Trial Search Results

A 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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Array BioPharma

Stanford Investigator(s):

Intervention(s):

  • Drug: ARRY-371797
  • Other: Placebo

Phase:

Phase 3

Eligibility


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jennifer Kim or Brianna Tucker
650-725-6911
Recruiting