficulty, balance or coordination difficulty, cranial nerve deficits
1.1.2 Symptoms are persistent or worsening despite administration of at least dexamethasone 4 mg daily for 1 week
1.2 Clinical eligibility supported by central imaging real-time review. The presence of at least the following conventional MR image characteristic:
1.2.1 Conventional MR - Lesion quotient of < 0.3, where lesion quotient is defined as the proportional value of the maximum axial cross-sectional area of the T2-weighted defined lesion over the maximum axial cross-sectional area of the contrast-enhancing lesion on the T1-weighted post-gadolinium sequence on a comparable axial slice. If the conventional MR findings are not seen, the following dynamic susceptibility-contrast (DSC) MR characteristics may be used to meet eligibility for this study.
1.2.2 DSC MR - The cut-offs below will be based on GRE EPI DSC perfusion images, acquired without using a gadolinium pre-load:
1.2.2.1 Relative cerebral blood volume (rCBV) <1.5 in the enhancing- lesion relative to normal-appearing white matter (NAWM)
1.2.2.2. Percentage of signal recovery (PSR) > 76%, where PSR is determined by comparing the lower signal intensity during passage of the contrast bolus with the post-contrast signal intensity on the signal intensity-time curve
1.2.3 Centers that standardly use PET or MRS to determine a diagnosis of radionecrosis are permitted to use these modalities to assist in their patient selection; however the criteria described for conventional MR and/or DSC should also be met for study eligibility. Both PET and MRS are not mandatory for study eligibility.
2.Prior to start of treatment
2.1 Must have been taking a stable dose of corticosteroids for symptom management for at least 1 week before baseline MRI.
2.2 No systemic therapy within 2 weeks prior to registration or plan for systemic therapy within the first 8 weeks after study registration. The protocol provides a list of 'approved systemic' therapies that are allowed for concurrent use with bevacizumab.
2.3 No bevacizumab ≤ 3 months of study registration.
2.4 Central imaging real-time review (72 hour turn around) to confirm eligibility.
3. Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 14 days prior to registration and confirmation they are not nursing is required.
4. Age ≥ 18 years
5. Karnofsky Performance Status ≥ 60%
6. Required Initial Laboratory Values ≤14 days of registration:
6.1 Absolute Neutrophil Count (ANC) ≥ 1,500/mm^3
6.2 Platelet Count ≥ 100,000/mm3
6.3 Hemoglobin ≥ 10 g/dL*
6.3.1 allowing transfusion or other intervention to achieve this minimum hemoglobin
6.4 BUN < 30 mg/dL
6.5 Creatinine < 1.7 mg/dL
6.6 Bilirubin ≤ 2.0 mg/dL
6.7 ALT ≤ 3.0 x upper limits of normal (ULN)
6.8 AST ≤ 3.0 x ULN
6.9 INR <1.5 x ULN**
6.9.1 unless patients are receiving anti-coagulation therapy. Patients receiving anti-coagulation therapy with an agent such warfarin or heparin are allowed to participate if INR ≤ 3.0.**
6.10 UPC Ratio <0.5 or if ≥ 0.5
6.10.1 24-hour urine protein must be <1000 mg
7. Able to participate in patient-report outcomes (MDASI-BT, DSQ-C, LASA) questionnaires.
Assistance by research personnel is acceptable if participant has disabilities that make reading or writing difficult.
8. No evidence of recent hemorrhage at pre-registration MRI of the brain, however the following are permitted: presence of hemosiderin, resolving hemorrhagic changes related to surgery, and presence of punctate hemorrhage in the tumor.
9. No excess risk of bleeding (any of the following):
9.1 Bleeding diathesis or coagulopathy
9.2 Thrombocytopenia
9.3 Major surgical procedure, open biopsy, or significant traumatic injury within the past 28 days or anticipation of need for major surgical procedure during the course of the study.
9.4 Minor surgical procedures, stereotactic biopsy, fine need aspiration, or core biopsy within the past 7 days.
10. No clinically significant cardiovascular disease.
10.1 No uncontrolled hypertension (systolic blood pressure ≤ 160 mm Hg or diastolic ≤ 100 mm Hg). Patients with hypertension must be adequately controlled with appropriate anti-hypertensive therapy or diet.
10.2 No history of arterial thrombotic events within the past 6 months, including:
10.2.1 transient ischemic attack (TIA)
10.2.2 cerebrovascular accident (CVA)
10.2.3 peripheral arterial thrombus
10.2.4 unstable angina or angina requiring surgical or medial intervention
10.2.5 myocardial infarction (MI)
10.2.6 significant peripheral artery disease (i.e., claudication on less than one block)
10.2.7 significant vascular disease (i.e., aortic aneurysm, history of aortic dissection)
10.3 Patients who have had a deep vein thrombosis or pulmonary embolus within the past 6 months are eligible if they are on stable therapeutic anticoagulation.
10.4 No current New York Heart Association classification II, III, or IV congestive heart failure.
11. No history of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within past 12 months.
12. No central lung metastases with excessive active bleeding.
13. No uncontrolled intercurrent illness including, but not limited to any of the following:
ongoing or active infection requiring IV antibiotics, cardiac arrhythmia, or psychiatric illness and/or social situations that would limit compliance with study requirements.
14. No history of serious non-healing wound, ulcer, or bone fractures.

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Breast Cancer
Open to Enrollment

A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for Node Positive HER2 Negative Breast Cancer: The ABC Trial

This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin...

Investigator:
Michael Kane, MD

is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer.

A011502 | PHASE III

Sponsor:
Alliance

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 69 Years (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Criteria

1.Documentation of Disease - Histologic Documentation: Histologic documentation of women or men with node positive, HER2 negative, anatomic stage II or III breast carcinoma within one year of diagnosis and free of recurrence. If neoadjuvant therapy was received, either initial clinical stage (determined by physical and or radiologic examination) or post-operative pathologic stage can be used for eligibility purposes, with the higher stage determining eligibility. Histologic documentation of node positivity is required.
2.Disease status - Any ER/PgR status allowed.
3.Prior Treatment - Prior adjuvant treatment with chemotherapy and/or endocrine therapy, as determined the treating physician, is allowed. The last dose of chemotherapy or radiation therapy must be at least 60 days prior to study registration. Concurrent hormonal therapy will be allowed.
4.Regular NSAID/aspirin use (defined as ≥ 5 days per week) is allowed if aspirin and/or NSAIDs are stopped for one year prior to study entry and throughout the study period. Participants will be encouraged to use acetaminophen for minor pain and fever.
5.Patients must be enrolled within 1 year after diagnosis.
6.Age > 18 and < 70 years of age.
7.ECOG performance status 0-2.
8.Patients with a prior history of gastric/duodenal ulcers documented on endoscopy can be enrolled as long as the ulcers did not cause bleeding requiring a blood transfusion/major intervention.
9.For patients who are Helicobacter pylori positive, a course of Helicobacter pylori eradication treatment must have been completed.
10.No history of GI bleeding requiring a blood transfusion, endoscopic or operative intervention.
11.No history of any prior stroke (hemorrhagic or ischemic).
12.No concurrent anticoagulation with warfarin or heparin or clopidogrel or oral direct thrombin inhibitors.
13.No history of atrial fibrillation or myocardial infarction.
14.No history of grade 4 hypertension, defined as hypertension resulting in life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit, hypertensive crisis).
15.No chronic (duration >30 days) daily use of oral steroids.
16.No known allergy to aspirin.
17.No prior malignancy of any type within the past 5 years other than breast cancer, basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
18.Concurrent enrollment on a non-chemotherapy treatment trial will be allowed, as long as that trial allows concurrent daily aspirin use.
19.Required Initial Laboratory Values Platelet count ≥ 100,000/mm3

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Breast Cancer
Open to Enrollment

A Randomized, Double-Blind, Phase III Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer - (KEYNOTE-355)

The study will consist of two parts. In Part 1, the safety of pembrolizumab (MK-3475) in combination with one of three different chemotherapies will be assessed in the treatment of locally recurrent inoperable or metastatic triple negative breast cancer (TNBC),...

Investigator:
Bonni Guerin, MD

which has not been previously treated with chemotherapy. In Part 2, the safety and efficacy of pembrolizumab plus chemotherapy will be assessed compared to the safety and efficacy of placebo plus chemotherapy in the treatment of locally recurrent inoperable or metastatic TNBC, which has not been previously treated with chemotherapy.

MK-3475-355 | PHASE III

Sponsor:
Merck, Sharpe & Dohme, Corp.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Has locally recurrent inoperable breast cancer not previously treated with chemotherapy and which cannot be treated with curative intent OR has metastatic breast cancer not previously treated with chemotherapy.
• Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology/college of American Pathologists (ASCO/CAP) guidelines.
• Has completed treatment for Stage I-III breast cancer, if indicated, and ≥6 months elapsed between the completion of treatment with curative intent (e.g., date of primary breast tumor surgery or date of last adjuvant chemotherapy administration, whichever occurred last) and first documented local or distant disease recurrence.
• Has been treated with (neo)adjuvant anthracycline, if they received systemic treatment in the (neo)adjuvant setting, unless anthracycline was contraindicated or not considered the best treatment option for the participant in the opinion of the treating physician.
• Has measurable disease based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by local radiology review.
• Has provided recently or newly obtained core or excisional biopsy from a locally recurrent inoperable or metastatic tumor lesion for central determination of TNBC status and PD-L1 expression, unless contraindicated due to site inaccessibility and/or participant safety concerns.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 10 days prior to the start of study drug.
• Has a life expectancy ≥12 weeks from randomization.
• Demonstrates adequate organ function, within 10 days prior to the start of study drug.
• Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days (or longer as specified by local institutional guidelines) after the last dose of study drug.
• Male participants of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study drug through 120 days (or longer as specified by local institutional guidelines) after the last dose of study drug.

Exclusion Criteria:
• Is currently participating in a clinical study and receiving an investigational agent and/or using an investigational device, or has participated in a clinical study and received an investigational agent and/or used an investigational device within 4 weeks prior to randomization.
• Has not recovered (e.g., to ≤ Grade 1 or to baseline) from AEs due to a previously administered therapy.
• Has neuropathy ≥ Grade 2.
• Has an active autoimmune disease that has required systemic treatment in the past 2 years (e.g., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to randomization.
• Has a known additional malignancy that progressed or required active treatment within the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, and in situ cervical cancer.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they have stable brain metastases and did not receive chemotherapy for metastatic breast cancer.
• Has active, or a history of, pneumonitis requiring treatment with steroids.
• Has active, or a history of, interstitial lung disease.
• Has a known history of active tuberculosis (TB).
• Has an active infection requiring systemic therapy.
• Has a history of Class II-IV congestive heart failure or myocardial infarction within 6 months of randomization.
• Has a known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days (or longer as specified by local institutional guidelines) after the last dose of study drug.
• Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T cell receptor (such as cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137) or has previously participated in Merck pembrolizumab (MK-3475) clinical studies.
• Has a known history of human immunodeficiency virus (HIV).
• Has known active hepatitis B or hepatitis C.
• Has received a live vaccine within 30 days prior to randomization.
• Has a known history of hypersensitivity or allergy to pembrolizumab and any of its components and/or to any of the study chemotherapies (e.g., nab-paclitaxel, paclitaxel, gemcitabine, or carboplatin) and any of their components.
• Is receiving any medication prohibited in combination with study chemotherapies as described in the respective product labels, unless medication was stopped within 7 days prior

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Breast Cancer
Open to Enrollment

Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients With High-Risk, Hormone Receptor-Positive and HER2/Neu Negative Breast Cancer

Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus...

Investigator:
Steven Papish, MD

may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer.This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.

S1207 | PHASE III

Sponsor:
Southwest Oncology Group

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:
•Patients must have a histologically confirmed diagnosis of invasive breast carcinoma with positive estrogen (ER)- and/or progesterone-receptor (PR) status, and negative human epidermal growth factor receptor (HER)2, for whom standard adjuvant endocrine therapy is planned
◦ER and PR positivity must be assessed according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines as either ER or PR ≥ 1% positive nuclear staining
◦HER2 will be determined by immunohistochemistry (IHC) or non-amplified fluorescent in situ hybridization (FISH) or chromogenic in situ hybridization (CISH)
◾If HER2 IHC is 2+, FISH/CISH must be performed and must not be positive (must be a ratio of ≤ 2), but otherwise FISH/CISH is not required if IHC is 0 or 1+ by institutional standards
•Patients must not have inflammatory breast cancer and must not have metastatic breast cancer (stage IV disease); patients with multifocal, multicentric, and synchronous bilateral breast cancers are allowed
◦Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant
◦Multicentric disease is defined as more than one invasive cancer ≥ 2 cm from the largest lesion within the same breast quadrant or more than one lesion in different quadrants
◦Synchronous bilateral disease is defined as invasive breast cancer in both breasts, diagnosed within 30 days of each other
•Patients must be high risk by belonging to one of the following risk groups:
◦Completion of adjuvant chemotherapy and pathologically negative axillary nodes, and a tumor measuring ≥ 2 cm in greatest diameter, and an Oncotype DX® recurrence score (RS) > 25 (completed as standard of care)
◦Completion of adjuvant chemotherapy, and pathologically 1-3 positive axillary lymph nodes, and an Oncotype DX® RS > 25 (screened via S1007 or otherwise)
◦Completion of adjuvant chemotherapy and pathologically 4 or more positive axillary lymph nodes independent of the Oncotype DX® RS in the primary tumor
◦Completion of neoadjuvant chemotherapy and 4 or more positive nodes pathologically determined prior to or after chemotherapy
•Patients must have completed either breast-conserving surgery or total mastectomy, with negative margins and appropriate axillary staging; a negative margin is defined as no evidence of tumor or ductal carcinoma in situ (DCIS) at the line of resection; additional operative procedures may be performed to obtain clear margins
◦Patients who had breast-conserving surgery must have completed whole-breast radiation; use of regional nodal-basin radiation will be at the discretion of the investigator according to institutional guidelines
◦Patients with ≥ 4 positive lymph nodes must have completed breast/chest wall and nodal-basin radiation therapy according to standard-of-care guidelines before randomization; omission of radiation therapy is not allowed in this high-risk population of patients
◦Patients must be registered no sooner than 21 days after completion of radiation therapy and must have recovered (≤ grade 1) from any of the effects of radiation
•Patients must have undergone axillary staging by sentinel-node biopsy or axillary lymph node dissection (ALND)
◦For patients with 1-3 positive lymph nodes, sentinel-node biopsy alone is allowed provided that the patient completed either whole-breast or chest-wall radiation and the primary tumor is < 2 cm
◦All patients with ≥ 4 positive lymph nodes must have completed ALND (with or without prior sentinel-node biopsy)

PATIENT CHARACTERISTICS:
•Peripheral granulocyte count ≥ 1,500/mL
•Hemoglobin ≥ 9 g/dL
•Platelet count ≥ 100,000/mL
•Bilirubin ≤ 1.5 mg/dL (≤ 3.0 mg/dL if due to Gilbert syndrome)
•Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 times institutional upper limit of normal (IULN)
•Alkaline phosphatase ≤ 1.5 times IULN
•Serum creatinine level ≤ IULN
•Fasting cholesterol ≤ 300 mg/dL and triglycerides ≤ 2.5 times IULN; patients may be on lipid-lowering agents to reach these values
•Patients must have a performance status of 0-2 by Zubrod criteria
•Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
•Patients must not have uncontrolled diabetes (defined as a hemoglobin [Hg] A1C > 7% within 28 days prior to registration)
•Patients known to be human immunodeficiency virus (HIV) positive may be enrolled if baseline CD4 count is > 500 cells/mm³ and they are not taking anti-retroviral therapy
•Patients with known hepatitis are not eligible
•Patients must not have any known uncontrolled, underlying pulmonary disease
•Patients must be able to take oral medications
•Patients may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of blinded drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
•Patients must not be pregnant or nursing
•Women/men of reproductive potential must have agreed to use an effective non-hormonal contraceptive method during and for 8 weeks after completion of study therapy
◦In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; corresponding procedures for men include castration, vasectomy, and barrier-contractive devices
◦If at any point a previously celibate patient chooses to become heterosexually active during the protocol therapy, he/she is responsible for beginning contraceptive measures
•No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:
•See Disease Characteristics
•Patients must have completed standard neoadjuvant or adjuvant chemotherapy prior to randomization; completion of chemotherapy will be determined by the treating oncologist, but should include a minimum of 4 courses (a course of weekly paclitaxel is considered 3 doses); patients must be registered within 21 weeks after completion of chemotherapy; patients may have started endocrine therapy at any time after the diagnosis of the current breast cancer
•Patients must not be receiving or planning to receive trastuzumab
•Concurrent bisphosphonate therapy is allowed
•Patients must not have prior exposure to mTOR inhibitors (rapamycin, everolimus, temsirolimus, deforolimus)
•Patients must not have prior treatment with any investigational drug within the preceding 28 days and must not be planning to receive any other investigational drug for the duration of the study
•Patients must not be planning to receive any other anticancer drug for the duration of the study
•Patients must not have an organ allograft or other history of immune compromise; patients must not be receiving chronic, systemic treatment with corticosteroids or other immunosuppressive agent; topical or inhaled corticosteroids are allowed
•Patients must not have received immunization with an attenuated live vaccine (e.g., intranasal influenza, measles, mumps, and rubella [MMR], oral polio, varicella, zoster, yellow fever, and Bacillus Calmette-Guérin [BCG] vaccines) within seven days prior to registration nor have plans to receive such vaccination while on protocol treatment
•Patients must not have taken within 14 days prior to registration, be taking, nor plan to take while on protocol treatment, strong cytochrome P450 3A4 (CYP3A4) inhibitors and/or CYP3A4 inducers

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Breast Cancer
Open to Enrollment

Randomized Double-Blind Placebo Controlled Study of Testosterone in the Adjuvant Treatment of Postmenopausal Women With Aromatase Inhibitor Induced Arthralgias

This randomized phase III trial studies testosterone to see how well it works compared to placebo in treating postmenopausal patients with arthralgia (joint pain) caused by anastrozole or letrozole. Testosterone may help relieve moderate or severe arthralgia...

Investigator:
Jason Incorvati, MD

associated with the use of aromatase inhibitors, such as anastrozole or letrozole.

A221102 | PHASE III

Sponsor:
Alliance

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Age ≥ 18 years
2. Receiving anastrozole (1mg) or letrozole (2.5 mg) orally once a day, for ≥ 21 days prior to registration and plan to continue it throughout the duration of study
3. Body Mass Index (BMI) between 18 and 35 kg/m^2
4. Women who have undergone a total mastectomy or breast conserving surgery for primary breast cancer +/-chemo, +/-radiotherapy.
5. Must have BOTH ER and PR receptor-positive tumors and BOTH must be ≥26% positive. Alternatively, if ER and PR are determined by Allred score, the score needs to be 5 or higher
6. Women who are postmenopausal by surgery, radiotherapy or presence of natural amenorrhea ≥ 12 months
7. ≥ 5/10 arthralgia (in hands, wrist, knees, or hips) while being treated with anastrozole or letrozole which is felt by the patient to be caused by their aromatase inhibitor as defined in the protocol. Note: Patients may, or may not, be taking non-opioid analgesics
8. Ability to complete questionnaire(s) by themselves or with assistance
9. ECOG Performance Status (PS) 0, 1 or 2
10. Willing to provide informed written consent
11. Willing to return to an Alliance enrolling institution for follow-up
12. Willing to provide blood samples for correlative research purposes
13. Laboratory values prior to registration as defined in the protocol:
1. Creatinine ≤1.5 x ULN
2. Hemoglobin > 11 g/dL
3. WBC > 3.0
4. Platelet Count > 100,000
5. SGOT (AST) ≤ 1.5 x ULN

Exclusion Criteria:
1. Presence of residual or recurrent cancer (locally or metastatic)
2. Diabetes mellitus or glucose intolerance, defined as a fasting glucose >125 mg/dL
3. History of coronary artery disease (angina or myocardial infarction)
4. Patients on hormone replacement therapy (HRT) ≤ 4 weeks prior to registration. This includes the use of vaginal estrogen therapy.
5. Known hypersensitivity to any component of testosterone.
6. Prolonged systemic corticosteroid treatment, except for topical applications (e.g. for rash), inhaled sprays (e.g. for obstructive airway diseases), eye drops or local insertion (e.g. intra-articular). Note: Short duration (< 2 weeks) of systemic corticosteroids is allowed (e.g. for chronic obstructive pulmonary disease) but not within 30 days prior to registration.
7. Receiving any other investigational agent
8. History of a deep venous thrombosis or a thromboembolism
9. Concurrent use of the aromatase inhibitor exemestane, as it is structurally similar to an androgen
10. Concurrent radiation therapy or chemotherapy
11. Current or planned use of cyclosporine, anticoagulants, oxphenbutazone, insulin, oral or injectable vitamin D doses over 4,000IU/day, or tamoxifen

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Breast Cancer
Open to Enrollment

Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women With Early Breast Cancer

This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed)...

Investigator:
Michael Kane, MD

have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.

A011401 | PHASE III

Sponsor:
Alliance

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No

Criteria:
1.Documentation of Disease:
1.1 Subjects must have histologically confirmed invasive breast cancer and registration must occur within 12 months after the first histologic diagnosis of invasive breast cancer.
◦A core biopsy interpreted as invasive cancer meets this criterion; if no core biopsy is performed, the date of first histologic diagnosis will be the date of first surgical procedure that identifies invasive cancer (biopsy, lumpectomy or mastectomy).
◦Neoadjuvant subjects should have no evidence of clinical T4 disease prior to chemotherapy and surgery; eligibility for neoadjuvant patients can be defined by either clinical stage prior to therapy or pathologic stage at surgery; if patient is eligible based on either, they are eligible for the study.
◦Bilateral breast carcinoma is allowed provided diagnoses are synchronous - that is, within 3 months of one another - and at least one of the two breast carcinomas meet the eligibility criteria and neither Her-2 positive or inflammatory.
◦No evidence of metastatic disease
1.2 Her-2 negative, defined as:
◦In-situ hybridization (ISH) ratio of < 2.0 (if performed)
◦Immunohistochemistry (IHC) staining of 0-2+ (if performed)
◦Deemed to not be a candidate for Her-2 directed therapy.
1.3 Eligible tumor-node-metastasis (TNM) Stages include:
◦Estrogen receptor (ER) and Progesterone receptor (PR) negative (defined as <1% staining for ER and PR by IHC): T2 or T3 N0, T0-3N1-3. Note: Patients with T1, N1mi disease are NOT eligible.
◦ER and/or PR positive (defined as ≥ 1% staining for ER and/or PR on IHC): T0-3N1-3 or T3N0. Note: Patients with T1-2, N1mi disease are NOT eligible
◦The eligibility of neo-adjuvant subjects can be assessed on the basis of clinical (c)TNM or pathologic (yp)TNM. The same eligible TNM combinations apply; patients may be eligible if they meet eligibility requirements at either time point, as long as they do not have T4 disease prior to therapy.
1.4 No history of invasive breast cancer in 5 years prior to study registration other than the current diagnosis (prior ductal breast carcinoma in situ [DCIS] at any time is acceptable).
1.5 Patients must have had a bilateral mammogram within 12 months prior to registration, unless the initial surgery was a total mastectomy, in which case only a mammogram of the remaining breast is required. (Subjects with bilateral total mastectomies do not require imaging).
1.6 Investigations, including chest X-ray or computed tomography (CT) chest, bone scan (with radiographs of suspicious areas) and abdominal ultrasound or liver scan or CT abdomen have been performed between the first histologic diagnosis and the time of registration as detailed below.
◦Chest X-Ray, 2 view (or Chest CT, or positron emission tomography [PET]/CT) is mandatory
◦Bone scans (with x-rays of abnormal areas) are required only if alanine aminotransferase (ALT), aspartate aminotransferase (AST) or Alkaline Phosphatase is elevated or if there are signs or symptoms of metastatic disease
◦Abdominal imaging is required only if ALT, AST or Alkaline Phosphatase is elevated or if there are signs or symptoms of metastatic disease
2.Prior Treatment
2.1 All adjuvant or neoadjuvant chemotherapy, radiation, and surgery completed at least 21 days prior to registration.
2.2 All triple negative patients must receive chemotherapy of the treating physician's choice.
2.3 ER/PR+ patients must receive chemotherapy (of the treating physician's choice) unless Oncotype Dx or another genomic predictor score indicates that they are at low or intermediate risk of disease recurrence with endocrine therapy alone.
2.4 Patients may have breast reconstruction during protocol participation, but definitive breast cancer surgery must be completed at least 21 days prior to registration.
Concomitant biologic therapy, hormonal therapy, and bisphosphonates are acceptable.
2.5 Surgical margins must be clear of invasive carcinoma. If there is microscopic residual ductal in situ disease present at lumpectomy or total mastectomy margins, further excision is highly recommended. If further excision is not undertaken, the subject may still be entered on study, provided that in addition to breast or chest wall irradiation, a boost to the tumor bed is delivered. In situ lobular disease at the margin is acceptable.
2.6 All subjects (both adjuvant and neoadjuvant) must have sentinel lymph node biopsy and/or axillary lymph node dissection. Sentinel lymph node biopsy alone is allowed in the following instances:
◦Sentinel lymph node biopsy is negative: pN0
◦Sentinel lymph node biopsy is positive for isolated tumor cells only:
pN0 (i+)
◦Clinically node negative, T1-2 tumors with sentinel lymph node biopsy positive in < 2 lymph nodes without matted nodes and undergoing breast conserving surgery and tangential whole breast irradiation, or undergoing mastectomy and chest wall irradiation.
◦For patients who had a positive node prior to neoadjuvant chemotherapy, sentinel node alone is allowed after neoadjuvant therapy if:
◾Sentinel node biopsy is negative after chemotherapy and either at least 2 sentinel nodes were removed or a clip was placed in the involved node prior to treatment.
◾=< 2 lymph nodes are positive for cancer and the patient is participating in A011202
◦All women who undergo breast conserving therapy must receive concomitant radiotherapy. Radiation after mastectomy is to be administered according to prespecified institutional guidelines. Radiation must be completed at least 21 days prior to registration.
◦Patients with hormone receptor positive breast cancer as defined above must receive at least 5 years of adjuvant hormonal therapy in the form of tamoxifen or an aromatase inhibitor, alone or in combination with ovarian suppression. (NOTE: for patients with ER and PR staining in less than 5% of cells, hormonal therapy for at least 5 years is strongly recommended but not required). Hormonal therapy can be initiated prior to or during protocol therapy.
3.Participants must be women
4.Age ≥ 18 years
5.Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
6.Comorbid Conditions
6.1 No history of other malignancy within the past 4 years, except for malignancies with a >95% likelihood of cure (e.g. non-melanoma skin cancer, papillary thyroid cancer, in situ cervical cancer). Patients cannot have metastatic breast or other cancer.
6.2 No diabetes mellitus currently treated with insulin or sulfonylureas.
6.3 No history of serious digestive and/or absorptive problems, including inflammatory bowel disease and chronic diarrhea that preclude adherence to the study diet.
6.4 No history of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility.
6.5 No prior bariatric surgery or planning to undergo this procedure within the next 2 years after study registration.
6.6 No comorbid conditions that would cause life expectancy of less than 5 years.
6.7 No history of psychiatric disorders that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder) or prevent the patient from giving informed consent.
7.Other
7.1 BMI ≥27 kg/m2 documented within 56 days prior to study registration. The most recent BMI obtained must be used for eligibility. If most recent BMI is <27 then the patient is not eligible to enroll.
7.2 Self-reported ability to walk at least 2 blocks (at any pace).
7.3 Not participating in another weight loss, physical activity or dietary intervention clinical trial. Co-enrollment in some trials involving pharmacologic therapy is allowed. Participants in both arms are also allowed to pursue weight loss and physical activity programs on their own, as long as these programs are not provided as part of a clinical trial.
7.4 Able to read and comprehend English. Eligibility is restricted to individuals who can comprehend and read English given that participation in the study will require the ability to read lifestyle intervention materials and communicate with a coach through 42 phone calls over 2 years. The study team plans to make the intervention available in Spanish in the future.

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Cancer
Open to Enrollment

DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors

This clinical trial studies nivolumab and ipilimumab in treating patients with rare tumors. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread.

Investigator:
Missak Haigentz, MD
S1609 | PHASE II

Sponsor:
Southwest Oncology Group

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Patients must have histologically confirmed rare cancer that did not have a match to a molecularly-guided therapy on EAY131 "National Cancer Institute (NCI)-Molecular Analysis for Therapy Choice (MATCH)" protocol or who progressed on molecularly-matched therapy and have no further molecularly-matched treatment recommendations per EAY131, "NCI-MATCH"
• Patients that do not qualify for one of the histologic cohorts may be considered for registration in the "Not Otherwise Categorized" Rare Tumors cohort with confirmation of at least one of the study chairs via email
• Patients that are determined to have a rare cancer with unknown primary site are eligible under cohort #32 (tumor of unknown primary [cancer of unknown primary; CuP]), provided that there is histologic documentation of metastatic malignancy with no discernible primary site identified from histopathologic review, physical exam and associated cross-sectional imaging of the chest, abdomen, and pelvis
• Patients must have progressed following at least one line of standard systemic therapy and there must not be other approved/standard therapy available that has been shown to prolong overall survival (i.e. in a randomized trial against another standard treatment or by comparison to historical controls); patients who cannot receive other standard therapy that has been shown to prolonged survival due to medical issues will be eligible, if other eligibility criteria are met; OR
◦ Patients for whose disease no standard treatment exists that has been shown to prolong overall survival
• Patients must have a diagnostic quality computed tomography (CT) scan or magnetic resonance imaging (MRI), performed within 28 days prior to registration, which demonstrates measurable disease, as defined in RECIST v. 1.1; all disease must be assessed and documented on the S1609 Baseline Tumor Assessment Form
• No other prior malignancy is allowed except for the following:
◦ Adequately managed stage I or II cancer from which the patient is currently in complete remission
◦ Any other cancer from which the patient has been disease free for one year
◦ Adequately managed stage I or II follicular thyroid or prostate cancer is also eligible, wherein patient is not required to be in complete remission
• Patients may have received prior anti-CTLA4 or other anti-PD-1/anti-PD-L1 therapy, not both, provided that it is completed >= 4 weeks prior to registration for monoclonal therapy, >= 8 weeks prior to registration if therapy involved immune-stimulatory monoclonal antibody (mAb)s, and >= 28 days for all other immunotherapy
• Patients who had prior immune-related adverse event (grade 3 or higher immune-related pneumonitis, hepatitis, colitis, endocrinopathy) with prior immunotherapy (e.g. cancer vaccine, cytokine, etc.) are not eligible
• Patients with clinically controlled thyroiditis or pituitary disorders on stable replacement therapy are eligible
• Patients are not eligible if they have had or are planned for solid organ transplant; patients who have received allogeneic hematopoietic stem cell transplant are eligible if:
◦ The transplant occurred at least 90 days prior to registration,
◦ Patient has no prior acute graft versus host disease (GVHD), and
◦ Within 48 hours of registration, patient demonstrates at least 90% engraftment, defined as: absolute neutrophil count (ANC) >= 500 mcl, measured over 3 consecutive days or 1 day with an ANC >= 1,000 mcl, or platelets >= 50,000 mcl measured, wherein the patient did not receive any platelet transfusions within 7 days prior to laboratory assessment
• Patients with autoimmune disease who are otherwise eligible must not have received steroid and immunosuppressive therapy within 28 days prior to registration
• Patients with brain metastases or primary brain tumors must have completed treatment, surgery or radiation therapy >= 28 days prior to registration and have stable disease at time of registration; metastatic brain parenchymal disease must have been treated and patient must be off steroids for 7 days prior to registration; patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to registration
• Patients must not currently be receiving any other investigational agents or any other systemic anti-cancer therapy (including radiation); in event patient recently received any other systemic anti-cancer therapy, patient must be off therapy at least 7 days prior to registration and any therapy-induced toxicity must have recovered to =< grade 1
• Patients must not have prior history of allergy or known hypersensitivity to nivolumab or ipilimumab
• Patients must have a Zubrod performance status of 0-2
• ANC >= 1,000/mcL
• Platelets >= 75,000/mcL
• Hemoglobin >= 8 g/dL
• Total bilirubin =< 2.0 x institutional upper limit of normal (IULN) or for documented/suspected Gilbert's disease, total bilirubin =< 3.0 x IULN
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =< 3 x IULN
• Serum creatinine =< 2.0 x IULN
• Creatinine clearance (CrCl) >= 50 mL/min., as estimated by the Cockcroft and Gault formula; estimated creatinine clearance is based on actual body weight
• Patients must have adequate thyroid function, as evidenced by either thyroid-stimulating hormone (TSH) or, free thyroxine (T4) serum tests demonstrating values within the normal range, within 28 days prior to registration; Note: TSH, with reflex T4 is allowable if per institutional standard; otherwise, both TSH and free-T4 must be obtained
• Patients must have adequate adrenal axis function, as evidenced by adrenocorticotropic hormone (ACTH) values within the normal ranges or cortisol levels within normal ranges (ante meridiem [AM] cortisol higher than the institutional lower limit of normal), within 28 days prior to registration
• Females of childbearing potential must have negative serum or urine pregnancy test 7 days prior to registration and agree to use birth control throughout study and for 23 weeks after completion of protocol therapy; patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
• Men of reproductive potential must have agreed to use birth control throughout the study and for 31 weeks after completion of protocol therapy; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (vasectomy); however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he is responsible for beginning contraceptive measures
• Patients must not have known active hepatitis B virus (HBV) or hepatitis virus (HCV) infection at time of registration; patients with HBV or HCV that have an undetectable viral load, or in the opinion of the treating investigator is well-controlled, are eligible
• Patients who are known to be human immunodeficiency virus (HIV)-positive at registration are eligible at the time of registration:
1. Cluster of differentiation (CD)4+ cell count greater or equal to 250 cells/mm^3
2. If patient is on antiretroviral therapy, there must be minimal interactions or overlapping toxicity of the antiretroviral therapy with the experimental cancer treatment; once daily combinations that use pharmacologic boosters may not be used
3. No history of non-malignancy acquired immunodeficiency syndrome (AIDS)-defining conditions other than historical low CD4+ cell counts
4 .Probable long-term survival with HIV if cancer were not present
• Patients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, immunosuppressive drugs, or corticosteroids with doses higher than prednisone 10mg or equivalent). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Autoimmune diseases include but are not limited to autoimmune hepatitis, inflammatory bowel disease, multiple sclerosis, vasculitis, or glomerulonephritis; patients with well-controlled systemic lupus erythematous or rheumatoid arthritis may be eligible after communication with the study chairs at S1609SC@swog.org; vitiligo, alopecia, hypothyroidism on stable doses of thyroid replacement therapy, psoriasis not requiring systemic therapy within the past 3 years is permitted; short-term steroid premedication for contrast allergy is permitted
• Patients must not have any uncontrolled intercurrent illness including (not limited to): symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] III/IV), unstable angina pectoris or coronary angioplasty, or stenting within 24 weeks prior to registration, unstable cardiac arrhythmia (ongoing cardiac dysrhythmias of NCI Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4 grade >= 2), known psychiatric illness that would limit study compliance, intra-cardiac defibrillators, known cardiac metastases, or abnormal cardiac valve morphology (>= grade 3)
◦ Note: Patients with history of CHF or patients who are deemed at risk because of underlying cardiovascular disease or exposure to cardiotoxic drugs should have an electrocardiogram (EKG) and echocardiogram (ECHO), as clinically indicated, at baseline and at the start of each cycle; patients who have evidence at baseline (or subsequently) of CHF, myocardial infarction (MI), cardiomyopathy, or myositis cardiac evaluation (NYHA I/II) should have additional consult by a cardiologist, including review of EKG, creatine phosphokinase (CPK), troponin, echocardiogram, as clinically indicated
• Patients must have amylase or lipase within =< 1.5 x IULN without symptoms of pancreatitis at registration, within 28 days prior to registration
• Patients must not have symptomatic interstitial lung disease or pneumonitis
• Patients must have fully recovered from any adverse effects of major surgery (to =< grade 1) at least 14 days prior to registration

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Cancer
Open to Enrollment

Molecular Analysis for Therapy Choice (MATCH)

This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists....

Investigator:
Paul Heller, MD

Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.

EAY131 | PHASE II

Sponsor:
Eastern Cooperative Oncology Group

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Women of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to registration; patients that are pregnant or breast feeding are excluded; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
◦ Has not undergone a hysterectomy or bilateral oophorectomy; or
◦ Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
• Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 4 months after completion of study; should a woman become pregnant or suspect while she or her partner is participating in this study, she should inform her treating physician immediately
• Patients must have histologically documented solid tumors or histologically confirmed diagnosis of lymphoma or multiple myeloma requiring therapy and meet one of the following criteria:
◦ Patients must have progressed following at least one line of standard systemic therapy and there must not be other approval/standard therapy available that has been shown to prolong overall survival (i.e. in a randomized trial against another standard treatment or by comparison to historical controls); patients who cannot receive other standard therapy that has been shown to prolong overall survival due to medical issues will be eligible, if other eligibility criteria are met; if the patient is currently receiving therapy, the clinician must have assessed that the current therapy is no longer benefitting the patient prior to enrolling on MATCH, regardless of whether it is considered standard OR
◦ Patients for whose disease no standard treatment exists that has been shown to prolong overall survival
◦ NOTE: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer; in situ cervical cancer; adequately treated stage I or II cancer from which the patient is currently in complete remission; any other cancer from which the patient has been disease-free for 5 years
• Patients must have measurable disease
• Patients must meet one of the following criteria:
◦ Patients must have tumor amenable to image guided or direct vision biopsy and be willing and able to undergo a tumor biopsy for molecular profiling; patients with multiple myeloma other than plasmacytomas are to have a bone marrow aspirate to obtain tumor cells; biopsy must not be considered to be more than minimal risk to the patient
◾ NOTE: Registration to screening steps (Step 0, 2, 4, 6) must occur after stopping prior therapy; there is no specific duration for which patients must be off treatment prior to registration to the relevant screening step (and subsequently, the biopsy), as long as all other eligibility criteria are met OR
◦ Patient will be undergoing a procedure due to medical necessity during which the tissue may be collected
◾ NOTE: Registration to screening steps (Step 0, 2, 4, 6) must occur after stopping prior therapy; there is no specific duration for which patients must be off treatment prior to registration to the relevant screening step (and subsequently, the biopsy), as long as all other eligibility criteria are met OR
◦ Formalin-fixed paraffin-embedded tumor tissue block(s) are available for submission following pre-registration (not applicable for bone marrow aspirate specimens); criteria for the submission of formalin-fixed paraffin-embedded (FFPE) tissue are:
◾ Tissue must have been collected within 6 months prior to pre-registration to Step 0
◾ Patient may receive treatment after tissue collection; however, lack of response must be documented prior to Step 1; the following restrictions apply:
◾ Enrollment onto another investigational study is not permitted
◾ Intervening therapy that constitutes a new, molecularly targeted therapy is not permitted; please note, immunotherapy is not considered molecularly targeted
◾ Continuation of an agent/regimen for which disease progression has been observed prior to biopsy is permitted, including targeted therapy
◾ A new immunotherapy regimen is permitted; but, lack of response must also be documented prior to registration to Step 0
◾ Formalin-fixed paraffin-embedded tumor tissue block(s) must meet the minimum requirements OR
◦ Results from one of the designated outside laboratories indicate a "rare variant" that is an actionable mutation of interest (aMOI) for specific designated rare variant subprotocols; the following requirements apply:
◾ The outside laboratory notified the site that patient may be a potential candidate for MATCH due to a detected "rare variant"
◾ Patients with an applicable "rare variant" must be able to meet the eligibility criteria for the appropriate subprotocols within 4 weeks following entry on the EAY131 Step 0 screening step
◾ Registration to Step 0 must occur after stopping prior systemic anti-cancer therapy; there is no specific duration for which patients must be off treatment prior to registration to Step 0, as long as all eligibility criteria are met
◾ NOTE: Other potential aMOIs that would be eligibility criteria for NON RARE arms, as determined by the above laboratories, are not applicable for direct treatment assignment on MATCH
◾ NOTE: Tumor tissue for the confirmation of "rare variant" by the MATCH assay is to be submitted, preferably from the same time of collection as that evaluated by the designated outside laboratory
• Patient must not require the use of full dose coumarin-derivative anticoagulants such as warfarin; low molecular weight heparin is permitted for prophylactic or therapeutic use; factor X inhibitors are permitted
◦ NOTE: Warfarin may not be started while enrolled in the EAY131 study
◦ Stopping the anticoagulation for biopsy should be per site standard operating procedure (SOP)
• Patients must have Eastern Cooperative Oncology Group (ECOG) performance status =< 1 and a life expectancy of at least 3 months
• Patients must not currently be receiving any other investigational agents
• Patients must not have any uncontrolled intercurrent illness including, but not limited to:
◦ Symptomatic congestive heart failure (New York Heart Association [NYHA] classification of III/IV)
◦ Unstable angina pectoris or coronary angioplasty, or stenting within 6 months prior to registration to Step 0, 2, 4, 6
◦ Cardiac arrhythmia (ongoing cardiac dysrhythmias of National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4 grade >= 2)
◦ Psychiatric illness/social situations that would limit compliance with study requirements
◦ Intra-cardiac defibrillators
◦ Known cardiac metastases
◦ Abnormal cardiac valve morphology (>= grade 2) documented by echocardiogram (ECHO) (as clinically indicated); (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study); subjects with moderate valvular thickening should not be entered on study
◦ NOTE: To receive an agent, patient must not have any uncontrolled intercurrent illness such as ongoing or active infection; patients with infections unlikely to be resolved within 2 weeks following screening should not be considered for the trial
• Patients must be able to swallow tablets or capsules; a patient with any gastrointestinal disease that would impair ability to swallow, retain, or absorb drug is not eligible
• Patients who are human immunodeficiency virus (HIV)-positive are eligible if:
◦ CD4+ cell count greater or equal to 250 cells/mm^3
◦ If patient is on antiretroviral therapy, there must be minimal interactions or overlapping toxicity of the antiretroviral therapy with the experimental cancer treatment; for experimental cancer therapeutics with CYP3A/4 interactions, protease inhibitor therapy is disallowed; suggested regimens to replace protease inhibitor therapy include dolutegravir given with tenofovir/emtricitabine; raltegravir given with tenofovir and emtricitabine; once daily combinations that use pharmacologic boosters may not be used
◦ No history of non-malignancy acquired immune deficiency syndrome (AIDS)-defining conditions other than historical low CD4+ cell counts
◦ Probable long-term survival with HIV if cancer were not present
• Any prior therapy, radiotherapy (except palliative radiation therapy of 30 gray [Gy] or less), or major surgery must have been completed >= 4 weeks prior to start of treatment; all adverse events due to prior therapy have resolved to a grade 1 or better (except alopecia and lymphopenia) by start of treatment; palliative radiation therapy must have been completed at least 2 weeks prior to start of treatment; the radiotherapy must not be to a lesion that is included as measurable disease
◦ NOTE: Prostate cancer patients may continue their luteinizing hormone-releasing hormone (LHRH) agonist
◦ NOTE: Patients may receive non-protocol treatment after biopsy (if clinically indicated) until they receive notification of results; however, lack of response must be documented prior to registration to Step 1; new non-protocol treatment will NOT be permitted as intervening therapy after registration to Step 0; the decision to stop the intervening non-protocol treatment will be left up to the treating physician if patient has an aMOI; however, patients will need to be off such therapy for at least 4 weeks before receiving any MATCH protocol treatment
◦ NOTE: For patients entering the study via a designated outside laboratory, no intervening systemic non-protocol treatment is permitted after Step 0 registration; all other eligibility requirements still apply to these patients, including the washouts for prior therapy noted above in this section, the time restrictions outlined, and the eligibility criteria for the intended subprotocol
• Patients with brain metastases or primary brain tumors must have completed treatment, surgery or radiation therapy >= 4 weeks prior to start of treatment
• Patients must have discontinued steroids >= 1 week prior to registration to Step 0 and remain off steroids thereafter, except as permitted (see below); patients with glioblastoma (GBM) must have been on stable dose of steroids, or be off steroids, for one week prior to registration to treatment (Step 1, 3, 5, 7)
◦ NOTE: The following steroids are permitted (low dose steroid use is defined as prednisone 10 mg daily or less, or bioequivalent dose of other corticosteroid):
◾ Temporary steroid use for computed tomography (CT) imaging in setting of contrast allergy
◾ Low dose steroid use for appetite
◾ Chronic inhaled steroid use
◾ Steroid injections for joint disease
◾ Stable dose of replacement steroid for adrenal insufficiency or low doses for non-malignant disease
◾ Topical steroid
◾ Steroids required to manage toxicity related to study treatment, as described in the subprotocols
◾ Steroids required as pre- or post-chemotherapy medication for acceptable intervening chemotherapy
◾ NOTE: Steroids must be completed alongside last dose of chemotherapy
• Leukocytes >= 3,000/mcL
• Absolute neutrophil count >= 1,500/mcL
• Platelets >= 100,000/mcL
• NOTE: Patients with documented bone marrow involvement by lymphoma are not required to meet the above hematologic parameters, but must have a platelet count of at least 75,000/mcL and neutrophil count of at least 1,000/mcL
• Total bilirubin =< 1.5 X institutional upper limit of normal (ULN) (unless documented Gilbert's syndrome, for which bilirubin =< 3 x institutional ULN is permitted)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional ULN (up to 5 times ULN in presence of liver metastases)
• Creatinine clearance >= 45 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
• Patients must have an electrocardiogram (ECG) within 8 weeks prior to registration to screening step and must meet the following cardiac criteria:
◦ Resting corrected QT interval (QTc) =< 480 msec
◾ NOTE: If the first recorded QTc exceeds 480 msec, two additional, consecutive ECGs are required and must result in a mean resting QTc =< 480 msec; it is recommended that there are 10-minute (+/- 5 minutes) breaks between the ECGs
◦ The following only need to be assessed if the mean QTc > 480 msec
◾ Check potassium and magnesium serum levels
◾ Correct any identified hypokalemia and/or hypomagnesemia and may repeat ECG to confirm exclusion of patient due to QTc
◾ For patients with heart rate (HR) 60-100 beats per minute (bpm), no manual read of QTc is required
◾ For patients with baseline HR < 60 or > 100 bpm, manual read of QT by trained personnel is required, with Fridericia correction applied to determine QTc
◾ Patient must not have hypokalemia (value < institutional lower limit of normal)
◦ No factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval
◾ NOTE: Patient must be taken off prohibited medication prior to registration to the screening step (Step 0, 2, 4, 6) and remain off these medications thereafter, unless permitted on a subprotocol for the management of treatment related toxicity; patient must be off the drug for at least 5 half-lives prior to registration to the treatment step (Step 1, 3, 5, 7); the medication half-life can be found in the package insert for Food and Drug Administration (FDA) approved drugs

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Cardiomyopathy
Closed to Enrollment

A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of GS-6615 on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy

This study will evaluate the effect of GS-6615 on exercise capacity, quality of life, and safety and tolerability of GS-6615 in participants with symptomatic hypertrophic cardiomyopathy (HCM).

Investigator:
Martin Maron, MD
GS-US-361-1157 | PHASE II/III

Sponsor:
Gilead Sciences, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 65 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:
- Established diagnosis of hypertrophic cardiomyopathy defined by standard criteria as a maximal left ventricular wall thickness ≥ 15 mm at initial diagnosis
- Exertional symptoms including at least one of the following:
- New York Heart Association (NYHA) Class ≥ II dyspnea
- Canadian Cardiovascular Society (CCS) Class ≥ II angina
- Screening (baseline) peak VO2 < 80% of predicted for age, sex, and weight
- Ability to perform an upright treadmill cardiopulmonary exercise test (CPET)

Exclusion Criteria:
- Known aortic valve stenosis (moderate or severe)
- Known coronary artery disease
- Left ventricular systolic dysfunction (ejection fraction < 50%)
- Recent septal reduction procedure (ie, surgical myectomy or alcohol septal ablation) within six months prior to screening or such a procedure scheduled to occur during the study

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Chemotherapy Management
Open to Enrollment

A Phase 2, Randomized, Open-Label Study of Infliximab and Lower Exposure Corticosteroids vs Methylprednisolone and Higher Exposure Oral Corticosteroids for the Management of Immune-Related Severe or Persistent Diarrhea in Patients Treated With Yervoy (Ipilimumab) and/or Opdivo (Nivolumab)

The purpose of this study is to compare the effects of Infliximab and oral prednisone with methylprednisolone and oral prednisone in immune related Grade 3-4 diarrhea (= 3 days) or persistent Grade 2 diarrhea (> 5 days) patients who received chemotherapy with...

Investigator:
Eric Whitman, MD

Yervoy and/or Opdivo

CA209-601 | PHASE II

Sponsor:
Bristol-Myers Squibb Company - CT

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Subjects must have melanoma or lung cancer or renal cell carcinoma and received ipilimumab or nivolumab as a single treatment or in combination
• Subject must have NCI common toxicity Grade 3-4 immune-related diarrhea for up to 3 days or persistent Grade 2 diarrhea for more than 5 days
• Subjects must be discontinued from ipilimumab or nivolumab as monotherapy or with the combination regimen
• Subjects must be permanently discontinued from any clinical trial treatment prior to enrollment

Exclusion Criteria:
• Subjects who received other anti Cytotoxic T-lymphocytic antigen (CTLA-4) (non-ipilimumab) or other anti-Programmed death-1 (PD-1) (non-nivolumab) treatment
• Subjects treated with systemic Corticosteroid (CST) within 2 weeks before randomization and subjects treated with infliximab within 7 weeks before randomization
• Subjects with known history of tuberculosis
• Subjects with immunosuppressive disease that require use of systemic steroids or immunosuppressive treatment
• Subjects allergic to infliximab, inactive components of infliximab, murine proteins and methylprednisolone

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Colon Cancer
Open to Enrollment

A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients With Stage 0-III Colon or Rectal Cancer, Phase III - Preventing Adenomas of the Colon With Eflornithine and Sulindac (PACES)

The investigators hypothesize that the combination of eflornithine and sulindac will be effective in reducing a three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon cancer.

Investigator:
Angela Alistar, MD
S0820 | PHASE III

Sponsor:
Alliance

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
•History of Stage 0-III colon or rectal cancer with primary resection 1 year previously
•Post-operative colonoscopy and CT scans of chest, abdomen & pelvis showing no evidence of disease
•Must not have cardiovascular risk factors including unstable angina, history of myocardial infarction, or cerebrovascular accident, coronary artery bypass surgery, or NY Heart Assoc Class III or IV heart failure.
•Patients must not have known uncontrolled hyperlipidemia (defined as LDL-C >/= 190 mg/dL or triglycerides >/= 500 mg/dL within the past 3 years or uncontrolled high blood pressure (systolic blood pressure > 150 mm Hg) within 28 days prior to registration
•At least 30 days from completion of adjuvant chemo and RT.
•Presence of gastroesophageal reflux disease acceptable if controlled with medications
•Not receiving or planning to receive concomitant corticosteroids,nonsteroidal anti-inflammatory drugs(NSAIDs), nor anticoagulants. Maximum aspirin dose
◦100 mg per day or ≤ two 325 mg tablets per week.
•Able to swallow oral medications
•Laboratory: WBC ≥ 4.0 x 103/mcL, platelets ≥ 100,000/mcL and hemoglobin > 11.0 g/dL. Serum bilirubin ≤ 2.0 mg/dL and AST (SGOT) or ALT(SGPT) ≤ 2 x IULN. Serum creatinine ≤ 1.5 x IULN
•Zubrod PS 0-1, 18 years of age or older
•Will not participate in any other clinical trial for the treatment or prevention of cancer unless off protocol treatment, on follow-up phase only
•Offered opportunity to participate in blood specimen banking

Exclusion Criteria:
•History of colon resection > 40 cm
•Mid-low rectal cancer
•Recurrent or metastatic disease
•High cardiovascular risk; Uncontrolled hypertension
•Planned radiation therapy or additional chemotherapy
•Documented history of gastric/duodenal ulcer within last 12 months and/or current treatment or active symptoms of gastric/duodenal ulcer
•Known history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or inflammatory bowel disease
•≥ 30 dB uncorrectable hearing loss for age of any of the five tested frequencies on prestudy audiogram
•Known hypersensitivity to sulindac or excipient byproducts. Previous asthma, urticaria, or allergic-type reaction to aspirin or other NSAIDs
•Significant medical or psychiatric condition that would preclude study completion (8 years)
•No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for > 5 years
•Pregnant or nursing women. Women/men of reproductive potential must agree to use effective contraception

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Colorectal Cancer
Open to Enrollment

A Randomized Phase II Trial to Evaluate the Efficacy of Supportive Therapy With Ginseng for Patients on Treatment With Regorafenib

This is a randomized, multi-center phase II study of ginseng in colorectal cancer patients treated with regorafenib to determine if ginseng will reduce fatigue in this patient population and improve adherence to regorafenib. Ninety (90) subjects will be enrolled...

Investigator:
Angela Alistar, MD

and randomized using a 2:1 allocation, with 60 subjects enrolled in the regorafenib + ginseng group and 30 enrolled in the regorafenib + no ginseng group.

GI14-191 | PHASE II

Sponsor:
Hoosier Cancer Research Network, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Subjects must be able to understand and be willing to sign the written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization for release of personal health information. A signed informed consent form (ICF) must be appropriately obtained prior to the conduct of any trial-specific procedure. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
• Age ≥ 18 years at the time of consent.
• Life expectancy of at least 12 weeks (3 months) as determined by the treating physician.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 28 days prior to registration.
• Histological or pathologically confirmed stage IV adenocarcinoma of the colon.
• Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.
• Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 2 months after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the treating physician or a designated associate. NOTE: Examples of adequate contraception may include but are not limited to a combination of any two of the following: use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods of contraception (condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/ film/cream/vaginal suppository); total abstinence; male/female sterilization
• All subjects must have radiographically assessable disease per RECIST v1.1 obtained by imaging within 28 days prior to registration.
• Must be able to swallow and retain oral medication.
• Subject must be deemed a suitable candidate for regorafenib as per their treating physician.

Exclusion Criteria:
• Subject should not be receiving any agent for fatigue including steroids, megace or opioids. NOTE: Subjects who have a contrast-induced allergy are allowed to receive steroids for their scans.
• Radiotherapy within 2 weeks prior to study registration. Subjects must have recovered from all therapy-related toxicities.
• Prior treatment with regorafenib.
• Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study.
• Congestive heart failure > New York Heart Association (NYHA) class 2: unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months), myocardial infarction less than 6 months before study registration; cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted); uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
• Evidence or history of bleeding diathesis or coagulopathy.
• Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to study registration.
• Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months of study registration.
• Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 3 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (Non-invasive tumor), Tis (Carcinoma in situ) and T1 (Tumor invades lamina propria)].
• Subjects with pheochromocytoma.
• Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
• Ongoing infection > Grade 2 NCI-CTCAE v4.0.
• Metastatic brain or meningeal tumors (symptomatic or asymptomatic).
• Major surgical procedure or significant traumatic injury, as defined by the site investigator, within 28 days before study registration.
• Renal failure requiring hemo- or peritoneal dialysis
• Dehydration Grade > 2 NCI CTCAE v4 within 7 days prior to registration.
• Subjects with seizure disorder currently requiring medication.
• Persistent proteinuria ≥ Grade 3 NCI CTCAE v4.0 as defined as > 3.5 g/24 hours, measured by urine protein: creatinine ratio on a random urine sample.
• Interstitial lung disease with ongoing signs and symptoms at the time of study registration.
• Pleural effusion or ascites that causes respiratory compromise (≥ NCI CTCAE version 4.0 Grade 2 dyspnea).
• History of organ allograft (including corneal transplant).
• Known or suspected allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulations given during the course of this trial.
• Any malabsorption condition which, in the opinion of the treating physician, will affect the absorption of any of the agents used in this study.
• Women who are pregnant or breast-feeding.
• Any condition, which, in the site investigator's opinion, makes the subject unsuitable for trial participation.
• Substance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.
• Treatment with any investigational agent within 28 days prior to registration.

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Cystic Fibrosis
Open to Enrollment

A Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis

This is a first-in-human and proof-of-concept study of VX-445. The study includes 5 parts. Parts A, B, and C will be conducted in healthy subjects. Parts D and E will be conducted in subjects with Cystic Fibrosis (CF) who are homozygous for the F508del mutation...

Investigator:
Stanley Fiel, MD

of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).

VX16-445-001 | PHASE I/II

Sponsor:
Vertex Pharmaceuticals Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes

Key Inclusion Criteria:

Parts A, B, and C:
• Female subjects must be of non-childbearing potential.
• Between the ages of 18 and 55 years, inclusive.
• Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and a total body weight >50 kg

Parts D and E:
• Body weight ≥35 kg.
• Subjects must have an eligible CFTR genotype:
◦ Part D: Heterozygous for F508del and an MF mutation (F/MF)
◦ Part E: Homozygous for F508del (F/F)
• FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height.

Key Exclusion Criteria:

Parts A, B, and C:
• Any condition possibly affecting drug absorption.
• History of febrile illness within 14 days before the first study drug dose.
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Parts D and E:
• History of clinically significant cirrhosis with or without portal hypertension.
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
• Lung infection with organisms associated with a more rapid decline in pulmonary status.
• History of solid organ or hematological transplantation.
Other protocol defined Inclusion/Exclusion criteria may apply.

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Cystic Fibrosis
Open to Enrollment

A Phase 2, Randomized, Parallel-Group, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of CTP-656 With an Open-Label Active Comparator in Patients With Cystic Fibrosis With CFTR Gating Mutations.

This study will evaluate the efficacy and safety of CTP-656 in patients with cystic fibrosis (CF) who have a cystic fibrosis transmembrane conductance regulator (CFTR) gating mutation.

Investigator:
Stanley Fiel, MD
CP656.2001 | PHASE II

Sponsor:
Concert Pharmaceuticals, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• 18 years of age or older
• Has a confirmed diagnosis of CF with at least one allele of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R.
• Has been stable on Kalydeco therapy for at least 3 months prior to screening
• Has FEV1 ≥ 60% of predicted normal for age, sex, and height at screening and baseline (Day 1) assessments
• Weighs at least 40 kg at screening
• Patients of either gender and women of childbearing potential must be willing to use a medically highly effective form of birth control during the treatment period and 30 days after the last dose of study treatment.

Exclusion Criteria:
• Acute upper respiratory infection or lower respiratory infection, pulmonary exacerbation, or changes in therapy within 4 weeks of study treatment
• Uncontrolled type 2 diabetes, or uncontrolled CF-related diabetes
• History of hepatitis C or chronic active hepatitis B infection
• History of pulmonary tuberculosis, non-tuberculosis mycobacterial infections or allergic bronchopulmonary aspergillosis (ABPA) treated during screening or within 2 years prior to screening
• Colonization with B. cenocepacia, B. dolosa, B. multivorans, and/or M. abcessus within 2 years prior to Screening
• Abnormal liver function
• History of abnormal renal function
• History of prolonged QTcF > 450 msec for males or QTcF > 470 msec for females
• History of solid organ or hematological transplantation
• Using any inhibitor or inducer of cytochrome P450/3A during the study or within 30 days of screening
• Women who are pregnant or lactating, or have plans to become pregnant during the study or within 1 month following the last dose

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Cystic Fibrosis
Open to Enrollment

A Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive

This is a Phase 3, randomized, double-blind, ivacaftor-controlled, parallel-group, multicenter study in subjects aged 12 years and older with CF who are heterozygous for the F508del-CFTR mutation and a second CFTR allele with a gating defect that is clinically...

Investigator:
Stanley Fiel, MD

demonstrated to be ivacaftor responsive.

VX14-661-109 | PHASE III

Sponsor:
Vertex Pharmaceuticals Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 12 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Heterozygous for F508del-CFTR mutation and a second CFTR allele with a gating defect that is clinically demonstrated to be ivacaftor responsive
• FEV1 ≥40% and ≤90% of predicted normal for age, sex, and height during screening
• Stable CF disease as judged by the investigator.

Exclusion Criteria:
• History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
• Pregnant and nursing females (females of childbearing potential must have a negative pregnancy test at Screening and Week -4 Visits).
• Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements

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Cystic Fibrosis
Open to Enrollment

A Phase III, Randomized, Double-blind, Placebo-controlled Study of AeroVanc for the Treatment of Persistent Methicillin-resistant Staphylococcus Aureus Lung Infection in Cystic Fibrosis Patients

This study is a multi-center, randomized phase III study to evaluate the clinical effectiveness of AeroVanc in persistent MRSA in patients with Cystic Fibrosis.

Investigator:
Stanley Fiel, MD
SAV005-04 | PHASE III

Sponsor:
Savara Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 6 Years and older (Child, Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Subjects ≥ 6 years of age at time of Informed Consent Form (ICF) or Assent Form signing.
2. Confirmed diagnosis of CF, determined by having clinical features consistent with the CF phenotype, plus one of the following:
1. Positive sweat chloride test (value ≥ 60 mEq/L),
2. Genotype with 2 mutations consistent with CF (ie, a mutation in each of the cystic fibrosis transmembrane conductance regulator [CFTR] genes).
3. Positive sputum culture or a throat swab culture for MRSA at Screening.
4. In addition to the Screening sample, have at least 2 prior sputum or throat swab cultures positive for MRSA, of which at least 1 sample is more than 6 months prior to Screening. At least 50% of all cultures (sputum or throat swab culture) collected over the previous 1 year must have tested positive for MRSA.
5. Forced expiratory volume in 1 second (FEV1) ≥ 30% and ≤ 90% of predicted that is normal for age, gender, race, and height, using the Global Lung Function Initiative (GLI) equation.
6. At least 1 episode of acute pulmonary infection treated with non-maintenance antibiotics within 12 months prior to the Baseline visit. (Initiation of treatment with intermittent inhaled anti-Pseudomonal therapy will not qualify as treatment with non-maintenance antibiotics).
7. If female of childbearing potential, an acceptable method of contraception must be used during the study and must be combined with a negative pregnancy test obtained during Screening; male subjects who are non-sterile (ie, male who has not been sterilized by vasectomy for at least 6 months) must be willing to use an acceptable method of contraception during the study.

For purposes of this study, the Sponsor defines "acceptable methods of contraception" as:
1. Oral birth control pills administered for at least 1 monthly cycle prior to administration of the study drug.
2. A synthetic progestin implanted rod (eg, Implanon®) for at least 1 monthly cycle prior to the study drug administration but not beyond the 4th successive year following insertion.
3. Intrauterine devices (IUDs), inserted by a qualified clinician for at least 1 monthly cycle prior to study drug administration.
4. Medroxyprogesterone acetate (eg, Depo-Provera®) administered for a minimum of 1 monthly cycle prior to administration of the study drug and continuing through 1 month following study completion.
5. Hysterectomy or surgical sterilization.
6. Abstinence.
7. Double barrier method (diaphragm with spermicidal gel or condoms with contraceptive foam).
8. Able and willing to comply with the protocol, including availability for all scheduled study visits and able to perform all techniques necessary to use the AeroVanc inhaler and measure lung function.
9. Agree not to smoke during any part of the clinical trial (Screening visit through end of study).
10. Subjects with a P. aeruginosa co-infection must either be stable on a regular suppression regimen of inhaled antibiotics or must be, in the opinion of the Investigator, stable despite the lack of such treatment.

Exclusion Criteria:
1. Use of anti-MRSA treatments prescribed as maintenance therapy (intravenous [IV] or inhaled treatment within 28 days; oral treatment within 14 days) during the Screening period, prior to the Baseline visit.
2. Use of non-maintenance antibiotic for pulmonary infection or extrapulmonary MRSA infection (IV or inhaled antibiotic within 28 days; oral antibiotic within 14 days) during the Screening period, prior to the Baseline visit.
3. History of previous allergies or sensitivity to vancomycin, or other component(s) of the study drug or placebo except for a history of red-man syndrome.
4. Inability to tolerate inhaled products.
5. First time sputum culture or throat swab culture yielding B. cepacia, or nontuberculous Mycobacteria in the previous 6 months to Screening.
6. History of lung or other solid organ transplantation or currently on the list to receive lung or other solid organ transplantation.
7. Resistance to vancomycin at Screening (vancomycin resistant Staphylococcus aureus [VRSA], or vancomycin intermediate resistant Staphylococcus aureus [VISA], with minimum inhibitory concentration [MIC] ≥ 8 mcg/mL).
8. Oral corticosteroids in doses exceeding 10 mg prednisone per day or 20 mg prednisone every other day, or equipotent doses of other corticosteroids.
9. Changes in antimicrobial, bronchodilator, anti-inflammatory or corticosteroid medications within 14 days prior to the Baseline visit.
10. Abnormal laboratory findings or other findings or medical history at Screening that, in the Investigator's opinion, would compromise the safety of the subject or the quality of the study data.
11. Inability to tolerate inhalation of a short acting beta2 agonist
12. SpO2 <90% at Screening.
13. Changes in physiotherapy technique or physiotherapy scheduled within 1 week of the Baseline visit.
14. Administration of any investigational drug or device within 4 weeks prior to the Screening visit and during the study
15. Female with positive pregnancy test result during Screening, pregnant (or intends to become pregnant), lactating or intends to breastfeed during the study.
16. Renal insufficiency, defined as creatinine clearance < 50 mL/min using the Cockcroft-Gault equation for adults or Schwartz equation for children at the Screening visit.
17. Abnormal liver function, defined as ≥ 4x upper limit of normal (ULN), of serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT), or known cirrhosis at Screening.
18. Diagnosed with clinically significant hearing loss.
19. History of positive result for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).
20. Planned hospitalizations for prophylaxis antibiotic treatment within 28 days prior to Baseline visit or during the double-blind period (Period 1).

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Cystic Fibrosis
Open to Enrollment

Standardized Treatment of Pulmonary Exacerbations II (STOP2)

This randomized, controlled, open-label study is designed to evaluate the efficacy and safety of differing durations of IV treatment, given in the hospital or at home for a pulmonary exacerbation in adult patients with CF.

Investigator:
Rebecca Griffith
STOP2 | PHASE IV

Sponsor:
Cystic Fibrosis Foundation Therapeutics

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Male or female ≥18 years of age at Visit 1
• Documentation of a CF diagnosis
• Enrolled in the Cystic Fibrosis Foundation National Patient Registry (CFFNPR) prior to Visit 1 (US sites only)
• At the time of Visit 1, there is a plan to initiate IV antibiotics for a pulmonary exacerbation
• Performed spirometry at Visit 1 and Visit 2 and willing to perform spirometry at Visit 3
• Completed the CRISS questionnaire at Visit 1 and Visit 2 and willing to complete the Cystic Fibrosis Respiratory Symptoms Diary (CFRSD) questionnaire at Visit 3
• Willing to adhere to a specific treatment duration determined by initial response to treatment and subsequent randomization
• Willing to return for follow up Visit 3
• Written informed consent obtained from the subject or subject's legal representative

Exclusion Criteria:
• Previous randomization in this study
• Treatment with IV antibiotics in the 6 weeks prior to Visit 1
• Admission to the intensive care unit for current pulmonary exacerbation in the two weeks prior to Visit 2, unless admission was due to a desensitization protocol
• Pneumothorax in the two weeks prior to Visit 2
• Primary diagnosis for current hospitalization is unrelated to worsening lower respiratory symptoms (e.g., pulmonary clean out, distal intestinal obstruction syndrome (DIOS), sinusitis)
• Massive hemoptysis defined as > 250 cc in a 24 hour period or 100 cc/day over 4 consecutive days occurring in the two weeks prior to Visit 2
• Current pulmonary exacerbation thought to be due to allergic bronchopulmonary aspergillosis (ABPA)
• At Visit 1, receiving ongoing treatment with a duration of more than 2 weeks with prednisone equivalent to >10mg/day
• History of solid organ transplantation
• Receiving antimicrobial therapy to treat non-tuberculous mycobacterium (e.g., M. abscessus, M. avium complex) in the two weeks prior to Visit 2

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Diabetes
Open to Enrollment

A Multicenter, Randomized, Partial-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus

This is a multicenter, randomized, partial-blinded, five-arm, placebo-controlled study of human plasma-derived alpha1-proteinase inhibitor (alpha1-PI) in children (ages 6-11 years old) and teens/adults (ages 12-35 years old) with new onset Type 1 Diabetes...

Mellitus (T1DM). The purpose of this study is to evaluate the safety and efficacy of four dosing regimens of human plasma-derived alpha1-PI in T1DM.

GTI1302 | PHASE II

Sponsor:
Grifols Inc

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 6 Years to 35 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
•Diagnosis of T1DM according to the ADA criteria.
•Current use of injected insulin therapy and one positive result on testing for any of the following antibodies (If not currently on insulin therapy, must have positive result for at least two of the below antibodies):
◦Anti-islet-cell antibodies (islet cell antigen 512, insulinoma associated protein 2),
◦Anti-glutamic acid decarboxylase antibodies, or
◦Anti-insulin antibodies (unless received insulin therapy for > 7 days).

•Body Mass Index (BMI) ≤ 25 kg/m2 for adults (≥ 20 years of age) OR < 85th percentile in accordance with the Centers for Disease Control BMI assessment for children and teens (2 through 19 years old).

Exclusion Criteria:
•History of or current diabetic retinopathy, neuropathy, or nephropathy.
•Known thrombophilia or history of thrombosis.
•Malignant disease (including malignant melanoma; however, other forms of skin cancer are allowed) within five years of randomization.
•Active Hepatitis A virus, Hepatitis B virus, Hepatitis C virus, or Human Immunodeficiency Virus infection.
•History of anaphylaxis or severe systemic response to any plasma-derived alpha1-PI preparation or other blood product(s).
•Known selective or severe Immunoglobulin A deficiency.
•Elevated liver enzymes (aspartate transaminase, alanine aminotransferase, and alkaline phosphatase) equal to or greater than 2.5 times the upper limit of normal.
•Therapy with exenatide or any other agents that stimulate pancreatic β cell regeneration or insulin secretion, or any antidiabetic agents (oral or parenteral) other than insulin within three months prior to screening.
•Use of omega-3 fatty acid supplements, including fish oil, within seven days prior to screening.
•Current or planned therapy with inhaled insulin, if it becomes available.
•Use of systemic steroids above a stable dose equivalent to 5 mg/day prednisone (e.g., 10 mg every 2 days) within the 4 weeks prior to randomization. It is recommended to maintain the same dose throughout the study.
•Treatment with immunosuppressants or cytostatic agents within 6 months of randomization.

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Diabetes
Open to Enrollment

SIMPONI® to Arrest β-cell Loss in Type 1 Diabetes

The primary purpose of this study is to determine if golimumab can preserve beta-cell function in children and young adults with newly diagnosed Type 1 Diabetes (T1D).

Investigator:
Sunita Cheruvu, MD
CNTO148DML2001 | PHASE II

Sponsor:
Janssen R & D

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 6 Years to 21 Years (Child, Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Be positive for at least 1 of the following diabetes-related autoantibodies obtained at study screening: Glutamic acid decarboxylase (GAD-65), islet antigen 2 (IA-2), zinc transporter 8 (ZnT8), Islet Cell Cytoplasmic Autoantibodies (ICA), or Insulin (if obtained within 10 days of the onset of exogenous insulin therapy)
• Have a peak stimulated C-peptide level greater than or equal to (>=) 0.2 picomole per milliliter (pmol/mL) following a 4-hour Mixed-meal Tolerance Test (MMTT) obtained at study screening
• Be medically stable on the basis of physical examination, medical history, and vital signs performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population
• Females of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) test at screening and a negative urine pregnancy test at the Week 0 visit
• Participants (or their legally acceptable representatives) are willing and able to adhere to requirements, prohibitions, and restrictions specified in this protocol

Exclusion Criteria:
• Has a history of significant renal, vascular, pulmonary, gastrointestinal, neurologic, hematologic, rheumatologic, or psychiatric disease or immune suppression or immune deficiency.
• Has significant cardiovascular disease, including history of myocardial infarction, congestive heart failure, angina, abnormal electrocardiogram or abnormal stress test
• Has active infections, is prone to infections or has chronic, recurrent or opportunistic infectious disease, including but not limited to, chronic renal infection, chronic chest infection (example [eg.], bronchiectasis), sinusitis, recurrent urinary tract infection (eg., recurrent pyelonephritis, chronic cystitis), Pneumocystis carinii, aspergillosis, latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis or an open, draining, or infected non-healing skin wound or ulcer
• Has a clinically active infection with Epstein-Barr virus (EBV) or an EBV viral load >=10,000 copies per 10^6 peripheral blood mononuclear cell (PBMCs) obtained at study screening. Has a clinically active infection with cytomegalovirus (CMV) or a CMV viral load >= 10,000 copies per milliliter (mL) whole blood obtained at study screening
• Current or prior (within 30 days of screening) treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status, including high-dose inhaled, extensive topical, or systemic glucocorticoids
• Has other autoimmune diseases (eg, rheumatoid arthritis [RA], polyarticular juvenile idiopathic arthritis [pJIA], psoriatic arthritis [PsA], ankylosing spondylitis [AS], multiple sclerosis [MS], systemic lupus erythematosus [SLE]) excluding clinically stable autoimmune thyroiditis whether treated or untreated
• Has any of the following tuberculosis [TB] screening criteria: A history of latent or active TB prior to screening (including but not limited to a positive QuantiFERON®-TB Gold test), signs or symptoms suggestive of active TB upon medical history and/or physical examination, recent close contact with a person with known or suspected active TB
• Has known allergies, intolerance and/or hypersensitivity to human immunoglobulin proteins, golimumab or any of its components or its excipients

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Fracture
Open to Enrollment

The Treatment of Type I Open Fractures in Pediatrics: Evaluating the Necessity of Formal Irrigation and Debridement

Open fractures are frequently encountered in orthopaedics. Treatment usually calls for a formal, operative procedure in which the bone is exposed, foreign tissue is debrided and the wound is irrigated. While this is the current standard of care, not all open...

Investigator:
Barbara Minkowitz, MD

fractures are equal. In retrospective studies, centers are reporting less aggressive operative management for open fractures may result in equal results without the time and expense of the operative theater. The investigators propose a prospective, randomized trial of children with type I open fractures to evaluate whether formal operative treatment is necessary. The investigators' hypothesis is that minor open fractures can be safely treated in the emergency room with irrigation, closed reduction and home antibiotics without an increased risk of infection or other complications.

PROOF | PHASE I/II

Sponsor:
Ann & Robert H. Lurie Children's Hospital of Chicago

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 3 Years to 14 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria


Inclusion Criteria:
• open fracture amenable to treatment by closed reduction
• low energy mechanism of injury (e.g., falls from less than 10 feet, bicycle accidents)
• wound less than 1cm in length and the bone not visualized through the skin

Exclusion Criteria:
• open fracture not amenable to treatment by closed reduction
• open fracture that would typically require operative reduction and fixation
• high energy mechanism of injury (e.g., struck by vehicle, motor vehicle accidents, fall from height greater than 10 feet)
• wound greater than 1cm in length
• gross contamination of wound
• open fractures involving hands or feet (the current standard of care to treat open injuries involving hands or feet is only emergency room management)

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Genetics
Open to Enrollment

A Four-Part, Phase 3, Randomized, Double-Blind, Placebo- Controlled, Four-Arm, Discontinuation Study to Evaluate the Efficacy and Safety of Subcutaneous Injections of BMN 165 Self-Administered by Adults With Phenylketonuria (PKU)

The BMN 165 clinical development program has been designed to demonstrate the safety and efficacy of BMN 165 in reducing blood Phe concentrations in adults with PKU.

Investigator:
Darius Adams, MD
165-302 | PHASE III

Sponsor:
BioMarin Pharmaceutical Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 70 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

INCLUSION CRITERIA
- Have completed a prior BMN 165 study (PAL-003 or 165-301) prior to screening
- Have had a stable BMN 165 dose regimen for at least 14 days prior to screening
- Are at least 18 y/o and no older than 70 y/o at screening
- Subjects who are < 18 y/o and are already enrolled into Study 165-301 under Amendment #1 (10JAN2014) may enroll into this study
- Has identified a person who is ≥ 18 y/o who has the neurocognitive and linguistic capacities to comprehend and complete the POMS-Observer rated scale
- Has identified a competent person(s) ≥ 18 y/o who can observe the subject during study drug administration at certain points in the study
- A home healthcare nurse may perform the study drug observations
- Are willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to any research-related procedures; for minors, parent or guardian provides written consent and assent may be requested
- Are willing and able to comply with all study procedures
- For females of childbearing potential, a negative pregnancy test at screening and willing to have additional pregnancy tests during the study
- If sexually active, willing to use two acceptable methods of contraception during and for 4 weeks after the study
- Males post vasectomy for 2 years with no known pregnancies do not need to use any other forms of contraception during the study.
- Females who have been in menopause for at least 2 years, have had a tubal ligation at least 1 year prior to screening, or have had a total hysterectomy do not need to use any other forms of contraception during the study.
- Have received documented approval from a study dietitian confirming that the subject is capable of maintaining their diet
- Have neurocognitive and linguistic capacities to comprehend and answer investigator's prompts for the ADHD-RS Investigator rated instrument and to complete the POMS-Subject rated scale
- If applicable, maintained stable dose of medication for ADHD, depression, anxiety, or other psychiatric disorder ≥8 weeks prior to enrollment and willing to maintain stable dose throughout study unless a change is medically indicated
- General good health, as evidenced by physical examination, clinical laboratory evaluations, and ECG tests at screening

Exclusion Criteria

- Use of any investigational product (except BMN 165) or investigational medical device within 30 days prior to screening or requirement for any investigational agent prior to completion of all scheduled study assessments
- Use of any medication (except BMN 165) intended to treat PKU, including the use of large neutral amino acids, within 2 days prior to the administration of study drug
- Have known hypersensitivity to Dextran® or components of Dextran
- Use or planned use of any injectable drugs containing PEG (except for BMN 165), including medroxyprogesterone injection, within 3 months prior to screening and during study participation
- Current use of levodopa
- A positive test for HIV antibody, hepatitis B surface antigen, or hepatitis C antibody
- A history of organ transplantation or taking chronic immunosuppressive therapy
- A history of substance abuse in the past 12 months or current alcohol or drug abuse
- Current participation in the Kuvan registry study (PKUDOS). Patients may discontinue the PKUDOS registry trial to allow enrollment in this study
- Pregnant or breastfeeding at screening or planning to become pregnant (self or partner) or breastfeed at any time during the study
- Concurrent disease or condition that would interfere with study participation or safety.
- Major surgery planned during the study period
- Any condition that in the view of the investigator, places the subject at high risk of poor treatment compliance or terminating early from the study
- ALT concentration at least 2x the upper limit of normal
- Creatinine at least 1.5x the upper limit of normal

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Genetics
Open to Enrollment

A Phase 3, Open-Label, Randomized, Multi-Center Study to Assess the Safety & Tolerability of an Induction, Titration, and Maintenance Dose Regimen of BMN 165 Self Administered by Adults w/ Phenylketonuria

The BMN 165 clinical development program has been designed to demonstrate the safety and efficacy of BMN 165 in reducing blood Phe concentrations in patients 18 to 70 years old with hyperphenylalaninemia due to PKU. Study BMN 165-301 is a Phase 3, open-label,...

Investigator:
Darius Adams, MD

randomized study designed to further characterize the safety of BMN 165 during two induction, titration, and maintenance dose regimens in adults with PKU who have not had previous exposure to BMN 165 (naive). Subjects will be randomized (1:1) to titrate up to one of two dose regimens. Other key features of this study are the dose regimens chosen for induction and titration; the study duration; self administration of study drug; and the chosen tertiary objectives.

165-301 | PHASE III

Sponsor:
BioMarin Pharmaceutical Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 70 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

INCLUSION CRITERIA

- A current diagnosis of PKU with the following:
Current blood Phe concentration >600 µmol/L at screening and Average blood Phe concentration of >600 µmol/L over the past 6 months (per available data)
- Have no previous exposure to BMN 165
- Are ≥18 and ≤70 years of age at the time of screening
Subjects who are < 18 years of age but are already enrolled into the study may continue to participate
- If taking Kuvan, have a treatment end date ≥14 days prior to Day 1 (ie, first dose of BMN 165)
- Are willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to any research-related procedures
- Are willing and able to comply with all study procedures
- Has identified a person who is ≥ 18 years of age who has the neurocognitive and linguistic capacities to comprehend and complete the POMS-Observer-rated scale
- Has identified a competent person or persons who are ≥ 18 years of age who can observe the subject during study drug administration and for a minimum of 1 hour following administration until dose titration has completed and if needed upon return to dosing after an AE and per investigator determination.
- A home healthcare nurse may perform the study drug observations.
- For females of childbearing potential, must have a negative pregnancy test at screening and be willing to have additional pregnancy tests during the study. (Females are considered not of childbearing potential if they have been in menopause for at least 2 years, have had a tubal ligation at least 1 year prior to screening, or have had a total hysterectomy.)
- If sexually active, must be willing to use 2 acceptable methods of contraception while participating in the study and 4 weeks after the study.
- Males post vasectomy 2 years with no known pregnancies for at least 2 years do not need to use any other forms of birth control during the study.
- Females who have been in menopause for at least 2 years, have had a tubal ligation at least 1 year prior to screening, or have had a total hysterectomy do not need to use any other forms of contraception during the study.
- Have received documented approval from a study dietician confirming that the subject is capable of maintaining their diet in accordance with dietary information presented in the protocol.
- Have neurocognitive and linguistic capacities to comprehend and answer investigator's prompts for the ADHD RS- Investigator rated instrument and to complete the POMS-Subject rated scale.
- If applicable, maintained stable dose of medication for attention deficit hyperactivity disorder (ADHD), depression, anxiety, or other psychiatric disorder for ≥8 weeks prior to enrollment and willing to maintain stable - - Are in generally good health, as evidenced by physical examination, clinical laboratory evaluations and ECG tests performed at screening

EXCLUSION CRITERIA
- Use of any investigational product or investigational medical device within 30 days prior to screening or requirement for any investigational agent prior to completion of all scheduled study assessments.
- Use of any medication that is intended to treat PKU (except Kuvan), including the use of large neutral amino acids, within 2 days prior to administration of study drug Day 1 (first dose of BMN 165). Note: Kuvan treatment must be stopped ≥14 days before Day 1
- Use or planned use of any injectable drugs containing PEG (other than BMN 165), including medroxyprogesterone injection, within 3 months prior to screening and during study participation
- Known hypersensitivity to any components of BMN 165
- Current use of levodopa
- A positive test for HIV antibody, hepatitis B surface antigen, or hepatitis C antibody
- A history of organ transplantation or on chronic immunosuppressive therapy
- A history of substance abuse (as defined by the Diagnostic and Statistical Manual of Mental Disorders [DSM IV]) in the past 12 months or current alcohol or drug abuse
- Current participation in the Kuvan registry study (PKU Demographics, Outcomes and Safety [PKUDOS]). Patients may discontinue the PKUDOS registry trial to allow enrollment in this study
- Pregnant or breastfeeding at screening or planning to become pregnant (self or partner) or breastfeed at any time during the study
- Concurrent disease or condition that would interfere with study participation or safety (eg, history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurological, oncologic, or psychiatric disease)
- Major surgery planned during the study period
- Any condition that, in the view of the investigator, places the subject at high risk of poor treatment compliance or terminating early from the study
- Alanine aminotransferase (ALT) concentration >2 times the upper limit of normal
- Creatinine >1.5 times the upper limit of normal.

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Genetics
Open to Enrollment

CAscade SCreening for Awareness and Detection of Familial Hypercholesterolemia

The CASCADE-FH Registry is a national, multi-center initiative that will track the therapy, clinical outcomes, and patient-reported outcomes over time. The registry represents a collaboration between The Familial Hypercholesterolemia Foundation, the Duke Clinical...

Investigator:
Robert Fishberg, MD

Research Institute, lipid specialists, cardiologists, primary care providers, quality improvement personnel, and patients, all aiming to increase FH awareness, promote optimal disease management, and improve FH outcomes.

CASCADE

Sponsor:
Duke Clinical Research Institute

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Study Population:
Patients diagnosed Familial hypercholesterolemia (FH).

Inclusion Criteria:

Online Patient Enrollment Inclusion Criteria:
• Patients with existing clinical diagnosis of FH;
• Patients with genetic mutation of FH;
• Patients with an initial (pretreatment) LDL level >190 mg/dL or total cholesterol >300 mg/dL;
• Patients currently taking a lipid-lowering medication and have an LDL >124 mg/dL or total cholesterol >195 mg/dL.

Clinic Patient Enrollment Inclusion Criteria:
• Patients with existing clinical diagnosis of FH using one of the three clinical diagnostic (US MedPed Program Criteria, Simon Broome Register Criteria with diagnosis of "Probable", Dutch Lipid Clinic Network Diagnostic Criteria with diagnosis of "Probable")tools for FH; or
• Patients with genetic mutation of FH

Exclusion Criteria:
• Patients will be excluded from participation in the registry when a known medical condition other than FH that is thought to contribute to hyperlipidemia (i.e., untreated hypothyroidism, nephrotic syndrome, cholestasis hypopituitarism).

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Genetics
Open to Enrollment

Fabry Disease Registry

The Fabry Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Fabry disease, irrespective of treatment status. No experimental intervention is involved; patients in...

Investigator:
Darius Adams, MD

the Registry undergo clinical assessments and receive care as determined by the patient's treating physician.

Fabry Registry | PHASE NA

Sponsor:
Genzyme Corporation

Inclusion & Exclusion Criteria:
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Study Population:
All patients with a confirmed diagnosis of Fabry disease are eligible for inclusion in the Registry.

Inclusion Criteria All patients with a confirmed diagnosis of Fabry disease who have signed the informed consent and patient authorization form(s) are eligible for inclusion. Confirmed diagnosis is defined as a documented deficiency in plasma or leukocyte αGAL (alpha-galactosidase) enzyme activity and/or mutation(s) in the gene coding for αGAL.

Exclusion Criteria There are no exclusion criteria in this Registry. Patients are allowed to participate in other clinical studies and may be receiving different therapies to treat their disease; however, enrollment in other clinical studies should be noted on the Registry case report forms (CRFs).

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Genetics
Open to Enrollment

International Collaborative Gaucher Group (ICGG) Gaucher Registry

The ICGG Gaucher Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Gaucher disease, irrespective of treatment status. No experimental intervention is involved; patients...

Investigator:
Darius Adams, MD

in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician.

Gaucher Registry | PHASE NA

Sponsor:
Genzyme Corporation

Inclusion & Exclusion Criteria:
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Inclusion Criteria:
• All patients with a confirmed diagnosis of Gaucher disease are eligible for inclusion in the Registry. Confirmed diagnosis is defined as a documented β-glucocerebrosidase deficiency and/or mutation in the β-glucocerebrosidase gene.
• For all patients, appropriate patient authorization will be obtained.

Exclusion Criteria:
• No exclusion criteria for participation in the ICGG Gaucher Registry.NOTE: Registry participation does not exclude participation in other clinical studies.

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Genetics
Open to Enrollment

Mucopolysaccharidosis I (MPS I) Registry

The Mucopolysaccharidosis I (MPS I) Registry is an ongoing, observational database that tracks the outcomes of patients with MPS I. The data collected by the MPS I Registry will provide information to better characterize the natural history and progression...

Investigator:
Darius Adams, MD

of MPS I as well as the clinical responses of patients receiving enzyme replacement therapy, such as Aldurazyme (Recombinant Human Alpha-L-Iduronidase), or other treatment modalities.

MPS I Registry | PHASE NA

Sponsor:
Genzyme Corporation

Inclusion & Exclusion Criteria:
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Probability Sample

Study Population:
All Patients with MPS I

Inclusion Criteria:
• All patients with a confirmed diagnosis of MPS I are eligible for inclusion. Confirmed diagnosis is defined as: A. documented biochemical evidence of a deficiency in alpha (a)-L-iduronidase enzyme activity and/or B. mutation(s) in the gene coding for a-L-iduronidase, or measurable clinical signs and symptoms of MPS I
• For all patients there should be a completed patient authorization form

Exclusion Criteria:
• No exclusion criteria for participation in the MPS I Registry. NOTE: Registry participation does not exclude participation in other clinical studies.

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Genetics
Open to Enrollment

Pompe Disease Registry

The Pompe Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Pompe disease, irrespective of treatment status. No experimental intervention is involved; patients in...

Investigator:
Darius Adams, MD

the Registry undergo clinical assessments and receive care as determined by the patient's treating physician.

Pompe Registry | PHASE NA

Sponsor:
Genzyme Corporation

Inclusion & Exclusion Criteria:
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Study Population:
Patients diagnosed with Pompe disease

Inclusion Criteria:
• Patient must have a confirmed diagnosis of Pompe disease, documented by GAA(Glucosidase Alpha Acid) enzyme deficiency or GAA gene mutation

Exclusion Criteria:
• There are no exclusion criteria

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Genetics
Open to Enrollment

Utility of PharmacoGenomics for Reducing Adverse Drug Effects

UPGRADE aims to see whether data from Pharmacogenomic Testing (PGx) can help physicians manage patient medication regimens and assess if the testing has an effect on reducing adverse drug reactions, hospitalizations and emergency department visits. The...

Investigator:
Arnold Pallay, MD

way an individual processes a drug is in part determined by their genes, and there is known to be genetic variation between humans in the way drugs are metabolized. The study of the way genes affect a person's response to drugs is known as "Pharmacogenomics."

UPGRADE

Sponsor:
Companion Dx Reference Lab, LLC

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Male and female subjects over the age of 18, receiving at least one medication with metabolism known to depend on genetic allelic variation.

Inclusion Criteria:
- Subject plans to undergo current index PGx testing at the time of enrollment or underwent current index PGx testing within the prior 1-year period, for genes known to influence metabolism of at least one target drug
- Subject is aged ≥18 years
- Subject is able and willing to provide written informed consent
- Subject reveals a history of at least one TDAE or an inadequate therapeutic effect from a target drug over the 12-month period preceding expected receipt of PGx test results
- Subject is not taking an investigational medication or in an interventional trial that would interfere with participation in the registry

Exclusion Criteria:
- Subject is currently hospitalized
- Subject's medical and medication history is unavailable over the 90-day periods preceding and following the receipt of pharmacogenomic test results
- Subject is unable to provide an accurate history due to mental incapacity
- Subject is known to have undergone prior pharmacogenomic testing (exclusive of the current index PGx testing) for genes specific to the target drugs within the 2-year period preceding enrollment and these results have been previously evaluated

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Growth Hormone Deficiency
Open to Enrollment

A Phase 3, Open-label, Randomized, Multicenter, 12 Months, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin - Therapy in Pre-pubertal Children With Growth Hormone Deficiency

This will be an open-label, randomized, multicenter, efficacy and safety study of weekly MOD-4023 compared to daily Genotropin therapy in pre-pubertal children with growth hormone deficiency.

Investigator:
Barbara Cerame, MD
CP-4-006 | PHASE III

Sponsor:
OPKO Biologics Ltd.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 3 Years to 11 Years (Child)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Pre-pubertal children aged ≥3 years , and not yet 11 years for girls or not yet 12 years with either isolated GHD, or GH insufficiency as part of multiple pituitary hormone deficiency.
2. Confirmed diagnosis of GHD by two different GH provocation tests defined as a peak plasma GH level of ≤10 ng/mL,
3. Bone age (BA) is not older than chronological age and should be less than 10 for girls and less than 11 for boys.
4. Without prior exposure to any rhGH therapy (naïve patients).
5. Impaired height velocity defined as:
o Annualized height velocity (HV) below the 25th percentile for CA (HV < -0.7 SDS) and gender according
6. BMI must be within ±2 SDS of mean BMI for the chronological age and sex.
7. Baseline IGF-I level of at least 1 SD below the mean IGF-I level standardized for age and sex (IGF-I SDS ≤-1)
8. Normal calculated GFR
9. Normal 46XX karyotype for girls.

Exclusion Criteria:
1. Children with prior history of leukemia, lymphoma, sarcoma or any other forms of cancer.
2. History of radiation therapy or chemotherapy
3. Malnourished children defined as BMI < -2 SDS for age and sex
4. Children with psychosocial dwarfism
5. Children born small for gestational age (SGA - birth weight and/or birth length <-2 SDS for gestational age)
6. Presence of anti-hGH antibodies at screening
7. Chromosomal abnormalities including Turner's syndrome, Laron syndrome, Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome, SHOX mutations/deletions and skeletal dysplasias.
8. Concomitant administration of other treatments that may have an effect on growth
9. Major medical conditions and/or presence of contraindication to r-hGH treatment.
10. Closed epiphyses
11. Known or suspected HIV-positive patient, or patient with advanced diseases such as AIDS or tuberculosis.
12. Drug, substance, or alcohol abuse.
13. Known hypersensitivity to the components of study medication.
14. Other causes of short stature such as celiac disease, uncontrolled primary hypothyroidism and rickets.

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Growth Hormone Deficiency
Open to Enrollment

A Trial Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency naïve Pre-pubertal Children With Growth Hormone Deficiency

This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with...

Investigator:
Lawrence Silverman, MD

growth hormone deficiency.

NN8640-4172 | PHASE II

Sponsor:
Novo Nordisk Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 2 Years to 10 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Boys: Tanner stage 1 for pubic hair and testis volume below 4 ml , age at least 2 years and 26 weeks and below or equal to 10.0 years at screening
• Girls: Tanner stage 1 for breast development (no palpable glandular breast tissue) and pubic hair, age at least 2 years and 26 weeks and below or equal to 9.0 years at screening
• Confirmed diagnosis of GHD (growth hormone deficiency) within 12 months prior to screening as determined by two different GH (growth hormone) stimulation tests, defined as a peak GH level of below or equal to 7.0 ng/ml. For children with three or more pituitary hormone deficiencies only one GH stimulation test is needed
• No prior exposure to GH therapy and/or IGF-I (insulin-like growth factor I) treatment
• Height of at least 2.0 standard deviations below the mean height for chronological age (CA) and gender according to the standards of Centers for Disease Control and Prevention 2-20 years: Girls/Boys stature-for-age and weight-for-age percentiles CDC at screening
• Annualized height velocity (HV) below the 25th percentile for CA (chronological age) and gender or below -0.7 SD (standard deviation) score for CA and sex, according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months

Exclusion Criteria:
• Any clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing measurements: Chromosomal aneuploidy and significant gene mutations causing medical "syndromes" with short stature, including but not limited to Turner syndrome, Laron syndrome, Noonan syndrome, or absence of GH receptors. Congenital abnormalities (causing skeletal abnormalities), including but not limited to Russell-Silver Syndrome, skeletal dysplasias. Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants
• Children born small for gestational age (SGA - birth weight and/or birth length below-2 SD for gestational age)
• Concomitant administration of other treatments that may have an effect on growth, including but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder (ADHD)
• Prior history or presence of malignancy and/or intracranial tumour

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Growth Hormone Deficiency
Open to Enrollment

An Open-Label, Long-Term Extension Study of the Safety and Efficacy of A Long-acting Human Growth Hormone (VRS-317) in Children with Growth Hormone Deficiency

Protocol 13VR3 is designed as an open-label extension study assessing long-term VRS-317 administration. It is open to subjects completing a Versartis Phase 2 or 3 study in children with growth hormone deficiency. Patients will be monitored for safety throughout...

Investigator:
Lawrence Silverman, MD

their participation in the study. Safety will be monitored by physical examination, inspection of injection sites, vital signs and clinical laboratory determinations. Adverse events (AEs) and concomitant medications will be captured. AEs will be coded using CTCAE.

13VR3 | PHASE II/III

Sponsor:
Versartis, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 3 years to 12 Years
Genders Eligible for Study: Both
Accepts Health Volunteers: No

Inclusion Criteria:
• Completion of a Versartis Phase 2 or Phase 3 clinical study in pediatric patients with GHD
• Willing and able to comply with all study procedures

Exclusion Criteria:
• Withdrawal from a Versartis clinical study in pediatric patients with GHD
• Lack of compliance in a Versartis clinical study in pediatric patients with GHD
• Use of prohibited medications that may alter responses to the test product
• Presence of certain medical condition conditions if condition or treatment of condition may alter response to test product

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Growth Hormone Deficiency
Open to Enrollment

Comparison of VRS-317, A Long-Acting Growth Hormone to Daily rhGH in a Phase 3, Randomized, One-Year, Open-Label, Multicenter, Non-Inferiority Trial in Pre-pubertal Children with Growth Hormone Deficiency

The trial will compare a semi-monthly VRS-317 dosing regimen for non-inferiority of treatment effect against daily injections of rhGH.

Investigator:
Lawrence Silverman, MD
14VR4 | PHASE III

Sponsor:
Versartis, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 3 Years to 11 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
•Chronological Age ≥ 3.0 years and ≤ 10.0 (girls) and ≤ 11.0 (boys).
•Pre-pubertal status: Absent breast development in girls, testicular volume < 4.0 mL in boys.
•Diagnosis of GHD as documented by two or more GH stimulation test results ≤ 10.0 ng/mL.
•Height SD score ≤ -2.0 at screening.
•Weight for Stature ≥ 10th percentile.
•IGF-I SD score ≤ -1.0 at screening.
•Delayed bone age (≥ 6 months).

Exclusion Criteria:
•Prior treatment with any growth promoting agent
•History of or concurrent significant disease (e.g. diabetes, cystic fibrosis, renal insufficiency).
•Chromosomal aneuploidy, significant gene mutations (other than those that cause GHD) or confirmed diagnosis of a named syndrome.
•A diagnosis of Attention Deficit Hyperactivity Disorder.
•Daily use of anti-inflammatory doses of glucocorticoid.
•Prior history of leukemia, lymphoma, sarcoma or cancer.
•Treatment with an investigational drug in the 30 days prior to screening.
•Known allergy to constituents of the study drug formulation.
•Ocular findings suggestive of increased intracranial pressure and/or retinopathy at screening.
•Significant spinal abnormalities including scoliosis, kyphosis and spina bifida variants.
•Significant abnormality in screening laboratory studies

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Head & Neck Cancer
Open to Enrollment

A Phase 1b/2, Open-Label, Multicentre Study Assessing the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of MEDI4736 in Combination With AZD9150 or AZD5069 in Patients With Advanced Solid Malignancies and Subsequently Comparing AZD9150 and AZD5069 Both as Monotherapy and in Combination With MEDI4736 as Second Line Treatment in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

This multicentre, open-label, Phase 1b/2 study is designed as a 2 part study consisting of a dose-escalation Part A and a dose-expansion Part B.

Investigator:
Eric Whitman, MD
D5660C00004 | PHASE I/II

Sponsor:
AstraZeneca

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 130 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Key Inclusion Criteria:
• Male and female patients must be at least 18 years of age.
• Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1.
• Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerised tomography (CT) scan, except lymph nodes which must have minimum short axis size of 15 mm (CT scan slice thickness no greater than 5 mm in both cases). Indicator lesions must not have been previously treated with surgery, radiation therapy, or radiofrequency ablation unless there is documented progression after therapy.
• Has undergone ≤3 previous regimens of cytoreductive therapies including, but not limited to, platinum-based compounds, taxanes, or 5-fluorouracil.
• Adequate organ and marrow function
• Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined in study protocol
• Additional inclusion for part A: Has a histological confirmation of a solid malignancy (other than HCC) that is refractory to standard therapy or for which no standard of care regimen currently exists.
• Additional inclusion for Part B:Has histologically and/or cytologically confirmed SCCHN that is RM and not amendable to curative therapy by surgery or radiation. Squamous cell carcinoma of the head and neck originating from the following sites is eligible: oral cavity, oropharynx, larynx, or hypopharynx. Has at least 1 SCCHN tumour lesion (TL) amenable to biopsy and must have failed, refused, or has been found to be ineligible for least 1 prior platinum-based chemotherapy for RM-SCCHN Additional inclusion criteria for Arms B1 & B2:must have had prior exposure to anti PDL-1 antibody

Key Exclusion Criteria:
• Spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment. - Presently has a second malignancy other than SCCHN, or history of treatment for invasive cancer other than SCCHN in the past 3 years. Exceptions are
• Previously treated in-situ carcinoma (ie, noninvasive)
• Cervical carcinoma stage 1B or less
• Noninvasive basal cell and squamous cell skin carcinoma Radically treated prostate cancer (prostatectomy or radiotherapy) with normal prostate-specific antigen, and not requiring ongoing antiandrogen hormonal therapy
• Patients must have completed any previous cancer-related treatments before enrolment. Any concurrent chemotherapy, radiotherapy, immunotherapy, or biologic, or hormonal therapy for cancer excludes the patient (concurrent use of hormones for noncancer-related conditions [eg, insulin for diabetes and hormone replacement therapy] is acceptable),
• Experiencing CTCAE grade >1 events, experienced immune-related grade ≥3AEs with prior immunotherapy
• Has active or prior autoimmune disease within the past 2 years
• Has active or prior inflammatory bowel disease or primary immunodeficiency
• Undergone an organ transplant that requires use of immunosuppressive treatment
• Abnormalities in rhythm, conduction or morphology of resting 12-lead ECG
• Uncontrolled comorbid conditions
• Received a live attenuated vaccine within 28 days of first study dose, unable to take oral medications
• History of allergic reactions to study compounds or excepients Additional exclusion criteria Part A: Patients with clinically active brain metastases and prior exposure to AZD9150, AZD5069, MEDI4736, or any other anti PD (L)1 antibody.
Additional exclusion criteria Part B: Patients with brain metastases (known or suspected) Additional exclusion criteria Part B: treatment arms B3, B4, B5, and B6: prior exposure to AZD9150, AZD5069, MEDI4736, or any other anti PD (L)1 antibody.

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Head & Neck Cancer
Open to Enrollment

A Phase 1b/3 Multicenter, Randomized, Open-Label Trial of Talimogene Laherparepvec in Combination With Pembrolizumab for the Treatment of Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

A Phase 1b/3 Multicenter, Randomized, Open-label Trial of Talimogene Laherparepvec in combination with Pembrolizumab for the Treatment of Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck.

Investigator:
Eric Whitman, MD
20130232 | PHASE I

Sponsor:
Amgen, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Subject age ≥ 18 years at the time of informed consent.
• Histologically confirmed diagnosis of metastatic or recurrent SCCHN.
• Disease must be unsuitable for curative surgical resection and must not be amenable to curative radiotherapy.
• Disease must have progressed after treatment with a platinum-containing regimen and should be defined as either one of the following:
• Recurrence/progression within 6 months of prior multimodal therapy using platinum
• Disease progression or recurrence after prior platinum therapy in the recurrent or metastatic setting
• Subject must be candidate for intralesional therapy administration.
• Subject must have radiographically measurable disease per RECIST 1.1 ECOG performance status of 0 or 1.
• Adequate organ function determined within 14 days prior to enrollment.
• Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to enrollment.
• Other Inclusion Criteria May Apply

Exclusion Criteria:
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Primary nasopharyngeal carcinoma.
• Subject at risk of airway compromise in the event of post injection tumor swelling/inflammation based on investigator judgment
• Previous treatment with 3 or more systemic regimens given for recurrent and/or History of other malignancy within the past 3 years with the following exceptions:
• Malignancy treated with curative intent and with no known active disease present and has not received chemotherapy for ≤ 3 years before enrollment and felt to be at low risk for recurrence by the treating physician
• Adequately treated non-melanoma skin cancer without evidence of disease at the time of enrollment
• Adequately treated cervical carcinoma in situ without evidence of disease at the time of enrollment
• Adequately treated breast ductal carcinoma in situ without evidence of disease at the time of enrollment
• Prostatic intraepithelial neoplasia without evidence of prostate cancer at the time of enrollment
• Adequately treated superficial or in situ carcinoma of the bladder without evidence of disease at the time of enrollment
• Evidence of active, non-infectious pneumonitis
• History of interstitial lung disease (ILD)
• Prior therapy with talimogene laherparepvec, pembrolizumab, other anti-PD-1, any other antibody or drug specifically targeting T-cell co-stimulation or immune check point pathway
• Prior enrollment and initiation of treatment on any pembrolizumab trial
• History or evidence of active autoimmune disease that has required systemic treatment in past 2 years. Replacement therapy is not considered a form of systemic treatment
• Evidence of clinically significant immunosuppression Active herpetic skin lesions or prior complications of herpetic infection.
• Requires intermittent or chronic treatment with an antiherpetic drug other than intermittent topical use.
• Prior chemotherapy, radiotherapy, biological cancer therapy or major surgery within 28 days prior to enrollment or has not recovered to CTCAE grade 1 or better from adverse event due to cancer therapy administered more than 28 days prior to enrollment.
• Expected to require other cancer therapy while on study with the exception of local palliative radiation treatment to the site of bone and other metastasis.
• Known human immunodeficiency virus (HIV) disease. Has acute or chronic active hepatitis B or C virus infection or received treatment with nucleotide analogs such as those used in the treatment of hepatitis B virus, ribavirin, or interferon alpha within 12 weeks of initiation of study treatment.

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Head & Neck Cancer
Open to Enrollment

A Phase 2 Study to Evaluate the Safety and Efficacy of Cell Transfer Therapy Using Autologous Tumor Infiltrating Lymphocytes (LN-145) Followed by IL-2 in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

Prospective, multicenter, single-arm, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (LN-145) followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative...

Investigator:
Missak Haigentz, MD

regimen for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.

C-145-03 | PHASE II

Sponsor:
Iovance Biotherapeutics, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Must be greater than 18 years of age at the time of consent.
• Must have persistent, recurrent or metastatic HNSCC; histologic documentation of the primary tumor is required via the pathology report.
• Must have had at least 1 prior systemic chemotherapeutic regimen for management of persistent, recurrent or metastatic HNSCC. Patients must not have any curative therapy options, or be intolerant of, or decline standard of care therapy for persistent, recurrent or metastatic disease.
• Any prior therapy directed at the malignant tumor, including radiation therapy, chemotherapy, biologic/targeted agents and immunologic agents must be discontinued at least 21 days prior to tumor resection for preparing TIL therapy.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Patients must be seronegative for the HIV antibody, hepatitis B antigen, and hepatitis C antibody or antigen.
• Female patients of childbearing potential must be willing to practice an approved method of birth control starting at the time of informed consent and for 1 year after the completion of the lymphodepletion regimen.

Exclusion Criteria:
• Patients who are on a systemic steroid therapy (greater than 10 mg of prednisone or equivalent) within 28 days prior to Visit 2.
• Patients who currently have prior therapy-related toxicities greater than Grade 1 according to Common Toxicity Criteria for Adverse Events (CTCAE) v4.03; (see Appendix Section 16.4), except for alopecia or vitiligo prior to enrollment.
• Patients who have had immunotherapy-attributable AE: which led to discontinuation, or have had an ophthalmologic or neurologic AE of any grade, or actively receiving any immunosuppressive agents for the treatment of toxicity related to prior immunotherapy.
• Patients with documented Grade 2 or greater diarrhea or colitis as a result of previous immunotherapy within six months from screening.
• History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or IL-2.
• Patients with active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system.
• Have any form of primary immunodeficiency, such as severe combined immunodeficiency disease or acquired immune deficiency syndrome (AIDS).
• Diagnosis of end-stage renal disorder requiring hemodialysis.
• Patients who have a left ventricular ejection fraction (LVEF) < 45%.
• Patients who have a FEV1 (forced expiratory volume in one second) of less than or equal to 60 % of normal.

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Head & Neck Cancer
Open to Enrollment

A Phase III Randomized, Open-label, Multi-center, Global Study of MEDI4736 in Combination With Tremelimumab Versus Standard of Care in the Treatment of First-line Recurrent or Metastatic Squamous Cell Head and Neck Cancer (SCCHN) Patients

This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior...

Investigator:
Eric Whitman, MD

systemic chemotherapy for recurrent or metastatic disease.

KESTREL | PHASE III

Sponsor:
AstraZeneca

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Age ≥18 years at the time of screening
2. Documented evidence of SCCHN (oral cavity, oropharynx, hypopharynx, or larynx).
3. A fresh tumor biopsy for the purpose of screening or an available archival tumor sample. Tumor lesions used for fresh biopsies should not be the same lesions used as RECIST target lesions, unless there are no other lesions suitable for biopsy.
4. No prior systemic chemotherapy for recurrent or metastatic disease
5. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
6. No prior exposure to immune-mediated therapy,

Exclusion Criteria:
1. Received any systemic therapy for recurrent or metastatic SCCHN
2. Tumor progression or recurrence within 6 months of last dose of platinum therapy in the primary treatment setting
3. Receipt of any radiotherapy or hormonal therapy for cancer treatment within 30 days prior to first dose of study treatment
4. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis, Crohn's disease], diverticulitis

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Headache
Open to Enrollment

A prospective observational registry of patients treated with Ausanil.

This study is an observational study with the primary objective to assess the safety and tolerability of Ausanil in the treatment of primary headache disorders. The secondary objective is to assess headache pain, functional outcome, time loss to headache and...

Investigator:
Seth Stoller, MD

patient satisfaction with Ausanil treatment.

Ausanil

Sponsor:
VR1, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 80 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Study Population: Patients in a Clinical headache practice (outpatient) with a diagnosis of a primary headache disorder.

Inclusion Criteria:
-Men and women aged 18 to 80 years
-Primary Headache disorder as per International Classification of Headache Disorders-11
-Ausanil naive
-Signed dated informed consent
-Females of childbearing potential must be using adequate contraception during study period.
-Willing and able to comply with registry requirements to document headache response

Exclusion Criteria:
-Known allergy to Ausanil or any of its ingredients
-Active bronchial asthma that in the opinion of the investigator would interfere with use of Ausanil
-Nasal obstruction due to any cause or extensive nasal surgery resulting in scarring or other such impact on nasal mucosa that might lead to heightened sensitivity to Ausanil in the opinion of the investigator.
-Pregnant or breast feeding females
-History of addictive behavior
-Any severe or chronic unstable medical or psychiatric condition
-Active nasal infection or inflammation
-Unable or unwilling to provide informed consent
-Suffer from atypical, basilar or hemiplegic migraine that is new onset or unstable.

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Heart Disease
Open to Enrollment

A Phase III, Double-blind, Randomized Placebo-controlled Study to Evaluate the Effects of Dalcetrapib on Cardiovascular (CV) Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome (ACS): The Dal-GenE Trial

A placebo-controlled, randomized, double-blind, parallel group, phase III multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are...

Investigator:
Robert Fishberg, MD

performed. Subject enrollment may begin in the hospital and will continue following release from the hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (4-12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.

DAL-301 | PHASE III

Sponsor:
Dalcor Pharma UK LTD

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 45 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Subjects with the appropriate genetic background and recently hospitalized for ACS (between 4 and 12 weeks following the index event), will be enrolled in this trial.
• AA genotype at variant gene as determined by Genotype Assay testing, conducted at a designated investigational testing site (ITS)
• Clinically stable, ie, free of ischemic symptoms at rest or with minimal exertion for at least 1 week prior to randomization
• Prior to randomization, subject must have evidence of guidelines-based management of LDL-C, at a minimum to include medical and dietary treatment to a target level of LDL-C <100 mg/dl (<2.6 mmol/L).

Exclusion Criteria:
• Females who are pregnant (negative pregnancy test required for all women of child-bearing potential at Visit 2, Day 0) or breast-feeding
• Women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) who are not simultaneously using two effective contraceptive methods, and one of which being a barrier method (diaphragm, cervical cap, male condom, etc.)
• New York Heart Association (NYHA) Class III or IV heart failure
• Last known hemoglobin <10 g/dL
• Index ACS event presumed due to uncontrolled hypertension

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Heart Disease
Open to Enrollment

A Prospective Multicenter Phase III Clinical Evaluation of the Safety and Efficacy of Lumason™/SonoVue® in Subjects Undergoing Pharmacologic Stress Echocardiography With Dobutamine for the Diagnosis of Coronary Artery Disease

The purpose of this study is to assess the safety and efficacy of Lumason-enhanced dobutamine stress echo (DSE) in subjects having a suboptimal left ventricular endocardial border delineation (LV EBD) at rest and who are scheduled for coronary angiography.

Investigator:
Linda Gillam, MD

The purpose of this study is to assess the safety and efficacy of Lumason-enhanced dobutamine stress echo (DSE) in subjects having a suboptimal left ventricular endocardial border delineation (LV EBD) at rest and who are scheduled for coronary angiography.

BR1-141 | PHASE III

Sponsor:
Bracco Diagnostics, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Provides written Informed Consent and is willing to comply with protocol requirements;
• Is at least 18 years of age;
• Has suspected or known CAD and is scheduled to undergo coronary angiography within 6 months after the LUMASON DSE.
• Has undergone a previous echocardiography prior to enrollment; resulting in suboptimal unenhanced images at rest, defined as ≥ 2 suboptimal adjacent segments in any apical view.

Exclusion Criteria:
• Is a pregnant or lactating female. Exclude the possibility of pregnancy:
• By testing on site at the institution (serum or urine βHCG) within 24 hours prior to the start of LUMASON administration(s),
• By surgical history (e.g., tubal ligation or hysterectomy),
• Post menopausal with a minimum 1 year without menses;
• Has any known hypersensitivity to 1 or more ingredients of LUMASON (sulfur hexafluoride or to any components of LUMASON);
• Has any known hypersensitivity to dobutamine;
• Has an ongoing or recent (within the last 30 days) acute myocardial infarction;
• Has known right-to-left, bidirectional or transient cardiac shunt (ruled out with agitated saline study performed before administration of LUMASON);
• Has electrolyte (especially potassium and magnesium) abnormalities;
• Has unstable pulmonary and/or systemic hemodynamic conditions e.g.:
• Decompensated or inadequately controlled congestive heart failure (NYHA Class IV);
• Hypovolemia;
• Uncontrolled hypertension, i.e. resting systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg;
• Unstable angina;
• Acute coronary syndrome;
• Aortic dissection;
• Acute pericarditis,
• Myocarditis, or endocarditis;
• Stenosis of the main left coronary artery;
• Hemodynamically significant outflow obstruction of the left ventricle, including hypertrophic obstructive cardiomyopathy;
• Hemodynamically significant cardiac valvular defect;
• Acute pulmonary embolism;
• Has uncontrolled cardiac arrhythmias;
• Has significant disturbance in conduction;
• Has hypertrophic subaortic stenosis;
• Has an acute illness (e.g., infections, hyperthyroidism, or severe anemia);
• Was previously entered into this study or received an investigational compound within 30 days before admission into this study;
• Has been treated with any other contrast agent either intravascularly or orally within 48 hours of the first LUMASON administration;
• Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or postdose follow-up examinations;

In addition, due to the use of Atropine in subjects who have not reached targeted heart rate with peak dobutamine infusion, subjects with the following will be excluded:
• Glaucoma;
• Pyloric stenosis;
• Prostatic hypertrophy.

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Heart Disease
Open to Enrollment

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of SAR236553/REGN727 on the Occurence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome

To compare the effect of alirocumab with placebo on the occurrence of cardiovascular events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization)...

Investigator:
Robert Fishberg, MD

in patients who have experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and are treated with evidence-based medical and dietary management of dyslipidemia.

EFC11570

Sponsor:
Sanofi US Services Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 40 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion criteria :

Recently (< 52 weeks) hospitalized for ACS.

Exclusion criteria:
•Age < 40 years.
•ACS event occurring more than 52 weeks prior to randomization visit.
•LDL-C likely to be <70 mg/dL (<1.81 mmo/L) with evidence-based medical and dietary management of dyslipidemia.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Heart Disease
Open to Enrollment

Acute Extravascular Defibrillation Study

The main purpose of this clinical study is to collect electrograms from an investigational lead placed in an extravascular space, for development of a future Implantable Cardioverter Defibrillator (ICD) system.

Investigator:
James Slater, MD
ASD2 | PHASE I

Sponsor:
Medtronic, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Subject must be undergoing surgical procedure for approved indications for:
◦ cardiothoracic surgery where a midline sternotomy is planned, or
◦ cardiothoracic surgery where a subxiphoid/paraxiphoid cut for a chest tube is planned, or
◦ VT ablation procedure with epicardial access, or
◦ implant of a subcutaneous ICD (S-ICD®), or implant of a transvenous ICD (single or dual chamber)
• Subject must be willing to provide Informed Consent
• Subject must be ≥ 18 years old

Exclusion Criteria:
• Subject has known hiatus hernia or moderate or worse pectus excavatum
• Subject had previous pericarditis or prior sternotomy
• Subject has known significant Right Ventricle/ Right Ventricular dilation
• Subject has hypertrophic cardiomyopathy
• Subject is pacemaker dependent
• Subject has known skin irritations due to the Covidien Multi-function defibrillation electrode
• Subject is considered to be at high risk for infection(1)
• Subject has Left Ventricular Ejection Fraction < 20% (most recent available LVEF measurement in the last 6 months)
• Subject has New York Heart Association Class IV
• Subject has myocardial infarction within the last 6 weeks
• Subject currently has unstable angina
• Subject has severe aortic stenosis
• Subject at high risk of stroke (2)
• Subject has Chronic Obstructive Pulmonary Disease and is oxygen dependent
• Subject has permanent AF and will not be adequately anticoagulated during the ASD2 Acute Testing procedure (3)
• Subject with an implanted active cardiac or non-cardiac device during the ASD2 Acute Testing procedure (e.g., ICD, S-ICD®, Pacemaker, Neuro stimulator)
• Subject is enrolled in a concurrent study that may confound the results of this study, without documented pre-approval from a Medtronic study manager
• Subject has any medical condition that would limit study participation
• Subject is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within 7 days prior to the ASD2 Acute Testing procedure
• Subject meets exclusion criteria required by local law (e.g. age, breast feeding,etc.)
• Subject is legally incompetent
a. Screening subjects at high risk for infection will be based on the local investigator judgment decision.
b. Subjects who are at high risk for stroke should be screened according to local country guidelines or, in case of their absence, according to ACC/AHA/ESC 2006 Guidelines for High Risk Factors for Stroke (i.e. exclusion of subjects with previous stroke, TIA, or embolism; Mitral stenosis; prosthetic heart valve).
c. Screening will be based on the local investigator judgment decision.

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Heart Disease
Open to Enrollment

Coronary InterventionS in HIgh-Risk PatiEnts Using a Novel Percutaneous Left Ventricular Support Device (SHIELD II)

The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and...

Investigator:
Barry Cohen, MD

depressed left ventricular ejection fraction.

Shield II

Sponsor:
Thoratec Corporation

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 100 Years (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• At least 18 years of age.
• Patient is undergoing elective or urgent high risk PCI procedure and is hemodynamically stable
• Patient is indicated for a revascularization of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft
• A Heart Team that includes a Cardiac Surgeon who has seen the patient, has determined with concurrence of the Cardiac Surgeon member, that high risk PCI is the appropriate therapeutic option
• The presence of complex coronary artery disease (CAD) makes hemodynamic instability resulting from repeat episodes of reversible myocardial ischemia during PCI likely. Complex CAD is defined as:
◦ an ejection fraction of ≤35% AND at least one of the following:
◾intervention of the last patent coronary conduit, OR
◾intervention of an unprotected left main artery OR
◦ an ejection fraction of ≤35% AND intervention on patient presenting with triple vessel disease defined as at least one significant stenosis (at least 50% diameter stenosis on visual assessment) in all three major epicardial territories
• Written, signed, and dated informed consent

Exclusion Criteria:
• Emergency PCI
• Myocardial infarction at baseline
• Cardiac arrest within 24 hours of procedure requiring CPR or defibrillation
• Hemodynamic support with the HeartMate PHP post-PCI is anticipated
• Cardiogenic shock (systolic blood pressure (SBP)) <90 mmHg for >1 hour with either cool clammy skin OR oliguria OR altered sensorium and cardiac index <2.2 L/min/m2)
• Mural thrombus in the left ventricle
• History of aortic valve replacement
• Documented presence of aortic stenosis (orifice area of 1.5cm2 or less)
• Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as 2 or higher)
• Severe peripheral vascular disease
• Abnormalities of the aorta that would preclude surgery, including aneurysms and significant tortuosity or calcifications
• Patient is on hemodialysis
• Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3x upper limit of normal (ULN) or INR (Internationalized Normalized Ratio) ≥2 or lactate dehydrogenase (LDH) > 2.5x ULN.
• Uncorrectable abnormal coagulation parameters (platelet count ≤75000/mm3 or INR ≥2.0 or fibrinogen ≤1.5 g/l)
• Active systemic infection requiring treatment with antibiotics
• Stroke or transient ischemic attack (TIA) within 6 month of procedure
• Any allergy or intolerance to ionic and nonionic contrast media, anticoagulants, or antiplatelet therapy drugs that cannot be adequately premedicated
• Patient is pregnant
• Participation in another clinical study of an investigational drug or device that has not met its primary endpoint

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Heart Disease
Open to Enrollment

Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System

The study is a multi-center, prospective, early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function, provide guidance for future clinical study designs and development efforts of the Edwards...

Investigator:
John Brown, MD

FORMA Tricuspid Transcatheter Repair System.

FORMA

Sponsor:
Edwards Lifesciences LLC

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Clinically significant, symptomatic (NYHA Functional Class II or greater) functional or secondary, tricuspid regurgitation (per applicable guidelines) requiring tricuspid valve repair or replacement as assessed by the Heart Team
2. NYHA Functional Class II or greater or signs of persistent right heart failure despite optimal medical therapy
3. Determined by the 'HEART Team' (a minimum of one Cardiologist, and one Cardiac Surgeon) to be at high surgical risk for tricuspid valve repair or replacement and the benefit-risk analysis supports utilization of the investigational device

Exclusion Criteria:
1. See Protocol

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Heart Disease
Open to Enrollment

Evaluation of Treatment Strategies for Severe CaLcIfic Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug-Eluting StEnts: The ECLIPSE Trial

This trial will evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES).

Investigator:
Jordan Safirstein, MD
ECLIPSE

Sponsor:
Cardiovascular Systems, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

General Inclusion Criteria:
1. Subject is 18 years of age or older.
2. Subject presents with:
1. stable ischemic heart disease or
2. non-ST elevation acute coronary syndrome, or
3. recent (>48 hours) STEMI
3. Subject has signed the Institutional Review Board (IRB) approved ECLIPSE trial Informed Consent Form (ICF) prior to any trial related procedures, per site requirements.
4. Subject agrees to comply with all follow-up visits and trial procedures.

General Exclusion Criteria:
1. Subject has the inability to understand the trial requirements or has a history of non-adherence with medical advice.
2. Subject has a history of any cognitive or mental health status that would interfere with trial participation.
3. Subject is participating in or has plans to participate in any other investigational drug or device trial that has not reached its primary endpoint.
4. Subject is a female who is pregnant and/or breastfeeding or planning to become pregnant within 1-year.
5. Subject is receiving or scheduled to receive chemotherapy within thirty (30) days prior or any time after the index procedure.
6. Subject has a life expectancy of ≤ twelve (12) months.
7. Subject has undergone any prior PCI in the target vessel or its branches within the prior 12 months.
8. Subject has undergone an unsuccessful or complicated PCI procedure within 30 days prior to randomization, including during the index procedure.
9. Any cardiovascular intervention is planned within 1 year post index procedure aside from a potential planned staged PCI as part of the randomized treatment strategy (see staged and multilesion / multivessel procedure section).
10. Subject has experienced an ST-Segment Elevation Myocardial Infarction (STEMI) within 48 hours.
11. Evidence of heart failure by at least one of the following (note - Left Ventricular Ejection Fraction [LVEF] is not required by protocol):
1. Most recent LVEF ≤25%, or
2. Heart failure (NYHA class ≥3 or Killip class ≥2)
12. Planned use of bare metal stent (BMS), bioresorbable scaffold (BRS), non-stent treatment only of the randomized lesion(s).
13. Subject has a known sensitivity to contrast media, which cannot be adequately pre-medicated.
14. Subject has a relative or absolute contraindication to aspirin or all P2Y12 inhibitor agents, or will be unable to take both aspirin and a P2Y12 inhibitor for at least 6 months after PCI (e.g., due to a planned surgical procedure).
15. Subject has a history of a stroke or transient ischemic attack (TIA) within six (6) months, or any permanent neurologic deficit.
16. Subject has a history of bleeding diathesis or coagulopathy or intention to refuse blood transfusion if one should become necessary.
17. Subject is being treated with or will begin treatment with chronic oral anticoagulation (warfarin or NOAC).
18. Subject has evidence of active infection on the day of the index procedure.
19. Subject is not an acceptable candidate for emergent coronary artery bypass graft (CABG).
20. Subject with known allergy to atherectomy lubricant components including soybean oil, egg yolk phospholipids, glycerin and sodium hydroxide.

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Heart Disease
Open to Enrollment

Global Multicenter, Open-label, Randomized, Event-driven, Active-controlled Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement (TAVR) to Optimize Clinical Outcomes

To assess whether a rivaroxaban-based anticoagulation strategy, following successful TAVR, compared to an antiplatelet-based strategy, is superior in reducing death or first thromboembolic events (DTE). To assess whether a rivaroxaban-based strategy, following...

Investigator:
Robert Kipperman, MD

TAVR, compared to an antiplatelet-based strategy, is non-inferior towards primary bleeding events (PBE).

GALILEO | PHASE III

Sponsor:
Bayer HealthCare Pharmaceuticals Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Successful TAVR (Transcatheter Aortic Valve Replacement) of a native aortic valve stenosis
◦ By iliofemoral or subclavian access
◦ With any approved/marketed device

Exclusion Criteria:
• Atrial fibrillation (AF), current or previous, with an ongoing indication for oral anticoagulant treatment
• Any other indication for continued treatment with any oral anticoagulant (OAC)
• Known bleeding diathesis (such as but not limited to active internal bleeding, clinically significant bleeding, platelet count ≤ 50,000/mm3 at screening, hemoglobin level < 8.5 g/dL, active peptic ulcer or known gastrointestinal (GI) bleeding, history of intracranial hemorrhage or subdural hematoma)
• Any indication for dual-antiplatelet therapy (DAPT) for more than 3 months after randomization (such as coronary, carotid or peripheral stent implantation)
• Clinically overt stroke within the last 3 months
• Planned coronary or vascular intervention or major surgery
• Severe renal impairment (eGFR < 30 mL/min/1.73 m2) or on dialysis, or post-TAVR unresolved acute kidney injury with renal dysfunction stage 2 or higher
• Moderate and severe hepatic impairment (Child-Pugh Class B or C) or any hepatic disease associated with coagulopathy

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Heart Disease
Open to Enrollment

'GREAT' Global Registry for Endovascular Aortic Treatment - Outcomes Evaluation

Prospective, observational Registry to obtain data on device performance and clinical outcomes.

Investigator:
Mark Kumar, MD
GREAT

Sponsor:
W.L. Gore & Associates, Inc.

Inclusion & Exclusion Criteria:
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Study Population
Consecutive series of patients who undergo treatment with Gore endovascular aortic products.

Inclusion Criteria:
• Minimum age required by state regulations
• Indication for aortic endovascular stent graft repair
• Signed informed consent

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Heart Disease
Open to Enrollment

Risk Stratification in Older Adults with Acute Myocardial Infarction (SILVER-AMI)

SILVER-AMI is a research study of older persons who are admitted to the hospital with a heart attack. Patients will be interviewed in the hospital and again 6 months later. The researchers will also collect detailed medical record information to understand...

Investigator:

the effect of heart attacks on older persons. The research team at Yale University will use this information to develop a risk model that can be used to help doctors predict recovery. The goal of the study is to help older people in the future make well-informed decisions about their health care during a heart attack.

SILVER-AMI

Sponsor:
National Institute of Health

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 75 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Study Population: Older adults admitted to the hospital with a heart attack

Inclusion Criteria:
1. Age ≥75 years upon admission to the hospital
2. Elevation of cardiac markers within 24 hours of presentation to the hospital
3. Any one of the following:
1. Symptoms of ischemia
2. ECG with ischemic changes
3. Imaging evidence of Infarction
4. Intracoronary thrombus on angiography

Exclusion Criteria:
1. Patient transferred from another hospital with a length of stay >24 hours at the referring hospital.
2. Refused Informed Consent
3. Decisional impairment with no legally authorized representative
4. AMI is secondary to chest trauma
5. AMI is secondary to in-patient procedure or surgery
6. History of heart transplant
7. Non-English speaking
8. Inability to complete interview (e.g. comatose or aphasia)
9. Inability to contact for follow-up (e.g. no access to phone, not living in the country)
10. Currently a prisoner
11. Death prior to enrollment
12. Previously enrolled in SILVER-AMI

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Heart Disease
Open to Enrollment

St. Jude Medical Product Longevity and Performance (SCORE) Registry

SCORE is an active, prospective, non-randomized, multi-center outcome-oriented registry of patients implanted with St Jude Medical (SJM) market-released cardiac rhythm management (CRM) products. This registry will be conducted in the United States (US). The...

Investigator:
Stephen Winters, MD

primary purpose of the registry is to evaluate and publish acute and long-term performance of market-released SJM CRM products by analyzing product survival probabilities. Product status and any related adverse events will be collected to measure survival probabilities.

SCORE

Sponsor:
St. Jude Medical CRMD

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Probability Sample

Any patient indicated for a cardiac rhythm management (CRM) product like ICD, pacemaker, CRT-D, CRT-P, leads, etc. would be eligible for participation in the study.

Enrollment Criteria:

- Patient has a standard indication for a CRM implantable device.
- Patient is implanted with at least one new market-released SJM CRM product from a list provided by SJM (e.g pacemaker, ICD, CRT-D, CRT-P, pacing/sensing lead, defibrillation lead) within the last 90 days.
- Complete system implant information (e.g. model, serial number, location) is available at enrollment.
- Any product-related adverse event information at implant is available at enrollment.
- Patient or appropriate legal guardian is willing to provide authorization for registry participation.

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Heart Disease
Open to Enrollment

The OPTIMIZE Trial to Assess the Procedural and Clinical Value of the Svelte IDS and RX Sirolimus Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions in a Randomized Study

Indication for use: "The Svelte DES is indicated for improving coronary luminal diameter in patients with symptomatic heart disease, including patients with non-ST elevation MI due to discrete de novo native coronary artery lesions. The treated lesion length...

Investigator:
Jordan Safirstein, MD

should be less than the nominal stent length with a reference vessel diameter of 2.50 mm - 4.00 mm

OPTIMIZE

Sponsor:
Svelte Medical Systems, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Subject is an eligible candidate for percutaneous coronary intervention (PCI);
• Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia;
• Subject is an acceptable candidate for coronary artery bypass grafting (CABG);
• Subject has up to 3 de novo target lesions in up to 2 native coronary artery vessels, with no more than 2 lesions in a single vessel, each meeting the angiographic criteria and none of the exclusion criteria.
• Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥ 2.50 mm and ≤ 4.00 mm;

Exclusion Criteria:
• The subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina;
• The subject's target lesion(s) is located in the left main artery;
• The subject's target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery by visual estimate;
• The subject's target lesion(s) is located within a saphenous vein graft or arterial graft;
• The subject's target lesion(s) will be accessed via a saphenous vein graft or arterial graft;

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Heart Failure
Open to Enrollment

A Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass

A study to evaluate levosimendan compared with placebo in reducing the composite event rate of all-cause death, perioperative MI, need for new dialysis, or use of mechanical assist (IABP, LVAD or ECMO) in subjects with reduced ejection fraction undergoing...

Investigator:
James Slater, MD

cardiac surgery on cardiopulmonary bypass (CPB).

TNX-LVO-01 | PHASE III

Sponsor:
Tenax Therapeutics, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
- Documented LVEF ≤25% (CABG patients) or LVEF ≤35% (CABG with mitral valve, isolated mitral valve surgery patients, CABG with aortic valve) by ventriculogram, echocardiogram (ECHO), nuclear scan, or MRI within 60 days before surgery.
- Scheduled to undergo 1) CABG surgery, 2) CABG with aortic valve, 3) CABG with mitral valve replacement, or 4) isolated mitral valve repair; all patients on CPB.
- Signed (by the subjects or their legally acceptable representatives) informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:
-Restrictive or obstructive cardiomyopathy, constrictive pericarditis, restrictive pericarditis, pericardial tamponade, or other conditions in which cardiac output is dependent on venous return.
- Pulmonary disease (severe chronic obstructive pulmonary disease [COPD], asthma, or other condition) that, in the opinion of the investigator, represents an independent clinical risk to the cardiac surgery and recovery of the patient.
- Evidence of systemic bacterial, systemic fungal, or viral infection within 72 hours before surgery.
- Chronic dialysis at baseline or within 30 days of CABG/ valve surgery (either hemodialysis, peritoneal dialysis, continuous venovenous hemodialysis).
- Estimated glomerular filtration rate (eGFR) < 30 mL/kg/min or evidence of worsening renal function before CABG/valve surgery.
- Weight ≥ 170 kg.
- Patients whose SBP cannot be managed to ensure SBP > 90 mmHg at initiation of study drug.
- Heart rate ≥ 120 bpm, persistent for at least 10 minutes.
- Hemoglobin < 80 g/L.
- Serum potassium < 3.5 mmol/L and > 5.5 mmol/L at baseline.
- A history of Torsades de Pointes.
- Mechanical assist device (IABP, LVAD, ECMO) in previous 30 days or pre-planned use of IABP, LVAD, or ECMO during or following CABG/valve surgery.
- Patients with aortal femoral occlusive disease that would prohibit use of IABP.
- Liver dysfunction Child Pugh Class B or C
- Patients having severely compromised immune function
- Pregnant, suspected to be pregnant, or breast-feeding.
- Received an experimental drug or used an experimental medical device in previous 30 days.
- Known allergic reaction or sensitivity to Levosimendan or excipients.
- Received commercial Levosimendan within 30 days before the planned start of study drug.
- Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.

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Heart Failure
Open to Enrollment

A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients (NYHA Class II-IV) With Preserved Ejection Fraction

The purpose of this study is to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction.

Investigator:
Marc Goldschmidt, MD
CLCZ696D2301 | PHASE III

Sponsor:
Novartis Pharmaceuticals Corporation - NJ

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 55 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
- Left ventricular ejection fraction (LVEF) ≥45% prior to study entry.
- Symptom(s) of heart failure (HF) and requiring treatment with diuretic(s) for HF ≥30 days prior to study entry
- Current symptom(s) of HF
- Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram
- At least one of the following: a HF hospitalization within 9 months prior to study entry and/or an elevated NT-proBNP.

Exclusion Criteria:

- Any prior measurement of LVEF < 45%.
- Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention (PCI) within 30 days of entry.
- Patients who have had an MI, coronary artery bypass graft (CABG) or other event within the 6 months prior to entry unless an echo measurement performed after the event confirms a LVEF ≥45%.
- Current acute decompensated HF requiring therapy.
- Patients who require treatment with 2 or more of the following: an angiotensin converting enzyme inhibitor (ACEI), an angiotensin receptor blocker (ARB) or a renin inhibitor
- Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) <10 g/dl, or body mass index (BMI) > 40 kg/m2.
- Systolic blood pressure (SBP) ≥ 180 mmHg at entry, or SBP >150 mmHg and <180 mmHg at entry unless the patient is receiving 3 or more antihypertensive drugs.

Other protocol-defined inclusion/exclusion criteria may apply.

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Heart Failure
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A Prospective, Multicenter, Single-arm Study Designed to Assess the Safety of 3-month Dual Antiplatelet Therapy (DAPT) in Subjects at High Risk for Bleeding Undergoing Percutaneous Coronary Intervention (PCI) With the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System

The EVOLVE Short DAPT Study is a prospective, multicenter, single-arm study designed to assess the safety of 3-month DAPT in subjects at high risk for bleeding undergoing PCI with a SYNERGY Stent System.

Investigator:
Jordan Safirstein, MD
S2073 | PHASE IV

Sponsor:
Boston Scientific Corporation

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Subject is considered at high risk for bleeding, defined as meeting one or more of the following criteria at the time of enrollment:
◦≥ 75 years of age and, in the opinion of the investigator, the risk of major bleeding associated with >3 months of DAPT outweighs the benefit,
◦need for chronic or lifelong anticoagulation therapy,
◦history of major bleeding (severe/life threatening or moderate bleeding based on the GUSTO classification) within 12 months of the index procedure,
◦history of stroke (ischemic or hemorrhagic),
◦renal insufficiency (creatinine ≥2.0 mg/dl) or failure (dialysis dependent),
◦platelet count ≤100,000/μL
2. Subject must be at least 18 years of age
3. Subject must have had implantation of at least one SYNERGY stent within the preceding 3 calendar days
4. Subject must be able to take study required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin)
5. Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at the 3-month milestone, if eligible per protocol
6. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific procedures are performed
7. For subjects less than 20 years of age enrolled at a Japanese site, the subject/ the subject's legal representative must provide written informed consent before any study-specific tests or procedures are performed

Exclusion Criteria:
1. Subject with an indication for the index procedure of acute ST elevation MI (STEMI)
2. Subject with an indication for the index procedure of Non ST elevation MI (NSTEMI), based on the 3rd Universal MI definition
3. Subject with treatment with another coronary stent, other than SYNERGY, during the index procedure
4. Subject with planned staged procedures. (Note: Planned staged procedures are allowed if performed within 7 days and with only SYNERGY stents).
5. Subject has a known allergy to contrast (that cannot be adequately pre-medicated), the SYNERGY stent system or protocol-required concomitant medications (e.g., everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors and aspirin)
6. Subject with implantation of a drug-eluting stent within 9 months prior to index procedure
7. Subject previously treated at any time with intravascular brachytherapy
8. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
9. Subject is participating in an investigational drug or device clinical trial that has not reached its primary endpoint (Note: registry, observational, data collection studies are not exclusionary)
10. Subject intends to participate in an investigational drug or device clinical trial within 15 months following the index procedure (Note: registry, observational, data collection studies are not exclusionary)
11. Subject judged inappropriate for discontinuation from P2Y12 inhibitor use at 3 months, due to another condition requiring chronic P2Y12 inhibitor use
12. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 3 months following index procedure
13. Subject is a woman who is pregnant or nursing
14. Subject with a current medical condition with a life expectancy of less than 15 months
15. Target lesion(s) is located in the left main
16. Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate
17. Subject has unprotected left main coronary artery disease ( > 50% diameter stenosis)
18. Subject with treatment of more than 2 lesions during the index procedure
19. Target lesion(s) treated during the index procedure that involves a side branch ≥ 2.0 mm in diameter by visual estimate
20. Target lesion(s) treated during the index procedure that involves a clinically significant side branch < 2.0 mm in diameter by visual estimate that has a clinically significant stenosis at the ostium
21. Target lesion(s) is restenotic from a previous stent implantation
22. Target lesion(s) is located within a saphenous vein graft or an arterial graft
23. Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
24. Thrombus, or possible thrombus, present in the target vessel (by visual estimate)

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Heart Failure
Open to Enrollment

A Prospective, Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Effects of Macitentan on Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension Assessed by Cardiac Magnetic Resonance Imaging

The study evaluates the effect of macitentan on right ventricular and hemodynamic properties in patients with symptomatic pulmonary arterial hypertension. Patients are treated with macitentan for 1 year. Patients undergo right heart catheterization (RHC) at...

Investigator:
Marc Goldschmidt

baseline and Week 26. They also undergo cardiac magnetic resonance imaging (MRI) at baseline, Week 26 and Week 52. Safety is monitored throughout the study. The study has three stub-studies. Each patient can participate in no sub-study or in one sub-study. The sub-studies are: (1) metabolism sub-study (with PET-MR scans); (2) biopsy sub-study (biopsies taken during the RHC); (3) Echo sub-study.

REPAIR | PHASE IV

Sponsor:
Actelion Pharmaceuticals Ltd.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 64 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Signed informed consent prior to any study-mandated procedure
2. Symptomatic pulmonary arterial hypertension (PAH)
3. World Health Organization (WHO) Functional Class (FC) I to III
4. PAH etiology belonging to one of the following groups according to Nice classification:
◦Idiopathic PAH
◦Heritable PAH
◦Drug- and toxin-induced PAH
◦PAH associated with congenital heart diseases: only simple (atrial septal defect, ventricular septal defect, patent ductus arteriosus) congenital systemic to pulmonary shunts at least 2 year post surgical repair
5. Hemodynamic diagnosis of PAH confirmed by right heart catheterization (RHC) during screening showing:
• mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg and
◦PCWP (pulmonary capillary wedge pressure) or left ventricular end diastolic pressure (LVEDP) ≤ 12 mmHg and pulmonary vascular resistance (PVR) ≥ 4 Wood Units (WU) (320 dyn.sec.cm-5) or
◦12 mmHg ≤ PCWP or LVEDP ≤ 15 mmHg and PVR ≥ 6WU (480 dyn.sec.cm-5)
6. 6-minute walk distance (6MWD) ≥ 150 m during screening
7. For patients treated with oral diuretics, treatment dose must have been stable at least 1 month prior to RHC during the screening period
8. For patients treated with phosphodiesterase type-5 (PDE-5) inhibitors, treatment dose must have been stable at least 3 months prior to RHC during the screening period
9. For patients treated with beta blockers, treatment dose must have been stable at least 1 month prior to the RHC during the screening period
10. Men or women ≥18 and < 65 years
11. Women of childbearing potential (defined in protocol) must:
◦Have a negative serum pregnancy test during screening and a negative urine pregnancy test on Day 1, and
◦Agree to use reliable methods of contraception (defined in protocol) from screening up to 30 days after study treatment discontinuation, and
◦Agree to perform monthly pregnancy tests up to 30 days after study treatment discontinuation

Exclusion Criteria:
1. Body weight < 40 kg
2. Body mass index (BMI) > 35kg/m2. For patients with 30kg/m2 < BMI < 35kg/m2, an eligibility form will be submitted to a Steering Committee member who will reserve the right to exclude the patient.
3. Pregnancy, breastfeeding or intention to become pregnant during the study
4. Recently started (< 8 weeks prior to informed consent signature) or planned cardio-pulmonary rehabilitation program
5. Known concomitant life-threatening disease with a life expectancy < 12 months
6. Any condition likely to affect protocol or treatment compliance
7. Hospitalization for PAH within 3 months prior to informed consent signature
8. Left atrial volume indexed for body surface area ≥ 43mL/m2 by echocardiography or cardiac MRI
9. Valvular disease grade 2 or higher
10. History of pulmonary embolism or deep vein thrombosis
11. Documented moderate to severe chronic obstructive pulmonary disease
12. Documented moderate to severe restrictive lung disease
13. Historical evidence of significant coronary artery disease established by:
◦History of myocardial infarction or
◦More than 50% stenosis in a coronary artery (by percutaneous coronary intervention or angiography) or
◦Elevation of the ST segment on electrocardiogram or
◦History of coronary artery bypass grafting or
◦Stable angina
14. Diabetes mellitus
15. Moderate to severe renal insufficiency (calculated creatinine clearance < 60 mL/min/1.73 m2)
16. Cancer
17. Systolic blood pressure < 90 mmHg
18. Severe hepatic impairment (with or without cirrhosis) according to National Cancer Institute organ dysfunction working group criteria, defined as total bilirubin > 3 × upper limit of the normal range (ULN) accompanied by an aspartate aminotransferase (AST) elevation > ULN at Screening.
19. Hemoglobin < 100g/L
20. AST and/or alanine aminotransferase (ALT) > 3× ULN
21. Need for dialysis
22. Responders to acute vasoreactivity test based on medical history
23. Prior use of endothelin receptor antagonists (ERAs), stimulators of soluble guanylate cyclase or prostacyclin or prostacyclin analogues
24. Treatment with strong inducers of cytochrome P450 isozyme 3A4 (CYP3A4) within 4 weeks prior to study treatment initiation (e.g., carbamazepine, rifampicin, rifabutin, phenytoin and St. John's Wort)
25. Treatment with strong inhibitors of CYP3A4 within 4 weeks prior to study treatment initiation (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, and saquinavir)
26. Treatment with another investigational drug (planned, or taken within the 3 months prior to study treatment initiation).
27. Hypersensitivity to any ERA or any excipients of the formulation of macitentan (lactose, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, polyvinyl alcohol, polysorbate, titanium dioxide, talc, xanthan gum, and lecithin soya)
28. Claustrophobia
29. Permanent cardiac pacemaker, automatic internal cardioverter
30. Metallic implant (e.g., defibrillator, neurostimulator, hearing aid, permanent use of infusion device)
31. Atrial fibrillation, multiple premature ventricular or atrial contractions, or any other condition that would interfere with proper cardiac gating during MRI.
32. For patients enrolling in the metabolism sub-study only: glucose intolerance
33. For patients enrolling in the biopsy sub-study only: PAH etiology belonging to Nice classification 1.4.4: PAH associated with congenital heart diseases

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Heart Failure
Open to Enrollment

Attain Stability™ Quad Clinical Study

The purpose of this clinical study is to evaluate the safety and efficacy of the Attain Stability Quadripolar MRI SureScan Left Ventricular (LV) lead (Model 4798).

Investigator:
Robert Coyne, MD
Attain QUAD

Sponsor:
Medtronic, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Patient meets CRT implant criteria as determined by local regulatory and/or hospital policy (i.e. US subjects should meet CRT device indications per the HRS/ACC/AHA guidelines)
• Patient (or legally authorized representative) has signed and dated the study-specific Informed Consent Form
• Patient is 18 years of age or older, or is of legal age to give informed consent per local and national law
• Patient is expected to remain available for follow-up visits

Exclusion Criteria:
• Patient has had a previous unsuccessful LV lead implant attempt
• Patient has a previous CRT system or LV lead implanted (for example, transvenous or epicardial)
• Patient is currently implanted with a recalled (i.e. market-withdrawn, recalled or safety alert) RA and/or RV lead
• Patient has known coronary venous vasculature that is inadequate for lead placement
• Patient has unstable angina pectoris or has had an acute myocardial infarction (MI) within the past 30 days
• Patient has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past 90 days
• Patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve)
• Patient has had a heart transplant (patients waiting for heart transplants are allowed in the study)
• Patient has known renal insufficiency that would prevent them from receiving an occlusive venogram during the implant procedure
• Patient is contraindicated for <1mg dexamethasone acetate
• Patient is enrolled in any concurrent drug and/or device study that may confound the results of this study
• Patient has a terminal illness and is not expected to survive more than six months
• Patient meets exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc.)
• Patient is unable to tolerate an urgent thoracotomy

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Heart Failure
Open to Enrollment

CardioMEMS HF System Post Approval Study

The purpose of the CardioMEMS HF System Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF System in patients with NYHA class III heart failure in a commercial setting.

Investigator:
Marc Goldschmidt, MD
CardioMEMS

Sponsor:
St. Jude Medical CRMD

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample
Study Population

patients with NYHA class III heart failure
Criteria

Inclusion Criteria:
- Diagnosis of NYHA class III heart failure
- At least 1 heart failure hospitalization within previous 12 months
- Patients with reduced LVEF heart failure should be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the patient is intolerant to beta blockers, ACE-I or ARB
- BMI ≤ 35. Patients with BMI >35 will require their chest circumference to be measured at the axillary level. If > 65 inches the patient will not be eligible for the study.
- Pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the right heart catheterization)

Exclusion Criteria:
- Active infection
- History of recurrent (> 1) pulmonary embolism or deep vein thrombosis
- Inability to tolerate a right heart catheterization
- A major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within previous 2 months
- Cardiac resynchronization device (CRT) implanted within previous 3 months
- Glomerular Filtration Rate (GFR) < 25 ml/min (obtained within 2 weeks of implant) who are non-responsive to diuretic therapy or who are on chronic renal dialysis
- Congenital heart disease or mechanical right heart valve
- Likely to undergo heart transplantation or VAD within the next 6 months
- Known coagulation disorders
- Hypersensitivity or allergy to aspirin, and/or clopidogrel

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Heart Failure
Open to Enrollment

Correlation of Bioimpedance Measurements From the SOZO Device With Pulmonary Arterial Pressure Measurements From the CardioMEMS HF System

This study aims to establish the degree to which change in the ratio of ECF to TBW measured using the SOZO BIS device correlates with change in end-expiratory end-diastolic PAP measured using the CardioMEMS HF System (St. Jude Medical).

Investigator:
Marc Goldschmidt, MD
SOZO

Sponsor:
ImpediMed Limited

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Study Population:
Heart failure patients who have a cardioMEMS device

Inclusion Criteria:
1. Age 18 years or older.
2. NYHA Class III HF.
3. Patient has undergone implantation of CardioMEMS HF System (St. Jude Medical).
4. Patient is characterized by at least one of the following:
◦ CardioMEMS implanted within the previous 90 days
◦ Received treatment with intravenous diuretics within the previous 30 days
◦ Received dose escalation of oral diuretics at least twice within the previous 30 days
5. Patient is able to sit upright for BIS measurements.
6. Patient provides written informed consent and authorization to use and disclose health information.

Exclusion Criteria:
1. Patient is enrolled in a concurrent interventional study of an experimental treatment that may confound the results of this study, in the investigator's opinion.
2. Patient has a clinical condition that would not allow them to complete the study.
3. Patient is pregnant or lactating.
4. Patient has nephrotic syndrome or nephrosis.
5. Patient has estimated glomerular filtration rate (eGFR) < 20 ml/min/1.73m2 or end-stage renal disease requiring chronic dialysis.
6. Patient has been diagnosed with lymphedema.
7. Patient has chronic liver failure or cirrhosis.
8. Patient has a moderate or large pleural effusion as seen on chest X-ray.
9. Patient has been diagnosed with thrombophlebitis or deep vein thrombosis in arms or legs in the past 90 days.
10. Patient has an implanted cardiac rhythm management device (pacemaker or implantable cardioverter defibrillator).
11. Patient has an amputation of a limb.

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Heart Failure
Open to Enrollment

Late Sodium Current Blockade in High-Risk ICD Patients

The purpose of the study is to see how effective a drug called ranolazine is in reducing the risk of ventricular arrhythmia and death in people with implantable cardioverter-defibrillators (ICDs). This drug will be used with standard medications that is routinely...

Investigator:
Stephen Winters, MD

prescribed in enrolled patients.

RAID

Sponsor:
National Institute of Health

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 21 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1,440 high-risk patients with ischemic/nonischemic cardiomyopathy who receive their ICDs as standard of care for primary or secondary prevention of mortality following approved indications for ICD therapy. High-risk patients will be defined as:

Secondary Prevention Patients Subjects with ischemic or nonischemic cardiomyopathy, qualified for or with existing ICD (or CRT-D) after documented VT/VF or cardiac arrest (secondary prevention of mortality). Secondary prevention subjects with existing implants are eligible regardless of when the implant was received (subjects could be recruited from outpatient clinics or from inpatient activity including during re-implant or other procedures).

Primary Prevention Patients

1. Patients with primary prevention indications for ischemic or non-ischemic cardiomyopathy with EF≤35%, with existing devices (ICD/CRT-D), regardless of when the device was implanted, who have experienced at least ONE episode of VT/VF appropriately treated with ICD therapy (ATP or shock) or had untreated NSVT lasting at least 10 beats with heart rate of at least 170 bpm, documented by electrogram of their implanted device.
2. Patients with ischemic or non-ischemic cardiomyopathy with EF≤35%, who have been implanted within the last 2 years (initial ICD/CRT-D implants, including upgrades from pacemakers) who have NOT experienced VT/VF treated with ICD therapy (ATP or shock), AND who have ONE of the following additional criteria: BUN≥26 mg/dl or QRS>120ms or Atrial Fibrillation or NSVT documented by ECG/Holter or >500 Ventricular Premature Beats (VPBs)documented in a 24-hour Holter.
o Stable optimal pharmacologic therapy for the cardiac condition
o Age: equal to 21 years without upper limit

Exclusion Criteria:
• Patient receiving first device with coronary artery bypass graft surgery within the last 3 calendar months prior to date consent obtained
• Patients receiving first device with percutaneous coronary intervention within the last 1 calendar month prior to date consent obtained
• Patient receiving first device with enzyme-positive myocardial infarction with the past 3 calendar months prior to date consent obtained
• Patient receiving first device with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary intervention in the foreseeable future
• Patient in NYHA Class IV
• Patients receiving prophylactic ablation of ventricular substrate
• Patients with preexisting QTc prolongation >550ms
• Patients on strong CYP3A inhibitors (including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir and saquinavir and moderate CYP3A inhibitors, including, diltiazem, verapamil, aprepitant, erythromycin, fluconazole and grapefruit juice or grapefruit-containing products.
• Patients on CYP3A inducers such as rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine and St.John's wort
• Patients with inherited arrhythmia disorders such as Brugada's, ARVD, LQTS or hypertrophic cardiomyopathy
• Patient who is pregnant or plans to become pregnant during the course of the trial (patients at child bearing age who use prescribed pharmaceutical contraceptives could be enrolled)
• Patient with irreversible brain damage from preexisting cerebral disease
• Patient with presence of any disease, other than the patient's cardiac disease, associated with a reduced likelihood of survival for the duration of the trial, e.g., cancer, uremia, liver failure, etc.
• Patient with chronic renal disease with creatinine >2.5 mg/dl
• Patient participating in any other clinical trial
• Patient unwilling or unable to cooperate with the protocol
• Patient who lives at such a distance from the clinic that travel for follow-up visits would be unusually difficult
• Patient who does not anticipate being a resident of the area for the scheduled duration of the trial
• Patients who are decisionally impaired adults, those of questionable capacity, and those who cannot consent for themselves will not be recruited for this study.
• Patient unwilling to sign the consent for participation

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Heart Failure
Open to Enrollment

Percutaneous Mitral Valve Replacement EvaLuation Utilizing IDE Early Feasibility Study (PRELUDE)

The purpose of this study is to assess the safety and performance of the Caisson Interventional Transcatheter MitralValve Replacement (TMVR) system for the treatment of severe symptomatic MitralValve Regurgitation (MR).

Investigator:
Robert Kipperman, MD
PRELUDE | PHASE I

Sponsor:
Caisson Interventional, LLC

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Has severe mitral regurgitation
• New York Heart Association (NYHA) Class II, III, IVa or heart failure
• High risk for cardiovascular surgery

Exclusion Criteria:
• Excessive calcification or thickening of mitral valve annulus, severe mitral stenosis, fused commissures, valvular vegetation or mass
• Left ventricular end diastolic dimension > 7cm
• Left ventricular outflow tract obstruction
• Severe right ventricular dysfunction
• Stroke within 90 days; transischemic attack or myocardial infarction within 30 days of the index procedure

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Heart Failure
Open to Enrollment

REDUCE LAP-HF TRIAL: A Study to Evaluate the DC Devices, Inc. IASD™ System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure

The objective of this clinical study is to evaluate the safety and performance of the IASD System II in the treatment of heart failure patients with elevated left atrial pressure, who remain symptomatic despite appropriate medical management.

Investigator:
Marc Goldschmidt, MD
REDUCE LAP-HF

Sponsor:
Corvia Medical, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 40 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Key Inclusion Criteria:
1. Chronic symptomatic Heart Failure (HF) documented by one or more of the following:
1. New York Heart Association (NYHA) Class II/III/ambulatory class IV symptoms (Paroxysmal nocturnal dyspnea, Orthopnea, Dyspnea on mild or moderate exertion) at screening visit; or signs (Any rales post cough, Chest x-ray demonstrating pulmonary congestion,) within past 12 months;
2. One hospital admission for which HF was a major component of the hospitalization within the 12 months prior to study entry (transient heart failure in the context of myocardial infarction does not qualify);
3. On-going management with recommended heart failure medications and comorbidities for several months according to the guidelines (2012 ESC Guidelines for diagnosis and Treatment of Acute and Chronic Heart Failure).
2.Age ≥ 40 years old
3.Left ventricular ejection fraction (obtained by echocardiography) ≥ 40%
4. Elevated left ventricular filling pressures with a gradient compared to CVP documented by :
1. PCWP or LVEDP at rest ≥ 15 mmHg, and greater than CVP, OR
2. PCWP during supine bike exercise ≥ 25mm Hg, and CVP < 20 mm Hg

Key Exclusion Criteria:
3. Severe heart failure defined as:
1. ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
2. Fick Cardiac Index < 2.0 L/min/m2
3. Requiring inotropic infusion (continuous or intermittent) within the past 6 months
4. Patient is on the cardiac transplant waiting list 4. Inability to perform 6 Minute Walk Test 5. Known significant coronary artery disease (stenosis >70%) 6. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months 7. Known severe carotid artery stenosis (> 70%) 8. Presence of significant valve disease defined by echocardiography as: a) Mitral valve regurgitation defined as grade >2+ MR b) Tricuspid valve regurgitation defined as grade ≥ 2+ TR; c) Aortic valve disease defined as ≥ 2+ AR or moderate AS

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Kidney Cancer
Open to Enrollment

A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Atezolizumab (Anti−PD-L1 Antibody) as Adjuvant Therapy in Patients With Renal Cell Carcinoma at High Risk of Developing Metastasis Following Nephrectomy

This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy.

Investigator:
Gregg Zimmerman, MD
WO39210 | PHASE III

Sponsor:
Genentech, Inc

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• ECOG performance status of less than or equal to (• Pathologically confirmed RCC with a component of either clear cell histology or sarcomatoid histology that has not been previously treated in the adjuvant or neoadjuvant setting and classified as being at high risk of RCC recurrence
• Radical or partial nephrectomy with lymphadenectomy in select participants
• Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) of the pelvis, abdomen, and chest no more than 4 weeks prior to randomization.
• Absence of brain metastasis, as confirmed by a negative CT with contrast or magnetic resonance imaging (MRI) scan of the brain, no more than 4 weeks prior to randomization. Applicable only to metastasectomy participants
• Full recovery from nephrectomy or metastasectomy within 12 weeks from randomization following surgery

Exclusion Criteria:
• Bilateral synchronous tumors with inheritable forms of RCC including von Hippel-Lindau
• Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment
• Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days or five half-lives of the investigational agent, whichever is longer, prior to enrollment
•Malignancies other than RCC within 5 years prior to Cycle 1, Day 1
• Participants with prior allogeneic stem cell or solid organ transplantation
• History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan
• Positive test for HIV
• Participants with active hepatitis B or hepatitis C
• Active tuberculosis
• Severe infections within 4 weeks prior to randomization including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
• Major surgical procedure within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
• Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1
• Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
• Prior treatment with cluster of differentiation (CD)137 agonists, anti-cytotoxic T-lymphocyte-associated protein-4 (anti-CTLA-4), anti-programmed death-1 (anti-PD−1), or anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibody or pathway-targeting agents
• Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to randomization
• Treatment with systemic immunosuppressive medications (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti−tumor necrosis factor agents) within 2 weeks prior to randomization or anticipated need for systemic immunosuppressive medications during the study

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Kidney Cancer
Open to Enrollment

A Randomized Phase 2 Trial of Axitinib and TRC105 Versus Axitinib Alone (Including a lead-in Phase 1B Dose Escalation Portion) in Patients With Advanced or Metastatic Renal Cell Carcinoma

Phase 1b: To evaluate safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard dose axitinib in patients with advanced renal cell carcinoma. Phase 2: To estimate the PFS of patients with advanced or metastatic RCC...

Investigator:
Eric Whitman, MD

by RECIST 1.1 criteria in patients treated with axitinib and TRC105 compared to those treated with axitinib alone, following failure of one prior VEGF TKI.

105RC101 | PHASE II

Sponsor:
Tracon Pharmaceuticals, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:

- Histologically confirmed advanced or metastatic renal cell carcinoma with a clear cell component that has progressed by investigator assessment following treatment with one and only one multi-targeted tyrosine kinase inhibitor (TKI) other than axitinib that targets the VEGF receptor (VEGFR) (e.g., sunitinib, pazopanib, sorafenib, tivozanib, cabozantinib). One prior immunotherapy (interleukin-2 or interferon-alpha or immune checkpoint inhibitor or tumor vaccine) and one prior mTOR inhibitor treatment are allowed.
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission per investigators' clinical judgment.
- Measurable disease by RECIST 1.1 criteria
- Age of 18 years or older
- ECOG performance status ≤ 1
- Resolution of all acute adverse events resulting from prior cancer therapies to NCI CTCAE grade ≤ 1 or baseline (except alopecia)
- Adequate organ function as defined by the following criteria:
- Willingness and ability to consent for self to participate in study
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

- Prior treatment with TRC105 or axitinib or any agent targeting the endoglin pathway (including a fusion protein that binds bone morphogenic protein)
- Grade 3 or 4 toxicity related to prior VEGFR TKI that did not resolve to grade 1
- Current treatment on another therapeutic clinical trial
- Receipt of a small molecule anticancer agent, including an investigational anticancer small molecule, within 14 days of starting study treatment or receipt of a biologic anticancer agent (e.g., antibody) within 28 days of starting study treatment.
- Prior radiation therapy within 28 days of starting the study treatment, except radiation therapy for bone metastases or radiosurgery is permitted up to 14 days of starting treatment
- No major surgical procedure or significant traumatic injury within 6 weeks prior to study registration, and must have fully recovered from any such procedure; date of surgery (if applicable). Note: the following are not considered to be major procedures and are permitted up to 7 days before therapy initiation: Thoracentesis, paracentesis, port placement, laparoscopy, thorascopy, tube thoracostomy, bronchoscopy, endoscopic ultrasonographic procedures, mediastinoscopy, skin biopsies, incisional biopsies, imaging-guided biopsy for diagnostic purposes, and routine dental procedures
- Uncontrolled chronic hypertension defined as systolic > 150 or diastolic > 90 despite optimal therapy (initiation or adjustment of BP medication prior to study entry is allowed provided that the average of 3 BP readings at a visit prior to enrollment is < 150/90 mm Hg)
- History of brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. Patients with radiated or resected lesions are permitted, provided the lesions are fully treated and inactive, patients are asymptomatic, and no steroids have been administered for at least 28 days.
- Angina, MI, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, PTCA or CABG within the past 6 months. Deep venous thrombosis within 6 months unless the patient is anticoagulated without the use of warfarin for at least 2 weeks. In this situation, low molecular weight heparin is preferred.
- Active bleeding or pathologic condition that carries a high risk of bleeding (e.g. hereditary hemorrhagic telangiectasia).
- Thrombolytic use (except to maintain i.v. catheters) within 10 days prior to first day of study therapy
- Known active viral or nonviral hepatitis or cirrhosis
- History of hemorrhage or hemoptysis (> ½ teaspoon bright red blood) within 3 months of starting study treatment
- History of peptic ulcer disease within 3 months of treatment, unless treated for the condition and complete resolution has been documented by esophagogastroduodenoscopy (EGD) within 28 days of starting study treatment
- History of gastrointestinal perforation or fistula in the past 6 months, or while previously on antiangiogenic therapy, unless underlying risk has been resolved (e.g., through surgical resection or repair)
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
- Requirement for concomitant medications that strongly induce or inhibit CYP3A4/5
- Pregnancy or breastfeeding. Female patients must be surgically sterile (i.e.: hysterectomy) or be postmenopausal, or must agree to use effective contraception during the study and for 3 months following last dose of TRC105. All female patients of reproductive potential must have a negative pregnancy test (serum or urine) within 7 days prior to first dose. Male patients must be surgically sterile or must agree to use effective contraception during the study and for 3 months following last dose of TRC105. The definition of effective contraception will be based on the judgment of the Principal Investigator or a designated associate.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for this study

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Kidney Cancer
Open to Enrollment

EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study

This phase III trial is studying everolimus to see how well it works in treating patients with kidney cancer who have undergone surgery.

Investigator:
Bonni Guerin, MD
S0931 | PHASE III

Sponsor:
Southwest Oncology Group

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:
•Histologically or cytologically confirmed renal cell carcinoma
◦Clear cell or non-clear cell allowed
◾No disease of the collecting duct or medullary carcinoma
◦Considered pathologically either intermediate high-risk or very high-risk disease
◦No history of distant metastases
◦Patients with microvascular invasion of the renal vein of any grade or stage (as long as M0) are eligible
•Have undergone a full surgical resection (radical nephrectomy or partial nephrectomy) including removal of all clinically positive nodes
◦Surgical margins must be negative
◾Patients with positive renal vein margins are eligible unless there is invasion of the renal vein wall at the margin (provided no other margins are positive)
◦Patients must be registered within 84 days after the date of the first surgical resection of the first tumor
•No evidence of residual or metastatic renal cell cancer on CT scan of the chest, abdomen, and pelvis (all with oral and IV contrast) performed after nephrectomy and within 28 days before registration
◦MRI scans of the abdomen and pelvis with gadolinium and a non-contrast CT scan of the chest may be substituted if the patient is not able to have CT scans with IV contrast


PATIENT CHARACTERISTICS:
•Zubrod performance status 0-1
•ANC ≥ 1,500/mm^3
•Platelet count ≥ 100,000/mm^3
•Serum creatinine ≤ 2.0 times upper limit of normal (ULN) OR calculated creatinine clearance ≥ 30 mL/min
•Bilirubin ≤ 1.5 times ULN
•SGOT and SGPT ≤ 2.5 times ULN
•Not pregnant or nursing
•Fertile patients must use effective contraception during and for up to 8 weeks after completion of study treatment
•Able to take oral medications
•Patients must not have any of the following:
◦NYHA class III-IV cardiac disease (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort)
◦Unstable angina pectoris
◦Myocardial infarction within the past 6 months
◦Serious uncontrolled cardiac arrhythmia
•Patients must NOT have liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh Class C)
•HBV and HCV testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection
•Must be able to take oral medications
•No impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
•No known history of HIV seropositivity
•No known uncontrolled, underlying pulmonary disease (spirometry and DLCO ≤ 50% of predicted OR oxygen saturation ≤ 88% at rest on room air)
•No uncontrolled hyperlipidemia (fasting serum cholesterol > 300 mg/dL AND fasting triglycerides > 2.5 times ULN) obtained within 28 days prior to registration
◦Optimal lipid control must be achieved before registration and monitored during protocol treatment
•No uncontrolled diabetes mellitus (defined by fasting serum glucose > 1.5 times ULN) obtained within 28 days prior to registration.
◦Optimal glucose control must be achieved before registration and monitored during protocol treatment
•No prior malignancies except for any of the following:
◦Adequately treated basal cell or squamous cell skin cancer
◦In situ cervical cancer
◦Adequately treated stage I or stage II cancer from which the patient is currently in complete remission
◦Any other cancer from which the patient has been disease-free for 5 years
•No known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to their excipients
•No contraindications to receiving either IV iodine-based contrast or gadolinium

PRIOR CONCURRENT THERAPY:
•See Disease Characteristics
•Patients must have recovered from any surgery-related complications
•No prior anticancer therapy for renal cell carcinoma including systemic therapy in the adjuvant or neoadjuvant setting, immunotherapy, investigational therapy, surgical metastasectomy, or radiotherapy
•More than 14 days since prior and no concurrent strong CYP3A4 inhibitors (i.e., ketoconazole, itraconazole, voriconazole, posaconazole, fluvoxamine, nefazodone, nelfinavir, or ritonavir) or strong CYP3A4 inducers (i.e., phenytoin, rifampin, or rifabutin)
•More than 7 days since prior and no concurrent live vaccines
•No other concurrent anticancer agents including investigational agents
•No concurrent chronic treatment with systemic steroids or another immunosuppressive agent
◦Topical or inhaled corticosteroids are allowed

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Liver Cancer
New

A Phase 3 Randomized, Open-Label Study Comparing Pexa Vec (Vaccinia GM CSF / Thymidine Kinase-Deactivated Virus) Followed by Sorafenib Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC) Without Prior Systemic Therapy

This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not...

Investigator:
Lawrence Harrison, MD

received prior systemic therapy.

JX594-HEP024 | PHASE III

Sponsor:
SillaJen Biotherapeutics, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Histological/cytological diagnosis of primary HCC
• Advanced stage HCC (Barcelona Clinic Liver Cancer [BCLC] Stage C or B per American Association for the Study of Liver Disease [AASLD] guidelines)
• At least one measurable viable tumor in the liver, ≥1 cm longest diameter (LD), using a dynamic imaging technique (arterial phase of triphasic computerized tomography [CT] scan, or dynamic contrast-enhanced magnetic resonance imaging [MRI]), and injectable under imaging-guidance (CT and/or ultrasound)
• Child-Pugh Class A
• Performance status 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
• Adequate hematological, hepatic, and renal function:
• Additional inclusion criteria exist

Exclusion Criteria:
• Histological diagnosis of cholangiocarcinoma, hepatocholangiocarcinoma, fibrolamellar carcinoma and hepatoblastoma
• Symptomatic cardiovascular disease, including but not limited to significant coronary artery disease (e.g., requiring angioplasty or stenting) or congestive heart failure within the preceding 12 months
• Current or past history of cardiovascular disease (e.g.. past history of myocardial infarction, ischemic cardiomyopathy) unless cardiology consultation and clearance has been obtained for study participation
• History of moderate or severe ascites, bleeding esophageal varices, hepatic encephalopathy or pleural effusions related to liver insufficiency within 6 months of screening
• Bulky disease patients - tumors encompassing >50% of the liver volume and / or inferior vena cava invasion
• Known significant immunodeficiency due to underlying illness (e.g., HIV/AIDS) and/or immune-suppressive medication including high-dose corticosteroids
• Ongoing severe inflammatory skin condition (as determined by the Investigator) requiring medical treatment
• History of severe eczema (as determined by the Investigator) requiring medical treatment
• Additional exclusion criteria exist

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Lung Cancer
Open to Enrollment

A Master Protocol of Phase 1/2 Studies of Nivolumab in Advanced NSCLC Using Nivolumab as Maintenance After Induction Chemotherapy or as First-line Treatment Alone or in Combination With Standard of Care Therapies (CheckMate 370: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 370)

The purpose of this study is to determine whether nivolumab monotherapy or in combination with Standard of care (SOC) therapies will provide clinical benefit (i.e., PFS, OS, and DOR) without unacceptable toxicity in advanced Non-Small Cell Lung Cancer patients.

Investigator:
Dennis Lowenthal, MD

The purpose of this study is to determine whether nivolumab monotherapy or in combination with Standard of care (SOC) therapies will provide clinical benefit (i.e., PFS, OS, and DOR) without unacceptable toxicity in advanced Non-Small Cell Lung Cancer patients.

CA209-370 | PHASE I/II

Sponsor:
Bristol-Myers Squibb Company - CT

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Histologically confirmed locally advanced or stage IV NSCLC
• Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
• Tumor tissue sections must be available for biomarker evaluation

Exclusion Criteria:
• Untreated or active/progressing Central Nervous system (CNS) metastases
• Active, known or suspected autoimmune disease
• Known history of testing positive for HIV or AIDS
• Active or chronic infection of hepatitis B virus or hepatitis C

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Lung Cancer
Open to Enrollment

A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-small Cell Lung Cancer: Crizotinib Versus Placebo for Patients With Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

This randomized phase III trial studies how well crizotinib works and compares it to placebo in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase...

Investigator:
Missak Haigentz, MD

(ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation.

E4512 | PHASE III

Sponsor:
Eastern Cooperative Oncology Group

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Patients must have undergone complete surgical resection of their stage IB (>= 4 cm), II, or non-squamous IIIA NSCLC per American Joint Committee on Cancer (AJCC) 7th edition and have had negative margins; N3 disease is not allowed
• Baseline chest computed tomography (CT) with or without contrast must be performed within 6 months (180 days) prior to randomization to ensure no evidence of disease; if clinically indicated additional imaging studies must be performed to rule out metastatic disease
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization
• Positive for translocation or inversion events involving the ALK gene locus (e.g. resulting in echinoderm microtubule associated protein like 4 [EML4]-ALK fusion) as determined by the Vysis Break Point fluorescence in situ hybridization (FISH) assay and defined by an increase in the distance between 5' and 3' ALK probes or the loss of the 5' probe; this must have been performed:
◦ By a local Clinical Laboratory Improvement Amendments (CLIA) certified laboratory: report must indicate the results as well as the CLIA number of the laboratory which performed the assay; tissue must be available for submission for central, retrospective confirmation of the ALK fusion status via ALCHEMIST-SCREEN (ALLIANCE A151216) OR
◦ Patient registered to and the ALK fusion status performed centrally on the ALCHEMIST-SCREEN (ALLIANCE A151216)
• Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood or urine pregnancy test within 72 hours prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
• Women of childbearing potential and sexually active males must be strongly advised to practice abstinence or use an accepted and effective method of contraception
• Patients must NOT have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• No known interstitial fibrosis or interstitial lung disease
• No prior treatment with crizotinib or another ALK inhibitor
• No ongoing cardiac dysrhythmias of grade >= 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, uncontrolled atrial fibrillation (any grade), or corrected QT (QTc) interval > 470 msec
• No use of medications, herbals, or foods that are known potent cytochrome P450, subfamily 3A, polypeptide 4 (CYP3A4) inhibitors or inducers, included but not limited to those outlined
• Patients must be adequately recovered from surgery at the time of randomization
• The minimum time requirement between date of surgery and randomization must be at least 4 weeks (28 days)
• The maximum time requirement between surgery and randomization must be:
◦ 3 months (90 days) if no adjuvant chemotherapy was administered
◦ 8 months (240 days) if adjuvant chemotherapy was administered
◦ 10 months (300 days) if adjuvant chemotherapy and radiation therapy were administered
• Patients must have completed any prior adjuvant chemotherapy or radiation therapy 2 or more weeks (6 or more weeks for mitomycin and nitrosoureas) prior to randomization and be adequately recovered at the time of randomization
◦ NOTE: Patients taking low dose methotrexate for non-malignant conditions and other cytotoxic agents for non-malignant conditions are allowed to continue treatment while on study
◦ NOTE: Neo-adjuvant chemotherapy or radiation therapy for the resected lung cancer is not permitted
• Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
• Total serum bilirubin =< 1.5 x ULN
• Absolute neutrophil count (ANC) >= 1500/mm^3
• Platelets >= 30,000/mm^3
• Hemoglobin >= 8.0 g/dL
• Serum creatinine =< 2 x ULN
• Prior to randomization patients with any non-hematologic toxicity from surgery, chemotherapy, or radiation must have recovered to grade =< 1 with the exception of alopecia and the criteria outlined
• Patients must not have any history of cancer within 5 years from randomization, with the exception of in-situ carcinomas and non-melanoma skin cancer
• Patients may not be receiving any other investigational agents while on study

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Lung Cancer
Open to Enrollment

A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC)

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus platinum-based SoC chemotherapy in the first-line treatment of patients...

Investigator:
Dennis Lowenthal, MD

with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type advanced or metastatic NSCLC

MYSTIC | PHASE III

Sponsor:
AstraZeneca

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 150 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:

For inclusion in the study, patients should fulfill the following criteria:
• Aged at least 18 years
• Documented evidence of Stage IV NSCLC
• No activating EGFR mutation or ALK rearrangement
• No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC
• World Health Organization (WHO) Performance Status of 0 or 1

Exclusion Criteria:

Patients should not enter the study if any of the following exclusion criteria are fulfilled:
• Mixed small-cell lung cancer and NSCLC histology or not otherwise specified (NSCLC NOS)
• Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids)
• Prior exposure to Immunomodulatory therapy (IMT), including, but not limited to, other anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies, excluding therapeutic anticancer vaccines
• Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)

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Lung Cancer
Open to Enrollment

A Phase III, Open-label, Randomized Study to Investigate the Efficacy and Safety of MPDL3280A (Anti-PD-L1 Antibody) Compared With Best Supportive Care Following Adjuvant Cisplatin-based Chemotherapy in PD-L1-Selected Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer

The primary efficacy objective of the study is to evaluate the efficacy of 16 cycles of Atezolizumab (MPDL3280A) treatment compared with best supportive care as measured by disease-free survival (DFS) as assessed by the investigator.

Investigator:
Dennis Lowenthal, MD
GO29527 | PHASE III

Sponsor:
Genentech, Inc

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:

Inclusion Criteria for Enrollment Phase:
• Age >/= 18 years
• Ability to comply with protocol
• ECOG performance status of 0 or 1
• Histological or cytological diagnosis of Stage IB (tumors >/= 4 cm) -IIIA (T2-3 N0, T1-3 N1, T1-3 N2) NSCLC (per the UICC/AJCC staging system, 7th edition; Detterbeck et al. 2010)
• Patients must have had complete resection of NSCLC 6-12 weeks (>/= 42 days and • Complete mediastinal lymph node dissection (MLND) is required. If mediastinoscopy was not performed preoperatively, it is required that, at a minimum, mediastinal lymph node systematic sampling will have occurred. Systematic sampling is defined as removal of at least one representative lymph node at specified levels. MLND entails resection of all lymph nodes at those same levels. For a right thoracotomy, sampling or MLND is required at levels 4 and 7 and for a left thoracotomy, levels 5 and/or 6 and 7. If there is clear documentation in the operative report or in a separately submitted addendum by the surgeon of exploration of the required lymph node areas, the patient will be considered eligible if no lymph nodes are found in those areas. If patients have documented N2 disease in one level (per the UICC/AJCC staging system, 7th edition; Detterbeck et al. 2010), not all levels need to be sampled.
• Eligibility to receive a cisplatin-based chemotherapy regimen
• Adequate hematologic and end-organ function, defined by the following laboratory results obtained within 14 days prior to enrollment
• Women who are not postmenopausal (>/= 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of cisplatin-based chemotherapy.

Inclusion Criteria for Randomized Phase:
• Women who are not postmenopausal (>/= 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study drug or BSC

Exclusion Criteria:

Exclusion Criteria for Enrollment Phase:
• Pregnant and lactating women
• Treatment with prior systemic chemotherapy at any time
• Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years before enrollment
• Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days prior to enrollment
• Patients with hearing impairment
• Known sensitivity to any component of the chemotherapy regimen the patient will be assigned to, or to mannitol
• Prior treatment with an anti-PD-1, anti-PD-L1, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
• Interstitial lung disease or history of pneumonitis
• Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS > 90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
• Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the MPDL3280A formulation
• History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
• Positive test for HIV
• Patients with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C
• Active tuberculosis
• Significant cardiovascular disease, such as New York Heart Association cardiac disease(Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
• Prior allogeneic bone marrow transplantation or solid organ transplant
• Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications

Specific Exclusions for Pemetrexed Treatment:
• Patients with squamous cell histology
• Patients who are receiving concurrent nonsteroidal anti-inflammatory agents (NSAIDs) and are unable to discontinue treatment

Exclusion Criteria for Randomized Phase:
• Signs or symptoms of infection within 14 days prior to randomization (severe infection within 28 days prior to randomization), including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
• Received therapeutic oral or IV antibiotics within 14 days prior to randomization
• Major surgical procedure within 28 days prior to randomization or anticipation of need for a major surgical procedure during the course of the study
• Administration of a live, attenuated vaccine within 28 days prior to randomization or anticipation that such a live attenuated vaccine will be required during the study
• Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to randomization
• Uncontrolled or symptomatic hypercalcemia (> 1.5 mmol/L ionized calcium or calcium > 12 mg/dL or corrected serum calcium >ULN)
• For patients who are receiving denosumab prior to randomization, unwillingness or ineligibility to receive a bisphosphonate instead while in the study

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Lung Cancer
Open to Enrollment

A Phase IIIb/IV Safety Trial of Nivolumab (BMS-936558) in Subjects with Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving at Least One Prior Systemic Regimen

The purpose of this study is to estimate the incidence and characterize the outcome of high grade, select adverse events in subjects with advanced or metastatic NSCLC treated with Nivolumab.

Investigator:
Dennis Lowenthal, MD
CA209-153 | PHASE III

Sponsor:
Bristol-Myers Squibb Company - CT

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

1. Target Population
•Subjects with histologically-or cytologically-documented NSCLC [squamous (SQ) or nonsquamous (NSQ)] who present with Stage IIIB/Stage IV disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology), or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection or definitive chemoradiotherapy for locally advanced disease)
•Subjects must have experienced disease progression or recurrence during or after at least one systemic therapy for advanced or metastatic disease
•First line therapy is defined as therapy used to treat advanced disease. Each subsequent line of therapy is preceded by disease progression. A switch of an agent within a regimen in order to manage toxicity does not define the start of a new line of therapy
•Maintenance therapy following platinum doublet-based chemotherapy is not considered as a separate regimen of therapy
•Subjects who received platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, and developed recurrent (local or metastatic) disease within 6 months of completing therapy are eligible
•Subjects with recurrent disease >6 months after platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, who also subsequently progressed during or after a platinum doublet-based regimen given to treat the recurrence are eligible
•Subjects with progression or recurrent disease during or after Epithelial Growth Factor Receptor (EGFR) or Anaplastic Lymphoma Kinase (ALK) tyrosine kinase inhibitor (TKI) regimen are eligible
•Experimental therapies when given as separate regimen are considered as separate line of therapy
•Eastern Cooperative Oncology Arm (ECOG) performance status (PS)
•PS 0 to 1
•PS 2

Exclusion Criteria:
1. Target Disease Exceptions
◦Subjects with active central nervous system (CNS) metastases are excluded
◦Subjects with carcinomatous meningitis

2.Medical History and Concurrent Diseases
◦Subjects with a history of interstitial lung disease
◦Subjects with active, known or suspected autoimmune disease
◦Subject whom participated in either arm of the following clinical trials CA209-017, CA209-057, CA209-026, and CA184-104 or received prior treatment with anti-programmed death 1 (PD-1) or anti-programmed death-ligand 1 (PDL1) experimental agents

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Lung Cancer
Open to Enrollment

Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

This research trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients...

Investigator:
Missak Haigentz, MD

that have certain genetic changes.

A151216

Sponsor:
Alliance

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Inclusion Criteria:
• PATIENT PRE-REGISTRATION ELIGIBILITY CRITERIA:
• For pre-surgical patients
◦ Suspected diagnosis of resectable non-small cell lung cancer; cancers with a histology of "adenosquamous" are considered a type of adenocarcinoma and thus a "nonsquamous" histology; patients with squamous cell carcinoma are eligible only if the registering site has EA5142 Institutional Review Board (IRB) approved
◦ Suspected clinical stage of IIIA, II (IIA or IIB) or large IB (defined as size >= 4cm); Note: IB tumors < 4cm are NOT eligible; stage IB cancer based on pleural invasion is not eligible unless the tumor size is >= 4cm
• For post-surgical patients
◦ Completely resected non-small cell lung cancer with negative margins (R0); patients with squamous cell carcinoma are eligible only if the registering site has EA5142 IRB approved
◦ Pathologic stage IIIA, II (IIA or IIB) or large IB (defined as size >= 4 cm); Note: IB tumors < 4cm are NOT eligible; stage IB cancer based on pleural invasion is not eligible unless the tumor size is >= 4cm
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• No patients who have received neoadjuvant therapy (chemo- or radio-therapy) for this lung cancer
• No locally advanced or metastatic cancer requiring systemic therapy within 5 years prior to registration; no secondary primary lung cancer diagnosed concurrently or within 2 year prior to registration
• No prior treatment with agents targeting EGFR mutation, ALK rearrangement, and PD-1/PD-L1/CTLA-4
• No patients known to be pregnant or lactating
• Patients who have had local genotyping are eligible, regardless of the local result
• No patients with recurrence of lung cancer after prior resection
• Note: Post-surgical patients should proceed to registration immediately following preregistration
• PATIENT REGISTRATION ELIGIBILITY CRITERIA:
• Completely resected NSCLC with negative margins (R0); cancers with a histology of "adenosquamous" are considered a type of adenocarcinoma and thus a "nonsquamous" histology; patients with squamous cell carcinoma are eligible only if the registering site has EA5142 IRB approved
• Pathologic stage IIIA, IIA or IIB, or large IB (defined as size >= 4cm); Note: IB tumors < 4cm are NOT eligible; stage IB cancer based on pleural invasion is not eligible unless the tumor size is >= 4cm
• Tissue available for the required analyses (either clinical tissue block or slides and scrolls)
• In order to allow for time for central genotyping and eligibility for the ALCHEMIST treatment trial, patients must register within the following eligibility windows, depending on the adjuvant treatment approach:
◦ If no adjuvant therapy, register patient within 75 days following surgery
◦ If adjuvant chemotherapy or radiotherapy only, register patient within 225 days following surgery
◦ If adjuvant chemotherapy and radiation, register patient within 285 days following surgery

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Lung Cancer
Open to Enrollment

Adjuvant Nivolumab in Resected Lung Cancers (ANVIL)-A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-small Cell Lung Cancers

This randomized phase III trial studies how well nivolumab after surgery and chemotherapy work in treating patients with stage IB-IIIA non-small cell lung cancer. Monoclonal antibodies, such as nivolumab, may stimulate the immune system in different ways and...

Investigator:
Missak Haigentz, MD

kill tumor cells remaining after surgery and standard of care chemotherapy.

EA5142 | PHASE III

Sponsor:
Eastern Cooperative Oncology Group

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Patients must have undergone complete surgical resection of their stage IB (>= 4 cm), II or IIIA NSCLC according to the American Joint Committee on Cancer (AJCC) 7th edition and have had negative surgical margins
• Baseline chest computed tomography (CT) must be performed within 1 month (30 days) of randomization to ensure no evidence of disease; if clinically indicated, additional imaging studies must be performed to rule out metastatic disease
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization
• Non-squamous tumors must be epidermal growth factor receptor (EGFR) and anaplastic lymphoma receptor tyrosine kinase (ALK) wild-type (results ascertained in centrally as part of ALCHEMIST-SCREEN protocol)
• Tumors must have PD-L1 status tested centrally as part of the ALCHEMIST-SCREEN protocol
• Women must not be pregnant or breast-feeding
• All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
• Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse during the treatment period and for 31 weeks after the last nivolumab infusion
• Patients must NOT have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
• No prior treatment with an immune checkpoint inhibitor (anti-programmed cell death [PD]-1, anti-PD-L1, anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA4] monoclonal antibody)
• Patients must have adequately recovered from surgery and chemotherapy at the time of randomization
◦ Minimum time between date of surgery and randomization is 4 weeks (28 days)
◦ Maximum time allowed between surgery and randomization:
◾3 months (90 days) if no chemotherapy is administered
◾8 months (240 days) if adjuvant chemotherapy was administered
◾10 months (300 days) if adjuvant chemotherapy and radiation therapy was administered
• Patients must have completed and recovered from any adjuvant chemotherapy 2 or more weeks prior to randomization (6 weeks for mitomycin and nitrosoureas; 4 weeks for post-operative radiation therapy)
• Serum aspartate transaminase (aspartate aminotransferase [AST]) and serum alanine transaminase (alanine aminotransferase [ALT]) =< 2.5 x upper limit normal
• Total bilirubin =< 1.5 x upper limit of normal (ULN) (except in subjects with Gilbert syndrome who must have a total bilirubin < 3.0 x ULN)
• White blood cell (WBC) >= 2000/uL
• Neutrophils >= 1000/uL
• Platelets >= 100 x 10^3/uL
• Hemoglobin >= 8 g/dL
• Serum creatinine =< 2 x ULN
• Prior to randomization patients with any non-hematologic toxicity from surgery, chemotherapy and radiation therapy must have recovered to grade =< 1 with the exception of alopecia, ototoxicity and neuropathy
• Patients must not be receiving any other investigational anti-cancer agents while on study
• Patients must not have known or suspected autoimmune disease; subjects with type I diabetes mellitus, hypothyroidism requiring hormone replacement, or skin disorders not requiring systemic treatment are permitted to enroll
• Patients must not have a condition requiring systemic corticosteroids equivalent to > 10 mg prednisone per day or other immunosuppressive medications within 2 weeks of randomization
• Patients must not have known interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
• Patients must not have a known history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection that is untreated and/or with a detectable viral load
• Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab

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Lung Cancer
Open to Enrollment

Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice

This is an observational, multicenter study in patients treated with nivolumab for the approved indications of melanoma and lung cancer in Australia, the EU, Switzerland, and the United States (US). Targeted countries in the EU for study participation include...

Investigator:
Dennis Lowenthal, MD

Austria, Belgium, France, Germany, Italy, Spain, and the United Kingdom (UK). Study objectives are to assess the safety experience, survival, adverse event management, and outcomes of adverse events associated with nivolumab in routine oncology care facilities.

CA209-234

Sponsor:
Bristol-Myers Squibb Company - CT

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Probability Sample

Study Population:
The study population consists of 400 adults treated with nivolumab for histologically or cytologically confirmed melanoma and 800 adults treated with nivolumab for histologically or cytologically confirmed lung cancer in accordance with the approved indications in Australia, the EU, Switzerland, and the US. Target EU countries for patient enrollment include Austria, Belgium, France, Germany, Italy, Spain, and the UK. Patients who begin treatment with nivolumab for the first time will be enrolled in accordance with the approved indications and whose treatment strategy was determined independently from consideration of study participation. Treatment will be determined at the treating physician's discretion and with the patient's consent.

Inclusion Criteria:
• Age ≥18
• Histologically or cytologically confirmed diagnosis of melanoma (including uveal melanoma) or lung cancer
• Treatment with commercial nivolumab for the first time, alone or in combination with ipilimumab, for the approved indications of nivolumab within 14 days before informed consent for this study OR in the case where treatment has not yet been initiated, documentation that the treatment strategy is determined before an informed consent to study participation, and treatment is initiated within 28 days after informed consent

Exclusion Criteria:
• Prior participation in a clinical trial within the past 4 weeks
• Previously treated with anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies
• Previously treated with anti-CTLA-4 for lung cancer
• Current or pending participation in a clinical trial
• Current or pending systemic treatment for cancer other than melanoma and lung cancer
• Inability to comply with the study protocol

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Lung Cancer
Open to Enrollment

Randomized Study of Erlotinib vs Observation in Patients With Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)

This randomized phase III trial studies how well erlotinib hydrochloride compared to observation works in treating patients with stage IB-IIIA non-small cell lung cancer that has been completely removed by surgery. Erlotinib hydrochloride may stop the growth...

Investigator:
Missak Haigentz, MD

of tumor cells by blocking some of the enzymes needed for cell growth.

A081105 | PHASE III

Sponsor:
Alliance

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Previously registered to A151216, with the result of lung cancer harboring an EGFR exon 19 deletion or L858R mutation; the testing must have been performed by one of the following criteria:
1. Patient registered to A151216 and the assessment performed centrally by the protocol-specified laboratory
2. By a local Clinical Laboratory Improvement Amendments (CLIA) certified laboratory; the report must indicate the result as well as the CLIA number of the laboratory that performed the assay; these patients will also have been registered to A151216, but can be enrolled on A081105 regardless of the central lab results
◾ Patients with known resistant mutations in the EGFR tyrosine-kinase (TK) domain (T790M) are not eligible
◾ Patients that are both EGFR mutant and anaplastic lymphoma kinase (ALK) rearrangements will be registered to A081105
• Completely resected stage IB (>= 4 cm), II or IIIA non-squamous NSCLC with negative margins; patients may not have received neoadjuvant therapy (chemo- or radio-therapy) for this lung cancer
• Complete recovery from surgery and standard post-operative therapy (if required); patients must be completely recovered from surgery at the time of randomization; the minimum time requirement between date of surgery and randomization must be at least 28 days, the maximum time requirement between surgery and randomization must be 90 days if no adjuvant chemotherapy was administered, 240 days if adjuvant chemotherapy was administered, and 300 days if adjuvant chemotherapy and radiation therapy was administered
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• No locally advanced or metastatic cancer requiring systemic therapy within 5 years prior to registration; no secondary primary lung cancer diagnosed concurrently or within 2 years prior to registration
• Non-pregnant and non-lactating
• No history of cornea abnormalities
• Granulocytes >= 1,500/ul
• Platelets >= 100,000/ul
• Total bilirubin =< 1.5 x upper limit of normal (ULN)
• Serum glutamic oxaloacetic transaminase (SGOT) =< 1.5 x ULN
• Serum creatinine =< 1.5 x ULN

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Lung Cancer
Open to Enrollment

S1400 Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study "Master Protocol". The type of cancer...

Investigator:
Dennis Lowenthal, MD

trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a "non-match" sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.

S1400 | PHASE II/III

Sponsor:
Southwest Oncology Group

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• SCREENING REGISTRATION:
• Patients must have pathologically proven squamous cell non-small cell lung cancer (NSCLC) confirmed by tumor biopsy and/or fine-needle aspiration; disease must be either advanced, incurable stage IIIB or stage IV NSCLC; the primary diagnosis of SCCA should be established using the current World Health Organization (WHO)/International Association for the Study of Lung Cancer (IASLC)-classification of Thoracic Malignancies; the diagnosis is based on hematoxylin and eosin (H&E) stained slides with or without specific defined immunohistochemistry (IHC) characteristic (p40/p63 positive, transcription termination factor [TTF1] negative) if required for diagnosis; mixed histologies will be allowed provided that they contain >= 50% of the squamous component
• Patients must have progressed after receiving exactly one front-line platinum containing metastatic chemotherapy regimen
• Patients must have adequate tumor tissue available (defined as >= 20% tumor cells as confirmed by the treating institution's local pathologist); patients must agree to have this tissue submitted to Foundation Medicine for common broad platform Clinical Laboratory Improvement Amendments (CLIA) biomarker profiling; if archival tumor is used either a tumor block or at a minimum 12 formalin-fixed paraffin-embedded (FFPE) slides 4-5 microns thick are required, but 20 slides are strongly recommended; in the event that patient's archival tumor material is derived from a fine needle aspirate and the tumor material from fine needle aspirate or from core needle biopsy is exhausted a new fresh tumor biopsy will be obtained and will be formalin fixed and paraffin-embedded
• Patients must not have a known epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) fusion; in addition, patients whose biomarker profiling results indicate the presence of an EGFR mutation or ALK fusion will be notified that they are not eligible for any of the sub-studies
• Patients must have Zubrod performance status =< 2 documented within 28 days prior to screening registration
• Patients must also be offered participation in banking for future use of specimens
• Patients must be willing to provide prior smoking history
• Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
• As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

• SUB-STUDY ASSIGNMENT:
• Patients whose biomarker profiling results indicate the presence of an EGFR mutation or echinoderm microtubule-associated protein-like 4 (EML4)/ALK fusion are not eligible
• Patients must be registered to the assigned sub-study within 28 calendar days of receiving sub-study assignment from the statistical center
• Patients must have measurable disease, documented by computed tomography (CT) or magnetic resonance imaging (MRI); the CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality; if patient has measurable disease it must assessed within 28 days prior to sub-study treatment arm randomization; pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease; non-measurable disease must be assessed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form; patients with active new disease growth in previously irradiated site are eligible
• Patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study treatment arm randomization; patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 28 days following treatment, AND (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 14 days prior to randomization
• Patients must have progressed after receiving exactly one front-line platinum containing metastatic chemotherapy regimen; patients must not have received any prior systemic chemotherapy or investigational drug within 21 days prior to sub-study treatment arm randomization; patients must have recovered (=< grade 1) from any side effects of prior therapy; localized palliative radiotherapy >= 14 days is allowed
• Patient must have fully recovered from the effects of prior surgery prior to sub-study treatment arm randomization
• Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable
• Absolute neutrophil count (ANC) >= 1,500/mcl obtained within 28 days prior to sub-study treatment arm randomization
• Platelet count >= 100,000 mcl obtained within 28 days prior to sub-study treatment arm randomization
• Hemoglobin >= 9 g/dL obtained within 28 days prior to sub-study treatment arm randomization
• Serum bilirubin =< 2 X institutional upper limit of normal (IULN) within 28 days prior to sub-study treatment arm randomization
• Either serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transferase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x IULN within 28 days prior to sub-study treatment arm randomization (if both SGOT and SGPT are done, both must be =< 2 IULN)
• For patients with liver metastases, bilirubin and either SGOT and SGPT must be =< 5 x IULN
• Serum creatinine =< the IULN OR measured or calculated creatinine clearance >= 50 cc/min using the following Cockroft-Gault Formula within 28 days prior to sub-study treatment arm randomization
• Patients must have Zubrod performance status =< 2 documented within 28 days prior to sub-study treatment arm randomization
• Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
• Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection
• Patients must not have a known history of human immunodeficiency virus (HIV) seropositivity
• Prestudy history and physical must be obtained within 28 days prior to sub-study treatment arm randomization
• No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
• Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures

S1400A:
• Patients must not have any prior exposure to immunotherapy such as, but not limited to other anti-cytotoxic T lymphocyte antigen 4 (CTLA-4), anti-programmed cell death (PD)-1, or anti-PD-L1 antibodies excluding vaccines within 28 days prior to sub-study treatment arm randomization
• Patients must not have received or be planning to receive any anti-cancer therapy whether chemotherapy, or biologic therapy, therefore receipt of the last dose of anti-cancer therapy, (chemotherapy, endocrine therapy, targeted therapy, biologic therapy, or tumor embolization) > 21 days prior to randomization (> 14 days prior to randomization for patients who have received prior TKIs [e.g. erlotinib, gefitinib, or crizotinib] and > 42 days for nitrosoureas or mitomycin-c)
• Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable; patients must not have received or be planning to receive any immunosuppressive medication within 28 days prior to sub-study treatment arm randomization, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
• Patients must not have any active or prior documented autoimmune or inflammatory disease (including inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease, irritable bowel disease; Wegner syndrome; Hashimoto syndrome) within 3 years prior to sub-study treatment arm randomization; patients with vitiligo, alopecia, Grave's disease, or psoriasis not requiring systemic treatment (within the past 3 years) are not excluded
• Patients must not have any history of primary immunodeficiency
• Patients must not have any prior grade >= 3 immune-related adverse event (irAE) or any unresolved irAE > grade 1
• Patients must not have any history of organ transplant that requires use of immunosuppressives
• Patients must not have any known allergy or reaction to any component of the MEDI4736 formulation
• Patients must not have a known history of tuberculosis
• Patients must not have received a live attenuated vaccination within 28 days prior to sub-study treatment arm randomization
• Patients must not have known HIV, hepatitis B or C positivity

S1400B:
• Hemoglobin A1c (HbA1c) < 7% obtained within 28 days prior to sub-study treatment arm randomization
• Fasting glucose < 125 mg/dl obtained within 28 days prior to sub-study treatment arm randomization
• Patients must not have Type 1 or 2 diabetes which requires insulin
• Patients must not have active or a history of small or large intestine inflammation such as Crohn's disease or ulcerative colitis
• Patients must not require daily supplemental oxygen
• Patients must be able to take oral medications; patients may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of GDC-0032 (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
• Patients must not be taking, nor plan to take while on protocol treatment and for 14 days post the last dose of study treatment, drugs, herbal supplements or foods that are known to be strong/moderate cytochrome p450, family 3, subfamily A, polypeptide 4 (CYP3A4) substrates
• Patients must not have received prior treatment of docetaxel as part of frontline platinum-containing chemotherapy (S1400B)

S1400C:
• Patients must not be taking within 7 days prior to sub-study treatment arm randomization, nor plan to take while on protocol treatment, CYP3A4 inhibitors and/or strong CYP3A4 inducers; moderate inhibitors or inducers of isoenzyme CYP3A4 should be avoided, but if necessary can be used with caution
• Patients must not be taking within 7 days prior to sub-study treatment arm randomization, nor plan to take while on protocol treatment drugs that are known to prolong the QT interval
• Patients must not have QTc > 480msec (based on the mean value of the triplicate electrocardiograms [ECGs]), family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes
• Patients must not have uncontrolled electrolyte disorders which can compound the effects of a QTc-prolonging drug (eg, hypocalcemia, hypokalemia, hypomagnesemia)
• Patients must be able to take oral medications; patient may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of palbociclib (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
• Patients must not have received prior treatment of docetaxel as part of frontline platinum-containing chemotherapy (S1400C)

S1400D:
• Patients must be >= 25 years of age (skeleton maturation is complete)
• Patients must not be taking, nor plan to take while on protocol treatment and for 14 days after the last dose of study treatment drugs, herbal supplements and/or foods known to modulate CYP3A4 or cytochrome p450, family 2, subfamily D, polypeptide 6 (CYP2D6) enzyme activity and drugs that are known to be CYP3A4 substrates
• Patients must not have received Nitrosourea or mitomycin C within 42 days prior to sub-study treatment arm randomization
• Patients must not have had any prior exposure to any agent with FGFR inhibition as its primary pharmacology
• Patients must not have a mean resting corrected QT interval (QTc) > 450 msec obtained from 3 consecutive electrocardiograms (ECGs); any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block); nor any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval
• Patients must be able to take oral medications; patient may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of AZD4547 (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
• Patients must not have a history of hypersensitivity to active or inactive excipients of AZD4547 or drugs with a similar chemical structure or class to AZD4547

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Lung Cancer
Open to Enrollment

The FAMRI-IELCAP Collaborative Network to study Health Effects of Secondhand Smoke Exposure

This study explores the early detection and treatment of lung cancer and other diseases associated with secondhand smoke exposure through the use of low-dose computed tomography (CT) screening.

Investigator:
Mark Widmann, MD
FAMRI-IELCAP

Sponsor:
Icahn School of Medicine at Mount Sinai

Inclusion & Exclusion Criteria:
Inclusion:
• Asymptomatic never smokers who have been exposed to secondhand smoke
• 40 years old and over

Exclusion:
• Pregnant women
• CT chest scan in the past 3 years
• Lung cancer or symptoms of lung cancer (hemoptysis, worsening cough with hoarseness, unexplained loss of weight)
• Other metastatic cancer (prophylactic treatment is acceptable)

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Lupus
Open to Enrollment

A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects With Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects With Active Cutaneous Lupus Erythematosus With or Without Systemic Manifestations

The primary objective of the study is to evaluate the efficacy of BIIB059 in reducing skin disease activity in participants with systemic lupus erythematosus (SLE) (Part A), and in participants with active cutaneous lupus erythematosus (CLE) with or without...

Investigator:
Neil Kramer, MD

systemic manifestations (Part B), and to investigate the dose response relationship in participants with active SLE and skin manifestations (Part A only). Secondary objective is to evaluate additional efficacy parameters of BIIB059 in reducing SLE disease activity.

230LE201 | PHASE II

Sponsor:
Biogen MA Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Key Inclusion Criteria:
1. All women of childbearing potential and all men must practice effective contraception during the study and for 4 months after their last dose of study treatment.
2. CLASI-A ≥ 8 at Screening and Randomization.

Key Exclusion Criteria:
1. Active lupus nephritis or moderate-to-severe or chronic kidney disease.
2. Any active skin conditions other than CLE that may interfere with the study (e.g., psoriasis, non-LE skin lupus, drug-induced lupus).
3. History of chronic, recurrent, or recent serious infection.
4. Active clinically significant viral, bacterial, or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks of or during Screening, or completion of oral anti-infectives within 2 weeks before or during Screening.
5. Use of immunosuppressive or disease-modifying treatments for SLE that were initiated less than 3 months prior to Screening.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

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Lupus
Open to Enrollment

A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Effect of BI 655064 Administered as Sub-cutaneous Injections, on Renal Response After One Year Treatment in Patients With Lupus Nephritis

The overall purpose of the study is to assess the efficacy of three different doses of BI 655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus nephritis in order to characterize the dose-response relationship within...

Investigator:
Neil Kramer, MD

the therapeutic range, and select the target dose for phase III development.

1293.10 | PHASE II

Sponsor:
Boehringer Ingelheim Pharmaceuticals Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion criteria:
• Males and females 18-70 years. Women of childbearing potential must be ready and able to use highly effective methods of birth control per international Conference on Harmonisation M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
• Diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology criteria 1997, at least 4 criteria must be documented, one of which must be a positive anti-dsDNA antibody
• Lupus Nephritis Class III or IV (International Society of Nephrology (ISN)/Renal Pathology Society (RPS) -2003 classification) with either active or active/chronic disease, co-existing class V permitted, proven by renal biopsy within 3 months prior to screening or during screening if induction therapy has not yet been started
• Active renal disease evidenced by proteinuria >= 1.0 g/day (Uprot/Ucrea >= 100 mg/mmol)
• Signed and dated written informed consent

Exclusion criteria:
• Clinically significant current other renal disease
• Glomerular Filtration Rate <30ml/min/1.73m²
• Acute presence of Oliguria (<500 mL/day)
• Dialysis within 12m of screening
• Antiphospholipid syndrome
• Diabetes mellitus poorly controlled or known diabetic retinopathy or nephropathy
• Evidence of current or previous clinically significant disease, medical condition or finding in the medical examination that in the investigator's opinion would compromise the safety of the patient or the quality of the data
• Any induction therapy for Lupus Nephritis within the last 6 months prior to randomisation except induction with Mycophenolate Mofetil and high dose steroids started within 4 weeks prior to randomisation
• Treatment with any biologic B-cell depleting therapy (e.g. anti-CD20, anti-CD22, anti-BLyS) within 12 months prior to randomisation
• Treatment with abatacept within 12 months prior to randomisation
• Treatment with tacrolimus or cyclosporin within 4 weeks prior to randomisation
• Treatment with cyclophosphamid within 6 months prior to randomisation
• Treatment with investigational drug within 6 months or 5 half-lives, whichever is greater before randomisation
• Contraindication for MMF or corticosteroids
• Chronic or relevant acute infections, including but not limited to HIV, Hepatitis B and C and tuberculosis (including a history of clinical tuberculosis (TB) and/or a positive QuantiFERON TB-Gold test
• Any active or suspected malignancy or history of documented malignancy within the last 5 years before screening, except appropriately treated carcinoma in situ and treated basal cell carcinoma.
• Live vaccination within 6 weeks before randomisation
• Patients unable to comply with the protocol in the investigator's opinion.
• Alcohol abuse in the opinion of the investigator or active drug abuse .
• Women who are pregnant, nursing, or who plan to become pregnant while in the trial
• Impaired hepatic function, defined as serum Aspartate Transferase/Alanine Transferase, bilirubin or alkaline phosphatase levels > 2 x Upper Limit of Normal

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Mitral Valve
Open to Enrollment

Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk Patients (The COAPT Trial)

The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation(COAPT) Trial is to confirm the safety and effectiveness of the MitraClip System for the treatment of...

Investigator:
Robert Kipperman, MD

moderate-to-severe or severe functional mitral regurgitation (FMR) in Symptomatic Heart Failure Subjects.

COAPT

Sponsor:
Evalve, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Symptomatic functional MR (≥3+) due to cardiomyopathy of either ischemic or non-ischemic etiology determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within 180 days prior to subject registration, with MR severity based principally on the TTE study, and must be confirmed by the Echocardiography Core Lab (ECL). The ECL may request a transesophageal echocardiogram (TEE) to confirm MR etiology.
Note: Functional MR requires the presence of global or regional left ventricular wall motion abnormalities, which are believed to be the primary cause of the MR. If a flail leaflet or other evidence of degenerative MR is present, the subject is not eligible even if global or regional left ventricular systolic dysfunction is present.
Note: Qualifying TTE must be obtained after the subject has been stabilized on optimal therapy and at least 30 days after:
a.any change in guideline-directed medical therapy
b.revascularization and/or implant of Cardiac Resynchronization Therapy device (CRT or CRT-D) or reprogramming of an implanted CRT or CRT-D that results in increased biventricular pacing (from <92% to ≥92%)

2. In the judgment of the HF specialist investigator at the site, the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, mitral regurgitation and heart failure (e.g., with cardiac resynchronization therapy, revascularization, and/or optimal medical therapy as appropriate. The Eligibility Committee must also concur that the subject has been adequately treated.
3. New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
4.The Local Site Heart Team (CT surgeon and HF specialist investigators) and the Central Eligibility Committee concur that surgery will not be offered as a treatment option and that medical therapy is the intended therapy for the subject, even if the subject is randomized to the Control group.
5.The subject has had at least one hospitalization for heart failure in the 12 months prior to subject registration and/or a corrected brain natriuretic peptide (BNP) ≥300 pg/ml or corrected n-Terminal pro- brain natriuretic peptide NT-proBNP ≥1500 pg/ml measured within 90 days prior to subject registration ("corrected" refers to a 4% reduction in the BNP or NT-proBNP cutoff for every increase of 1 kg/m2 in BMI above a reference BMI of 20 kg/m2).
Note: BNP or NT-proBNP must be obtained after the subject has been stabilized on optimal therapy and at least 30 days after:
a. any change in guideline-directed medical therapy
b. revascularization and/or implant of Cardiac Resynchronization Therapy device (CRT or CRT-D) or reprogramming of an implanted CRT or CRT-D that results in increased biventricular pacing (from <92% to ≥92%).
6. Left Ventricular Ejection Fraction (LVEF) is ≥20% and ≤50% within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI).
7.The primary regurgitant jet is non-commissural, and in the opinion of the MitraClip implanting investigator can be successfully be treated by the MitraClip. If a secondary jet exists, it must be considered clinically insignificant.
8. Creatine Kinase-MB (CK-MB) obtained within prior 14 days < local laboratory Upper Limit of Normal (ULN).
9. Transseptal catheterization and femoral vein access is determined to be feasible by the MitraClip implanting investigator.
10. Age 18 years or older.
11. The subject or the subject's legal representative understands and agrees that should he/she be assigned to the Control group, he/she will be treated with medical therapy and conservative management without surgery and without the MitraClip, either domestically or abroad. If the subject would actively contemplate surgery and/or MitraClip if randomized to Control, he/she should not be registered in this trial.
12. The subject or the subject's legal representative has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent.

Exclusion Criteria:
1. Untreated clinically significant coronary artery disease requiring revascularization.
2. Coronary artery bypass grafting (CABG) within 30 days prior to subject registration.
3. Percutaneous coronary intervention within 30 days prior to subject registration.
4. Tricuspid valve disease requiring surgery.
5. Aortic valve disease requiring surgery.
6. Cerebrovascular accident within 30 days prior to subject registration.
7. Severe symptomatic carotid stenosis (> 70% by ultrasound).
8. Carotid surgery within 30 days prior to subject registration.
9. American College of Cardiology /American Heart Association (ACC/AHA) Stage D heart failure.
10. Presence of any of the following:
◦Estimated pulmonary artery systolic pressure (PASP) > 70 mm Hg assessed by site based on echocardiography or right heart catheterization, unless active vasodilator therapy in the cath lab is able to reduce the pulmonary vascular resistance (PVR) to < 3 Wood Units or between 3 and 4.5 Wood Units with v wave less than twice the mean of the pulmonary capillary wedge pressure
◦Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non ischemic etiology
◦Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis)
◦Hemodynamic instability requiring inotropic support or mechanical heart assistance.

11. Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction.
12. Implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) within the last 30days prior to subject registration.
13. Mitral valve orifice area < 4.0 cm2 assessed by site based on a transthoracic echocardiogram (TTE) within 90 days prior to subject registration.
14. Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip. This evaluation is based on transesophageal echocardiogram (TEE) evaluation of the mitral valve within 180 days prior to subject registration and includes:
◦Insufficient mobile leaflet available for grasping with the MitraClip device
◦Evidence of calcification in the grasping area
◦Presence of a significant cleft in the grasping area
◦Lack of both primary and secondary chordal support in the grasping area
◦Leaflet mobility length < 1 cm

15. Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device.
16. Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
17. Life expectancy < 12 months due to non-cardiac conditions.
18. Modified Rankin Scale ≥ 4 disability.
19. Status 1 heart transplant or prior orthotopic heart transplantation.
20. Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure.
21. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
22. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated).
23. Active infections requiring current antibiotic therapy.
24. Subjects in whom transesophageal echocardiography (TEE) is contraindicated or high risk.
25. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically.
26. Pregnant or planning pregnancy within next 12 months.
Note: Female patients of childbearing age should be instructed to use safe contraception (e.g. intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release. It is accepted in certain cases to include subjects having a sterilized regular partner or subjects using a double barrier contraceptive method. However, this should be explicitly justified in special circumstances arising from the study design, product characteristics and/or study population.

27. Currently participating in an investigational drug or another device study that has not reached its primary endpoint. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
28. Subject belongs to a vulnerable population per investigator's judgment or subject has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures.

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Multiple Myeloma
Open to Enrollment

A Phase III Study of Pomalidomide and Low Dose Dexamethasone With or Without Pembrolizumab (MK3475) in Refractory or Relapsed and Refractory Multiple Myeloma (rrMM) (KEYNOTE 183)

The purpose of this study is to compare the efficacy of pomalidomide and low dose dexamethasone with pembrolizumab (MK-3475) to that of pomalidomide and low dose dexamethasone without pembrolizumab in terms of Progression-Free Survival (PFS) in participants...

Investigator:
Neil Morganstein, MD

with refractory or relapsed and refractory multiple myeloma (rrMM) who have undergone at least 2 lines of prior treatment.

MK-3475-183 | PHASE III

Sponsor:
Merck, Sharpe & Dohme, Corp.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Has a confirmed diagnosis of active multiple myeloma and measurable disease
• Must have undergone prior treatment with ≥2 treatment lines of anti-myeloma therapy and must have failed last line of treatment (refractory to last line of treatment)
• Prior anti-myeloma treatments must have included an immunomodulatory drug (IMiD) AND proteasome inhibitor alone or in combination and participant must have failed therapy with an IMiD OR proteasome inhibitor
• Has performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
• Female participants of childbearing potential must have 2 negative urine human chorionic gonadotropin tests within 10 to 14 days and within 24 hours prior to receiving study medication
• Female participants of childbearing potential and male participants must agree to use adequate contraception 28 days prior to study start and continuing for up to 28 days after the last dose of pomalidomide (or 120 days after the last dose of pembrolizumab)

Exclusion Criteria:
• Has had prior anti-myeloma therapy within 2 weeks prior to study start and has not recovered (i.e., ≤ Grade 1 or at Baseline) from adverse events due to a previously administered agent
• Has undergone prior allogeneic hematopoetic stem cell transplantation within the last 5 years. (Participants who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of Graft versus Host Disease [GVHD]).
• Has received autologous stem cell transplant (auto-SCT) within 12 weeks before the first infusion or is planning for or is eligible for auto-SCT
• Has received previous therapy with pomalidomide
• Has peripheral neuropathy ≥ Grade 2
• Has a known additional malignancy that is progressing or requires active treatment within the last 5 years (except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy)
• Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
• Has received prior therapy with an anti-programmed cell death 1 receptor (anti-PD-1), antiprogrammed death-ligand 1 (anti-PD-L1), anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways)
• Is pregnant or breast-feeding

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Multiple Myeloma
Open to Enrollment

Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma

This randomized phase II/III trial studies how well lenalidomide works and compares it to observation in treating patients with asymptomatic high-risk asymptomatic (smoldering) multiple myeloma. Biological therapies such as lenalidomide, may stimulate the...

Investigator:
Neil Morganstein, MD

immune system in different ways and stop cancer cells from growing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether lenalidomide is effective in treating patients with high-risk smoldering multiple myeloma than observation alone.

E3A06 | PHASE II/III

Sponsor:
Eastern Cooperative Oncology Group

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:

- Patients must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 60 months, as confirmed by both of the following:
- Bone marrow plasmacytosis with >= 10% plasma cells or sheets of plasma cells at any time before initiating study treatment, including a marrow which must be obtained by bone marrow aspiration and/or biopsy within 4 weeks prior to randomization
- Abnormal serum free light chain ratio (< 0.26 or > 1.65) by serum free light chain (FLC) assay; FLC assay must be performed within 28 days of randomization
- Patients must have measurable levels of monoclonal protein (M-protein): >= 1g/dL on serum protein electrophoresis or >= 200 mg of monoclonal protein on a 24 hour urine protein electrophoresis which must be obtained within 4 weeks prior to randomization
- Patients must have no lytic lesions on skeletal surveys and no hypercalcemia (i.e., >= 11 mg/dL)
- Hemoglobin >= 11 g/dL
- Platelet count >= 100,000/mm^3
- Absolute neutrophil count (ANC) >= 1,500/mm^3
- Calculated creatinine clearance >= 30 mL/min
- Bilirubin =< 1.5 mg/dL
- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) and serum glutamic oxaloacetic transaminase (SGPT) (aspartate aminotransferase [AST]) =< 2.5 times upper limit of normal
- No prior or concurrent systemic or radiation therapy for the treatment of myeloma
- Concurrent use of bisphosphonates is not permitted; however, prior bisphosphonates or once-a-year intravenous bisphosphonate given for the treatment of osteoporosis is permitted
- Prior or concurrent use of erythropoietin is disallowed
- Prior glucocorticosteroid therapy for the treatment of multiple myeloma is not permitted
- Prior systemic glucocorticosteroid use for the treatment of non-malignant disorders is permitted; concurrent use after registration on the study should be restricted to the equivalent of prednisone 10 mg per day
- Prior or concurrent topical or localized glucocorticosteroid therapy to treat non-malignant comorbid disorders is permitted
- Patients must not have active, uncontrolled seizure disorder; patients must have had no seizures in the last 6 months
- Patients must not have uncontrolled intercurrent illness including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would limit compliance with the study, or a prior history of Stevens Johnson Syndrome
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Patients must not have baseline bone lesions or plasmacytomas
- Patients with monoclonal gammopathy of undetermined significance are not eligible
- Patients must not have grade 2 or higher peripheral neuropathy
- Patients must not have active, uncontrolled infection
- Patients may have a history of current or previous deep vein thrombosis or pulmonary embolism but are required to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation
- Patients should not have New York Heart Association classification III or IV heart failure
- Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for cure of the specific cancer; for most diseases this time frame is 5 years
- Patients should not be felt to have an immediate need for chemotherapy
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting cycle 1 of lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; a FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure

-Human immunodeficiency virus (HIV) infection is not excluded; HIV+ patients must meet the following criteria:
Cluster of differentiation (CD)4 cell count >= 350/mm^3
No history of acquired immune deficiency syndrome (AIDS)-related illness
Not currently prescribed zidovudine or stavudine

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Neonatology
Open to Enrollment

A Multicenter, Randomized, Open-Label, Controlled Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Preterm Neonates

The primary objective of this study is to evaluate the safety and tolerability of a single exposure of aerosolized surfactant, specifically lucinactant for inhalation, administered in escalating inhaled doses to preterm neonates 29 to 34 weeks gestational...

Investigator:
John Ladino, MD

age who are receiving nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS), compared to neonates receiving nCPAP alone.

03-CL-1201 | PHASE II

Sponsor:
Discovery Laboratories, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: up to 21 Hours
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
•Informed consent from a legally authorized representative
•Gestational age 29 to 34 completed weeks (34 weeks 6 days) post menstrual age (PMA)
•Successful implementation of controlled nCPAP within 60 minutes after birth
•Spontaneous breathing
•Chest radiograph consistent with RDS
•Need for moderate levels of supplemental oxygen and nCPAP to maintain oxygen saturation of 88% to 95% for at least 60 minutes within the first 21 hours after birth

Exclusion Criteria:
•Heart rate that cannot be stabilized above 100 beats/minute within 5 minutes of birth
•Recurrent episodes of apnea occurring after the initial newborn resuscitation period (ie, 10 minutes after birth) requiring intermittent positive pressure breaths using inflating pressures above the set CPAP pressure administered manually or mechanically through any patient interface
•A 5 minute Apgar score < 5
•Major congenital malformation(s) and cranial/facial abnormalities that preclude nCPAP, diagnosed antenatally or immediately after birth
•Other diseases or conditions potentially interfering with cardiopulmonary function (eg, hydrops fetalis or congenital infection such as TORCH)
•Known or suspected chromosomal abnormality or syndrome
•Prolong rupture of membranes (PROM) > 2 weeks
•Evidence of hemodynamic instability requiring vasopressors or steroids for hemodynamic support
•Need for endotracheal intubation and mechanical ventilation
•Has been administered: another investigational agent or exposure to a medical device, any other surfactant agent, steroid treatment after birth

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Ovarian Cancer
Open to Enrollment

A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Niraparib in Women With Advanced, Relapsed, High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Received at Least Three Previous Chemotherapy Regimens

This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received at least three previous chemotherapy regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered...

Investigator:
Nana Tchabo, MD

once daily continuously during a 28-day cycle. Health-related quality of life will be measured by Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.

PR-30-5020-C | PHASE II

Sponsor:
Tesaro Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Female
Accepts Healthy Volunteers: No

Inclusion Criteria:

- Patients of childbearing potential must have negative pregnancy serum test within 72 hours of being dosed
- Histologically diagnosed recurrent high-grade serous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
- Must have completed at least 3 previous chemotherapy regimens
- ECOG 0-1
- Adequate bone marrow, kidney and liver function

Exclusion Criteria:

- Known hypersensitivity to the components of niraparib
- Symptomatic uncontrolled brain metastasis
- Invasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated)
- Is pregnant or breast feeding
- Immunocompromised patients
- Known active hepatic disease

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Ovarian Cancer
Open to Enrollment

A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP Inhibitor) in Subjects With Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

The focus of this study is to evaluate the efficacy, safety, and tolerability of veliparib in women with previously untreated, Stage III or IV, high-grade serous, epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Investigator:
Paul Heller, MD
M13-694 | PHASE III

Sponsor:
AbbVie, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 99 Years
Genders Eligible for Study: Female
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Histologic diagnosis of International Federation of Gynecology and Obstetrics (FIGO) Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, with the appropriate tissue available for histologic evaluation.
2. High-grade serous adenocarcinoma
3. Willing to undergo testing for gBRCA.
4. Adequate hematologic, renal, and hepatic function.
5. Neuropathy (sensory and motor) less than or equal to Grade 1.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
7. Participants who undergo primary cytoreductive surgery must be entered between 1 and 12 weeks after surgery. Participants undergoing interval surgery must have a tumor sample confirming the histological diagnosis prior to enrollment.
8. Participants with measurable disease and non-measurable disease are eligible. Participants may or may not have cancer-related symptoms.
9. Participant has one of the following available for PD analyses including somatic BRCA testing: Archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue; or tumor tissue biopsy collected prior to Cycle 1 Day 1.

Exclusion Criteria:
1. Endometrioid adenocarcinoma, carcinosarcoma, undifferentiated carcinoma, mixed epithelial adenocarcinoma, adenocarcinoma not otherwise specified, mucinous adenocarcinoma, clear cell adenocarcinoma, low-grade serous adenocarcinoma, or malignant Brenner's tumor.
2. Participants with synchronous primary endometrial cancer, or a past history of endometrial cancer unless all of the following conditions are met: endometrial cancer stage not greater than IA, no vascular or lymphatic invasion, no poorly differentiated subtypes including serous, clear cell, or other FIGO grade 3 lesions.
3. Participants with any evidence of other invasive malignancy being present within the last 3 years (with the exception of non-melanoma skin cancer). Participants are also excluded if their previous cancer treatment contraindicates this protocol's therapy.
4. Received prior radiotherapy to any portion of the abdominal cavity or pelvis.
5. Received prior chemotherapy for any abdominal or pelvic tumor.
6. Clinically significant uncontrolled condition(s).
7. Known history of allergic reaction to Cremophor-paclitaxel, carboplatin, Azo-Colourant Tartrazine (also known as FD&C Yellow 5 or E102), Azo-Colourant Orange Yellow-S (also known as FD&C Yellow 6 or E110) or known contraindications to any study supplied drug.
8. History or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) within 6 months of Cycle 1 Day 1.

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Ovarian Cancer
Open to Enrollment

A phase 3 randomized double-blind trial of maintenance with Niraparib versus placebo in patients with Platinum Sensitive Ovarian Cancer

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their...

Investigator:
Nana Tchabo, MD

most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values.

PR-30-5011-C | PHASE III

Sponsor:
Tesaro Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Female
Accepts Healthy Volunteers: No

Inclusion Criteria:
•18 years of age or older, female, any race
•Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal cancer
•High grade (or grade 3) serous histology or known to have gBRCAmut
•Has received at least 2 previous courses of platinum-containing therapy, and has disease that was considered platinum sensitive following the penultimate (next to last) platinum course (more than 6 month period between penultimate platinum regimen and progression of disease)
•Has response to last the platinum regimen, remains in response and is enrolled on study within 8 weeks of completion of the last platinum regimen
•ECOG 0-1
•Adequate bone marrow, kidney and liver function

Exclusion Criteria:
•Known hypersensitivity to the components of niraparib
•Invasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated)
•Symptomatic uncontrolled brain metastasis
•Is pregnant or breast feeding
•Immunocompromised patients
•Known active hepatic disease
•Prior treatment with a known PARP inhibitor

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Ovarian Cancer
Open to Enrollment

A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physician's Choice Single Agent Chemotherapy in the Treatment of Platinum Sensitive Relapsed Ovarian Cancer in Patients Carrying Germline BRCA1/2 Mutations

Comparison of olaparib vs. physician's choice of single agent standard of care non-platinum based chemotherapy in patients with germline Breast Cancer susceptibility gene (gBRCA) mutated ovarian cancer who have progressed at least 6 months after the last platinum...

Investigator:
Nana Tchabo, MD

based chemotherapy. Patient should have received at least 2 prior lines of platinum based chemotherapy. The aim of the study is to assess the efficacy and safety of olaparib tablets.

SOLO3 | PHASE III

Sponsor:
AstraZeneca

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Female
Accepts Healthy Volunteers: No

Inclusion Criteria:
- Patients must be ≥ 18 years of age
- Patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer
- Documented germline mutation in Breast Cancer susceptibility genes: BRCA1 and/or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)
- At least one lesion that can be accurately assessed at baseline by CT/MRI and is suitable for repeated assessment.
- Patients must have received at least 2 prior platinum based lines of chemotherapy - Patients must be partially platinum sensitive or platinum sensitive
- Patients must be suitable to start treatment with single agent chemotherapy based on physician's choice
- Patients must have normal organ and bone marrow function measured within 28 days of randomisation,
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patients must have a life expectancy ≥ 16 weeks
- Formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing.

Exclusion Criteria:
- BRCA 1 and/or BRCA2 mutations that are considered to be non detrimental
- Exposure to any investigational product within 30 days or 5 half lives (whichever is longer) prior to randomisation
- Any previous treatment with a Polyadenosine 5'diphosphoribose polymerisation (PARP) inhibitor, including olaparib.
- Patients who have platinum resistant or refractory disease
- Patients receiving any systemic chemotherapy within 3 weeks prior to first dose of study treatment
- Previous single agent exposure to the selected chemotherapy regimen for randomisation. - Prior malignancy in the last 5 years, unless curatively treated and recurrence free (few exceptions apply).

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Ovarian Cancer
Open to Enrollment

A Randomized, Open-Label Study Comparing the Combination of YONDELIS and DOXIL/CAELYX With DOXIL/CAELYX Monotherapy for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

The purpose of this study is to assess the efficacy and safety of trabectedin+DOXIL as a third-line chemotherapy regimen (treatment) in patients with platinum-sensitive advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer who...

Investigator:
Paul Heller, MD

received 2 previous lines of platinum-based chemotherapy.

ET743-OVC-3006 | PHASE III

Sponsor:
Janssen R & D

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Female
Accepts Healthy Volunteers: No

Inclusion Criteria:
•Histologically proven advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer
•Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
•Received first-line treatment with a platinum-based regimen and had no evidence of disease progression for 6 months after the last dose
•Received second-line treatment with a platinum-based regimen, with progression of disease after attaining a complete response (CR) or partial response (PR)
•Progression of disease based on imaging after the second-line platinum-based regimen (individuals treated with a pegylated liposomal doxorubicin-containing regimen as a second-line therapy are eligible if subsequent disease progression occurs >=9 months from the first dose)
•Evidence of measurable disease at screening as evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
•Able to receive intravenous (IV) dexamethasone or an equivalent IV corticosteroid
•Have a known BRCA 1/2 mutation status (for participants who do not have a known BRCA 1/2 status at screening, a blood sample will be collected to determine the status with the results available prior to randomization
•Laboratory values within protocol -defined parameters
•Have left ventricular ejection fraction by multigated acquisition scan (MUGA) scan or 2D-ECHO within normal limits for the institution
•Have side effects (except alopecia) of prior treatment resolved to at least Grade 1 according to the National Cancer Institute - Common Terminology Criteria of Adverse Events (NCICTCAE) (Version 4.0)
•Have a negative urine or serum pregnancy test at screening
•Agrees to protocol-defined use of effective contraception

Exclusion Criteria:
•Diagnosis of ovarian carcinoma with mucinous histology
•Had more than 2 prior lines of chemotherapy
•Prior exposure to trabectedin or hypersensitivity to any of the excipients
•Prior treatment with doxorubicin or other anthracycline at cumulative doses greater than 300 mg/m2 (calculated using doxorubicin equivalent doses: 1 mg doxorubicin = 1 mg Doxil/Caelyx = 1.8 mg epirubicin = 0.3 mg mitoxantrone = 0.25 mg idarubicin)
•Unwilling or unable to have a central venous catheter placed
•Pregnant or breast-feeding
•Less than 3 weeks from radiation therapy, experimental therapy, hormonal therapy, prior chemotherapy, or biological therapy
•History of another neoplastic disease (except non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin or cervical carcinoma in situ adequately treated) unless in remission for 5 years
•Known allergies, hypersensitivity, or intolerance to Doxil, dexamethasone, or their excipients
•Known history of central nervous system metastasis
•Known significant chronic liver disease, such as cirrhosis or active hepatitis (potential participants who test positive for hepatitis B surface antigen or hepatitis C antibodies are allowed provided they do not have active disease requiring antiviral therapy)
•Had a myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
•Has any of the following medical conditions: uncontrolled diabetes, psychiatric disorder (including dementia) that prevents compliance with protocol, uncontrolled seizures, newly diagnosed deep vein thrombosis, active systemic infection that is likely to interfere with study procedure or results
•Has any condition that, in the opinion of the investigator, would compromise the well-being of the participant or the study or prevent the participant from meeting or performing study requirements

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Ovarian Cancer
Open to Enrollment

FORWARD I: A Randomized, Open Label Phase 3 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator's Choice of Chemotherapy in Women With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer

This is a Phase 3, open label, randomized study designed to compare the safety and efficacy of IMGN853 to that of selected single-agent chemotherapy (Investigator's choice) in women with platinum-resistant FR-alpha positive advanced EOC, primary peritoneal...

Investigator:
Nana Tchabo, MD

cancer and/or fallopian tube cancer.

IMGN853-0403 | PHASE II

Sponsor:
ImmunoGen, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Diagnosed with advanced epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer
• Folate receptor alpha positive tumor expression as defined in the protocol
• Patients must have platinum-resistant ovarian cancer, defined as progression within 6 months from completion of a minimum of four cycles of platinum-containing therapy.
• Patients must have received at least one but no more than three prior systemic treatment regimens and for whom single-agent chemotherapy is appropriate as the next line of treatment
• Patients must have at least one lesion that meets the definition of measurable disease by RECIST 1.1

Exclusion Criteria:
• Diagnosis of clear cell or low grade ovarian cancer
• Patients with primary platinum-refractory disease
• Serious concurrent illness or clinically relevant active infection as defined in the protocol
• Prior treatment with IMGN853
• Women who are pregnant or breast feeding

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Ovarian Cancer
Open to Enrollment

Non-Randomized, Open-Label Phase II Study to Assess Olaparib Tablets as a Treatment for Subjects With Different HRD Tumor Status and With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer That Have Received at Least 2 Prior Lines of Chemotherapy

This is a non-randomized, open-label study to assess olaparib tablets as a treatment for subjects with different homologous recombination deficiency (HRD) tumor status and with platinum-sensitive, relapsed, high-grade ovarian cancer. Subjects should have received...

Investigator:
Nana Tchabo, MD

at least 2 prior lines of platinum-based chemotherapy.

D0816L00003 | PHASE II

Sponsor:
AstraZeneca

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 130 Years (Adult, Senior)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Provision of written signed informed consent prior to any study specific procedures;
• Female subjects with histologically diagnosed relapsed high-grade serous ovarian cancer (including primary peritoneal and/or fallopian tube cancer);
• At least 1 lesion (measurable by RECIST v1.1) that can be accurately assessed at baseline by computed tomography (CT)/magnetic resonance imaging (MRI) and is suitable for repeated assessment;
• Subjects must have received at least 2 prior platinum-based lines of chemotherapy for ovarian cancer. Note: There is no limit on the number of non-platinum-based lines of chemotherapy;
• Subjects must be partially-platinum-sensitive (defined as progression 6 to 12 months after the end of the last platinum-based chemotherapy) or platinum sensitive (defined as progression > 12 months after the end of the last platinum-based chemotherapy);
• Subjects must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment;
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 (see Appendix F);
• Subjects must have a life expectancy greater than or equal to 16 weeks;
• Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on Day 1;
• Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations; and
• Formalin fixed, paraffin embedded tumor sample (either archival or fresh sample) from the primary or recurrent cancer must be available for central testing. If there is not written confirmation of the availability of an archived or fresh tumor sample prior to enrollment, the subject is not eligible for the study.

Exclusion Criteria:
• Involvement in the planning and/or conduct of the study (applies to both AstraZeneca Representative staff and/or staff at the study site);
• Previous enrollment in the present study;
• Exposure to any investigational product (IP) within 30 days or 5 half-lives (whichever is longer) prior to start of study treatment;
• Any previous treatment with a PARP inhibitor, including olaparib;
• Subjects who have platinum-resistant or refractory disease defined as progression during or within 6 months of the last platinum-based chemotherapy;
• Other malignancy within the last 5 years (few exceptions apply);
• Resting ECG with clinically significant abnormal findings;
• Subjects receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment;
• Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors;
• Concomitant use of known strong or moderate CYP3A inducers;
• Persistent toxicities (> Common Terminology Criteria for Adverse Event [CTCAE] grade 2) caused by previous cancer therapy, excluding alopecia;
• Subjects with MDS/AML or with features suggestive of MDS/AML;
• Subjects with pneumonitis or at risk of pneumonitis;
• Subjects with symptomatic uncontrolled brain metastases;
• Major surgery within 2 weeks of starting study treatment, and subjects must have recovered from any effects of any major surgery;
• Subjects considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection;
• Breast feeding women;
• Immunocompromised subjects, e.g., subjects who are known to be serologically positive for human immunodeficiency virus;
• Subjects with known active hepatitis (i.e., Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids

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Ovarian Cancer
Open to Enrollment

Phase 1/2 Clinical Study of Niraparib in Combination With Pembrolizumab in Patients With Advanced or Metastatic Triple-Negative Breast Cancer and in Patients With Recurrent Ovarian Cancer

This Phase 1/2 study will evaluate the safety and efficacy of combination treatment with niraparib and pembrolizumab (MK-3475) in patients with advanced or metastatic triple-negative breast cancer or recurrent ovarian cancer. (KEYNOTE-162)

Investigator:
Nana Tchabo, MD
3000-PN162-01-001 | PHASE I/II

Sponsor:
Tesaro Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Main Inclusion Criteria:
• Histologically proven advanced (unresectable) or metastatic cancer as outlined below
a.Patients with triple-negative breast cancer (TNBC) who have been treated with at least 1 prior regimen for advanced/metastatic disease or who relapsed/progressed while on or within 1 month from completion of adjuvant chemotherapy
Phase 1: Up to 3 lines of prior chemotherapy are allowed
Phase 2: Up to 2 lines of prior chemotherapy are allowed
b.Patients with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer who have recurrent disease and have been previously treated with chemotherapy for advanced/metastatic disease and who experienced a response lasting at least 6 months to first-line platinum-based therapy but currently considered platinum-resistant
Phase 1: Up to 4 lines of prior chemotherapy are allowed
Phase 2: Up to 3 lines of prior chemotherapy are allowed
• Archival tumor tissue available or a fresh biopsy must be obtained prior to study treatment initiation
• Measurable lesions by RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) 0 or 1
• Adequate organ function
• Able to take oral medications
• Female patient, if of childbearing potential, has a negative serum pregnancy test within 72 hours of taking study medication and agrees to abstain from activities that could result in pregnancy from enrollment through 120 days after the last dose of study treatment
• Male patient agrees to use an adequate method of contraception

Main Exclusion Criteria:
• Progressed while on platinum treatment or within 1 month from completion of platinum-containing regimen in any line of therapy
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis Note: Patients previously treated for brain metastases may be able to participate provided they are stable
• Patient has a known additional malignancy that progressed or required active treatment within the last 5 years (exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer)
• Poor medical risk
• Pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study
• Immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
• Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
• Known active hepatitis B or hepatitis C
• Active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
• History of interstitial lung disease
• Known history of platelet transfusion for chemotherapy-induced thrombocytopenia or persistent (> 4 weeks) ≥ Grade 3 hematological toxicity or fatigue from prior cancer therapy
• Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2
• Prior treatment with a known poly(ADP-ribose) polymerase (PARP) inhibitor
• Heart-rate corrected QT interval (QTc) prolongation > 470 msec at screening
• Known history of myelodysplastic syndrome (MDS) or a pre-treatment cytogenetic testing result at risk for a diagnosis of MDS/acute myeloid leukemia (AML)
• Receiving concomitant medications that prolong QTc and is unable to discontinue use

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Ovarian Cancer
Open to Enrollment

Use of the CA125 Algorithm for the Early Detection of Ovarian Cancer in Low Risk Women

The goal of this clinical research study is to evaluate a method involving a blood test, called CA-125, that may be helpful in the early detection of ovarian cancer in post-menopausal women.

Investigator:
Daniel Tobias, MD
ID01-022

Sponsor:
University of Texas M.D. Anderson Cancer Center

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 50 Years to 74 Years
Genders Eligible for Study: Female
Accepts Healthy Volunteers: Yes
Sampling Method: Non-Probability Sample

Study Population: Study participants considered to be at low risk for ovarian cancer.

Inclusion Criteria:
1.Female, >/= 50 years old or less than 75 years old
2.Postmenopausal (>/= 12 months amenorrhea)
3.Have at least one ovary
4.Cancer-free and have not received any chemotherapy or radiation therapy for >/=12 months prior to enrolling on this study
a. Women who have a history of non-ovarian malignancy will be eligible if they have no persistent or recurrent disease and have not received treatment for >12 months.
b. If they are on SERM (i.e. tamoxifen or aromatase inhibitors) they will not be excluded.
c. Women maybe undergoing or have had treatment <12 months prior to study entry for basal cell carcinoma only.
5.Willingness to return to an Atlantic Health System medical center for CA 125 blood tests annually or earlier if indicated
6.Willingness to return to an Atlantic Health System medical center to undergo transvaginal ultrasound if indicated.
7.Women need to provide the name of a gynecologist or qualified healthcare professional willing to provide appropriate follow-up care if indicated

Exclusion Criteria:
1.Female: Less than 50 years old or older than 75 years
2.Psychiatric or psychological or other conditions which prevent a fully informed consent.
3.Prior removal of both ovaries.
4.Active non-ovarian malignancy.
5. High risk for ovarian cancer: These conditions can also be met using the participant and one 1st or 2nd degree female relative.
a. Known mutation in BRCA1 or BRCA2
b. Two 1st or 2nd degree relatives of same lineage who have: two ovarian cancers; one ovarian cancer and one pre-menopausal breast cancer; two pre-menopausal breast cancers; one pre-menopausal and one post-menopausal breast cancer.
c. Ashkenazi Jewish descent: one 1st degree or two 2nd degree relatives with pre-menopausal breast or ovarian cancer; or participant has had pre-menopausal breast cancer.
6. 1st or 2nd degree male relative with breast cancer diagnosed at any age.
7. HNPCC/Lynch Syndrome: known genetic mutation, presumed HNPCC carrier, Amsterdam criteria.

First degree relative defined as: children, siblings and parents. Second degree relative defined as: half-siblings, aunts, uncles, nieces, nephews, grandparents, and grandchildren.

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Pancreatic Cancer
Open to Enrollment

Preoperative Extended Chemotherapy vs. Chemotherapy Plus Hypofractionated Radiation Therapy for Borderline Resectable Adenocarcinoma of the Head of the Pancreas

The purpose of this study is to compare any good and bad effects of using chemotherapy compared to chemotherapy and radiation prior to surgery. This study will allow the researchers to know whether which approach is better, the same, or worse than the other.

Investigator:
Angela Alistar, MD

The purpose of this study is to compare any good and bad effects of using chemotherapy compared to chemotherapy and radiation prior to surgery. This study will allow the researchers to know whether which approach is better, the same, or worse than the other.

A021501 | PHASE II

Sponsor:
Alliance

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Pre-Registration Eligibility Criteria:
1.Documentation of Disease:
◦Pathology: Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinate process. Diagnosis should be verified by local pathologist.
◦TNM Stage: TX, T1-4N0-1orNxM0*
◾M1 disease includes spread to distant lymph nodes, organs, and ascites
◦Criteria for borderline resectable disease: Local radiographic reading must be consistent with borderline resectable cancer of the pancreatic head as defined by intergroup radiographic criteria and must meet any one or more of the following on CT/MRI:
◾An interface is present between the primary tumor and the superior mesenteric vein or portal vein and measures ≥ 180° of the circumference of the vessel wall
◾Short-segment occlusion of the SMV-PV is present with normal vein above and below the level of obstruction that is amenable to resection and venous reconstruction
◾Short segment interface (of any degree) is present between tumor and hepatic artery with normal artery proximal and distal to the interface that is amenable to resection and reconstruction
◾An interface is present between the tumor and superior mesenteric artery or celiac axis measuring < 180° of the circumference of the vessel wall
◦Patients with less extensive disease than the above four (4) criteria are considered potentially resectable and are NOT eligible.
◦Patients with more extensive disease than the above 4 criteria are considered locally advanced and are NOT eligible.
◦In addition patients with the following are considered locally advanced and are NOT eligible: Any interface between the tumor and the aorta.
◦See the protocol for additional clarification and definitions of less and more extensive disease.

Registration Eligibility Criteria:
1.Disease Status - Confirmation of radiographic stage as borderline resectable disease by real-time Alliance central radiographic review
2.Prior Treatment
◦No prior chemotherapy or radiation for pancreatic cancer
◦No definitive resection of pancreatic cancer
3.Concomitant Medications
◦Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study. See the protocol for more information.
◦Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment. See the protocol for more information.
4.Medical History
◦No grade ≥ 2 neuropathy
◦No known Gilbert's Syndrome or known homozygosity for UGAT1A1*28 polymorphism
◦No uncontrolled gastric ulcer disease (Grade 3 gastric ulcer disease) within 28 days of registration
5.Pregnancy and Nursing Status - Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 7 days prior to registration is required.
6.Age ≥ 18 years
7.ECOG Performance Status 0 or 1
8.Required Initial Laboratory Values:
◦Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
◦Platelet Count ≥ 100,000/mm3
◦Creatinine ≤ 1.5 x upper limit of normal (ULN) or
◦Calc. Creatinine Clearance > 45 mL/min
◦Total Bilirubin ≤ 2.0 mg/dL
◦AST / ALT ≤ 2.5 x ULN

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Parkinson's Disease
Open to Enrollment

A Multicenter, Randomized, Placebo-controlled, Double-blind, 16 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesias

Amantadine has been used for many years as a treatment for Parkinson's disease. It has been reported in the literature to effectively treat the motor complications of levodopa, especially dyskinesia, but it must be given 2 to 4 times a day. The purpose of...

Investigator:
Marcie Rabin, MD

this multi-center, randomized, double-blind, parallel-group, 16 week study is to compare the efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's disease. The dose will be given once a day in the morning so that amantadine concentrations are maintained throughout the day for treating the levodopa induced dyskinesia, but will be lower during the night, potentially reducing the negative impact of amantadine on sleep.

OS320-3005 | PHASE III

Sponsor:
Osmotica Pharmaceutical Corporation

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 30 Years to 85 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
- Signed IRB/IEC informed consent form.,
- Idiopathic Parkinson's disease per the UK Parkinson's Disease Society Brain Bank criteria.
- Male or female 30 to 85 years old.
- Levodopa induced, predictable peak-effect dyskinesia considered problematic and/or disabling.
- Screening serum creatinine level within normal range
- On stable doses of all oral anti-Parkinson's medication, including any levodopa preparation, for 30 days and be willing to remain on the same doses throughout the trial.
- The subject/caregiver must demonstrate the ability to complete an accurate home diary based on training and evaluation during the screening period.

Exclusion Criteria:
-Secondary parkinsonian syndrome, such as vascular, postinflammatory,drug-induced, neoplastic and post-traumatic parkinsonism or any atypical parkinsonian syndrome (e.g., Progressive Supranuclear Palsy, Multi-System Atrophy, etc.);
- Use of amantadine within 14 days before study start, or previously had an adverse event to amantadine
- Currently taking neuroleptics and atypical antipsychotic agents, acetylcholinesterase inhibitors, apomorphine, rimantadine, memantine and dextromethorphan and quinidine if used in combination for treating dyskinesia.
- History of neurosurgical intervention for treating Parkinson's s disease (i.e. pallidotomy or implanted with a deep brain stimulator).
- Any medical condition or past medical history that would increase the risk of exposure to Amantadine HCl Extended Release Tablets or interfere with safety and efficacy evaluations.
- History of cancer within 5 years of screening with following exceptions: adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer or in situ cervical cancer.
- History or current diagnosis of schizophrenia or bipolar disorder;
- Inadequately treated Major Depressive Disorder. Subjects on stable doses of selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) are eligible for the study.
- Is at imminent risk of suicide or had a suicide attempt within 6 months of screening
- History or current diagnosis of Impulse Control Disorder
- Calculated plasma creatinine clearance of <60 mL/min at screening
- History of or currently has any of the following clinically significant conditions, cardiovascular, respiratory, renal, hepatic, or gastrointestinal disease
- Any clinically significant vital sign, ECG, or laboratory abnormalities:
- A positive test for HIV antibody or history of HIV; hepatitis B surface antigen unless the positive test followed a recent (<28 days) vaccination for hepatitis B; hepatitis C antibody.
- A positive urine drug test.
- Pregnant or breastfeeding at screening or has a positive pregnancy test
- If a sexually active female, is not surgically sterile or at least 2 years post-menopausal, or does not agree to utilize an effective method of contraception from the screening visit to at least 4 weeks after the completion of study treatment.
- History of alcohol or narcotic substance abuse ≤1 year before screening.
- Has dementia or another psychiatric illness that prevents provision of informed consent.
- Has a known hypersensitivity to the study treatment(s), based on known allergies to drugs of the same class including rimantadine HCl and memantine HCl.
- Has participated in other studies involving investigational drugs or surgeries within the last 30 days or investigational biologics within the last 6 months prior to screening.
- Plans to undergo major elective surgery during the course of the study.
- Received administration of Live Attenuated Influenza Vaccine (LAIV) within 2 weeks.
- Cognitive impairment, as evidenced by a score <26 on the Montreal Cognitive Assessment (MoCA) at the screening visit.

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Parkinson's Disease
Open to Enrollment

A Multicenter, Randomized, Placebo-controlled, Double-blind, 26 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesias

Amantadine HCl ER has been used for many years as a treatment for Parkinson's disease. It has been reported in the literature to effectively treat the motor complications of levodopa, especially dyskinesia, but it must be given 2 to 4 times a day. The purpose...

Investigator:
Marcie Rabin, MD

of this multi-center, randomized, double-blind, parallel-group, 26 week study is to compare the efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's disease. The dose will be given once a day in the morning so that amantadine concentrations are maintained throughout the day for treating the levodopa induced dyskinesia, but will be lower during the night, potentially reducing the negative impact of amantadine on sleep.

OS320-3006 | PHASE III

Sponsor:
Osmotica Pharmaceutical Corporation

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 30 Years to 85 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:

- Signed IRB/IEC informed consent form.
- Idiopathic Parkinson's disease per the UK Parkinson's Disease Society Brain Bank criteria.
- Male or female 30 to 85 years old.
- Levodopa induced, predictable peak-effect dyskinesia considered problematic and/or disabling.
- Screening serum creatinine level within normal range
- On stable doses of all oral anti-Parkinson's medication, including any levodopa preparation, for 30 days and be willing to remain on the same doses throughout the trial.
- The subject/caregiver must demonstrate the ability to complete an accurate home diary based on training and evaluation during the screening period.

Exclusion Criteria:
- Secondary parkinsonian syndrome, such as vascular, postinflammatory,drug-induced, neoplastic and post-traumatic parkinsonism or any atypical parkinsonian syndrome (e.g., Progressive Supranuclear Palsy, Multi-System Atrophy, etc.);
- Use of amantadine within 14 days before study start, or previously had an adverse event to amantadine
- Currently taking neuroleptics and atypical antipsychotic agents, acetylcholinesterase inhibitors, apomorphine, rimantadine, memantine and dextromethorphan and quinidine if used in combination for treating dyskinesia.
- History of neurosurgical intervention for treating Parkinson's s disease (i.e. pallidotomy or implanted with a deep brain stimulator)
- Any medical condition or past medical history that would increase the risk of exposure to Amantadine HCl Extended Release Tablets or interfere with safety and efficacy evaluations.
- History of cancer within 5 years of screening with following exceptions: adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer or in situ cervical cancer.
- History or current diagnosis of schizophrenia or bipolar disorder;
- Inadequately treated Major Depressive Disorder. Subjects on stable doses of selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) are eligible for the study;
- Is at imminent risk of suicide or had a suicide attempt within 6 months of screening
- History or current diagnosis of Impulse Control Disorder
- Calculated plasma creatinine clearance of <60 mL/min at screening
- History of or currently has any of the following clinically significant conditions, cardiovascular, respiratory, renal, hepatic, or gastrointestinal disease
- Any clinically significant vital sign, ECG, or laboratory abnormalities;
- A positive test for HIV antibody or history of HIV; hepatitis B surface antigen unless the positive test followed a recent (<28 days) vaccination for hepatitis B; hepatitis C antibody;
- A positive urine drug test.
- Pregnant or breastfeeding at screening or has a positive pregnancy test
- If a sexually active female, is not surgically sterile or at least 2 years post-menopausal, or does not agree to utilize an effective method of contraception from the screening visit to at least 4 weeks after the completion of study treatment.
- History of alcohol or narcotic substance abuse ≤1 year before screening.
- Has dementia or another psychiatric illness that prevents provision of informed consent.
- Has a known hypersensitivity to the study treatment(s), based on known allergies to drugs of the same class including rimantadine HCl and memantine HCl.
- Has participated in other studies involving investigational drugs or surgeries within the last 30 days or investigational biologics within the last 6 months prior to screening.
- Plans to undergo major elective surgery during the course of the study.
- Received administration of Live Attenuated Influenza Vaccine (LAIV) within 2 weeks.
- Cognitive impairment, as evidenced by a score <26 on the Montreal Cognitive Assessment (MoCA) at the screening visit.

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Parkinson's Disease
Open to Enrollment

A Randomized, Double-blind, Placebo-controlled Trial of Urate-elevating Inosine Treatment to Slow Clinical Decline in Early Parkinson's Disease

A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial to determine whether oral inosine dosed to moderately elevate serum urate (from =5.7 mg/dL to 7.1-8.0 mg/dL) over 2 years slows clinical decline in early PD. Clinical decline will be...

Investigator:
Marcie Rabin, MD

assessed as change in the primary outcome variable of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), a composite scale comprising patient- and clinician-reported outcomes.

SURE-PD3 | PHASE III

Sponsor:
National Institute of Health

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 30 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

INCLUSION CRITERIA:

Study subjects meeting all of the following criteria will be allowed to enroll in the study:
1. Willingness and ability to give written informed consent and to comply with trial procedures.
2. Fulfillment of diagnostic criteria for idiopathic PD with at least two of the cardinal signs of PD (resting tremor, bradykinesia, rigidity) present at 2nd screening and baseline evaluations, as assessed by the Site Investigator.
3. Absence of current or imminent (within 90 days of enrollment) PD disability requiring dopaminergic therapy, as assessed by the Site Investigator.
4. Modified Hoehn and Yahr Scale Stage 1 to 2.5 inclusive.
5. Age 30 or older at the time of PD diagnosis.
6. Diagnosis of PD made within 3 years prior to 1st Screening Visit.
7. Non-fasting serum urate ≤ 5.7 mg/dL at 1st Screening Visit (SC1).
8. If the subject is female, then:
a. Being surgically sterile (hysterectomy or tubal ligation), or
b. Being postmenopausal (last menstruation was two years or more prior to 2nd Screening Visit), or
c. For those of childbearing potential
◾ Using a reliable form of contraception for 60 days or more prior to Baseline Visit and agreeing to continue such use for 30 days post last dose of study drug. Reliable forms of contraception include: abstinence; implanted, injected or oral contraceptives (birth control pills), intrauterine device in place for at least 3 months prior to Baseline Visit, vaginal ring with spermicide, barrier with spermicide such as male or female condom, diaphragm or cervical cap, transdermal patch; male partner with vasectomy.
◾ And having a negative pregnancy test at the 2nd Screening Visit. [Note that a urine pregnancy test will be performed at screening on all women who are not at least two years postmenopausal or surgically sterile.]

EXCLUSION CRITERIA:

Study subjects meeting any of the following criteria during screening evaluations will be excluded from entry into the study:
1. Atypical parkinsonism, including that due to drugs, metabolic disorders, encephalitis, cerebrovascular disease, normal pressure hydrocephalus, or other neurodegenerative disease.
2. Dopamine transporter (DAT) brain scan without evidence of dopamine deficit.
3. History of gout.
4. History of uric acid or urate urolithiasis, or recurrent urolithiasis all of unknown type.
5. A screening test positive for uric acid crystalluria, urine pH ≤ 5.0, or an estimated glomerular filtration rate < 60 ml/min/1.73 m2.
6. History of myocardial infarction or stroke.
7. Symptomatic congestive heart failure with a documented ejection fraction below 45%.
8. History of severe chronic obstructive pulmonary disease.
9. Mini Mental State Exam score < 25; i.e., a score of 0 to 24.
10. Use of any anti-parkinsonian medication (including levodopa, dopamine agonists, amantadine, entacapone and the anticholinergic agents trihexyphenidyl and benztropine) other than monoamine oxidase-B inhibitors within 60 days of Baseline, or in excess of 90 days.
11. Change in the dosage of (or initiation of) a monoamine oxidase-B (MAO-B) inhibitor within 90 days prior to Baseline, i.e., entry on a MAO-B inhibitor requires a stable dosage for the 90 days prior to Baseline.
12. Use of the following within 30 days prior to the Baseline Visit: inosine, allopurinol, febuxostat, probenecid, more than 50 IU of vitamin E daily, or more than 300 mg of vitamin C daily (though a daily standard multivitamin such as Bayer One-A-Day® or Centrum® is permissible), reserpine, methylphenidate, amphetamines, cinnarizine, monoamine oxidase-A inhibitors, tetrabenazine, neuroleptics or other dopamine blocking drugs.
13. Use of the following within 90 days prior to the DAT neuroimaging screening evaluation: modafinil, armodafinil, metoclopramide, alpha-methyldopa, methylphenidate, reserpine, or amphetamine derivative.
14. Unstable dosing of a thiazide -- such as hydrochlorothiazide (e.g., Esidrex), chlorothiazide (e.g., Diuril), chlorthalidone (e.g., Hygroton), indapamide (e.g., Lozol), metolazone (e.g., Zaroxolyn), which are permissible as long as the subject is on a stable dose from 1 week prior to the 1st Screening Visit through the Baseline Visit.
15. Known unstable medical or psychiatric condition that may compromise participation in the study. (Note that difficulty swallowing large capsules might preclude participation due to the size of the study drug capsules.)
16. Clinically serious abnormality in the screening visit laboratory studies or ECG, as determined by the Site Investigator.
17. Participation in another investigational treatment study within 30 days prior to the Baseline Visit.
18. Known hypersensitivity or intolerability to inosine.
19. Known hypersensitivity to DaTscan (either the active substance of ioflupane I-123 or to any of the excipients).

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Parkinson's Disease
Open to Enrollment

Phase 3 Multicenter Randomized Double-Blind, Double-dummy, Active-Controlled Study Comparing Efficacy/Safety of Gastric-retentive, Controlled-release Accordion Pill Carbidopa/Levodopa to Immediate Release in Fluctuating Parkinson's Patients

The purpose of this study is to determine whether the gastric retentive Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) is more effective than the commercially available immediate release Carbidopa/Levodopa in reducing motor fluctuations such as "off time" in...

Investigator:
Marcie Rabin, MD