A Study of ARRY-371797 in Patients With Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation



Status:Recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/6/2019
Start Date:March 12, 2018
End Date:July 2020
Contact:Array BioPharma, Inc
Email:clinicaltrials@arraybiopharma.com
Phone:303-381-6604

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A Phase 3, Multinational, Randomized, Placebo-Controlled Study of ARRY-371797 in Patients With Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation

This is a randomized, double-blind, placebo-controlled study in patients with dilated
cardiomyopathy (DCM) due to a gene encoding the lamin A/C protein (LMNA) mutation. The study
will further evaluate a dose level of ARRY-371797 that has shown preliminary efficacy and
safety in this patient population. After the primary analysis has been performed, eligible
patients may receive open-label treatment with ARRY-371797.


Selected Key Inclusion Criteria:

- Patients with symptomatic lamin A/C protein (LMNA)-related cardiomyopathy Class
II/III/ or Class IV defined as:

- Gene positive for a deleterious mutation in the LMNA gene as determined by the
study central laboratory or by initial laboratory testing (central confirmation
of initial laboratory results is required prior to randomization and study
treatment).

- Evidence of cardiac impairment in EF

- Patient will have an implantable cardioverter defibrillator/cardiac resynchronization
therapy defibrillator (ICD/CRT-D). ICD implanted at least 4 weeks prior to initiation
of study treatment or CRT-D initiated at least 6 months prior to initiation of study
treatment

- Class II/III patients must have objective functional impairment evidenced by a
reduction in 6-minute walk test (6MWT);

- Stable medical and/or device therapy consistent with American Heart Association (AHA)
/ American College of Cardiology (ACC) or European Society of Cardiology (ESC)
guidelines

- Patients must meet acceptable hematology, hepatic and renal laboratory values as
specified

Selected Key Exclusion Criteria:

- Presence of other form(s) of cardiomyopathy contributing to HF (e.g., inflammatory or
infiltrative cardiomyopathy) or clinically significant cardiac anatomic abnormality
(e.g., LV aneurysm).

- Clinically significant coronary artery disease (e.g., coronary revascularization,
exercise-induced angina) per Investigator judgment.

- Uncorrected, hemodynamically significant (i.e., moderate-severe) primary structural
valvular disease not due to HF.

- Currently receiving or deemed at high risk of requiring chronic renal replacement
therapy (e.g., hemodialysis or peritoneal dialysis) within 6 months.

- Treatment with any investigational agent(s) for HF within 28 days prior to Day 1. Any
treatment with an investigational agent(s) requires approval from the Medical Monitor.

- Malignancy that is active or has been diagnosed within 3 years prior to screening,
except surgically curatively resected in situ malignancies or surgically cured early
breast cancer, prostate cancer, skin cancer (basal cell carcinoma, squamous cell
carcinoma) or cervical cancer.

- Non-cardiac condition that limits lifespan to < 1 year.

- Serum positive for hepatitis B surface antigen, viremic hepatitis C, or human
immunodeficiency virus (HIV) at screening.
We found this trial at
25
sites
Newark, New Jersey 07103
Principal Investigator: Marc Klapholz, MD
Phone: 973-972-6794
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Neal Lakdawala, MD
Phone: 617-732-6237
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Wai Hong Wilson Tang, MD
Phone: 216-445-1647
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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291 Campus Dr
Stanford, California 94305
(650) 725-3900
Principal Investigator: Matthew Wheeler, MD
Phone: 650-725-6911
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Principal Investigator: Thomas McDonald, MD
Phone: 813-259-0671
University of South Florida The University of South Florida is a high-impact, global research university...
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Aurora, Colorado 80045
Principal Investigator: Matthew Taylor, MD
Phone: 720-848-7090
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300 East Jefferson Street
Boise, Idaho 83712
Principal Investigator: David Hinchman, MD
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Dan Judge, MD
Phone: 843-792-1238
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Clearwater, Florida 33756
Principal Investigator: Miguel Trevino, MD
Phone: 727-584-6368
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Columbus, Georgia 31904
Principal Investigator: Alonzo Jones, MD
Phone: 706-410-1116
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Ray Hershberger, MD
Phone: 614-292-4084
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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3505 Gaston Avenue
Dallas, Texas 75246
Principal Investigator: Robert Gottlieb, MD
Phone: 214-865-2419
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Germantown, Tennessee 38138
Principal Investigator: Frank McGrew, MD
Phone: 901-271-1000
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Gilbert, Arizona 85297
Principal Investigator: Nabil Dib, MD
Phone: 480-728-8736
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Houston, Texas 77225
Principal Investigator: Emerson Perin, MD
Phone: 832-355-9614
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Los Angeles, California 90095
Principal Investigator: Jessica Wang, MD
Phone: 310-291-6606
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Madison, Wisconsin 53715
Principal Investigator: John Moses, MD
Phone: 608-417-2168
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Midland, Michigan 48670
Principal Investigator: Jeffrey Martindale, MD
Phone: 989-631-2469
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Mobile, Alabama 36608
Principal Investigator: John LeDoux, MD
Phone: 251-725-1014
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462 1st Avenue
New York, New York 10010
Principal Investigator: Stephen Pan, MD
Phone: 212-263-4113
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Farhana Latif, MD
Phone: 212-305-1368
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Anjali Owens, MD
Phone: 215-615-0497
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Saint Louis, Missouri 63110
Principal Investigator: Gregory Ewald, MD
Phone: 314-747-2246
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Tucson, Arizona 85724
Principal Investigator: Nancy Sweitzer, MD
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Tullahoma, Tennessee 37388
Principal Investigator: Dinesh Gupta, MD
Phone: 931-461-2663
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