This is a rollover study designed to investigate the safety and effectiveness of investigational study drug ARRY-371797 in patients who previously received ARRY-371797 in a study for patients with LMNA-related dilated cardiomyopathy sponsored by Array BioPharma and may, in the Investigator's opinion, derive benefit from continued treatment.
Assess the safety of study drug in terms of adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: 24 months ]
- Assess the efficacy of study drug in terms of change in 6-minute walk test. [ Time Frame: 24 months ]
- Assess the efficacy of study drug in terms of left ventricular function. [ Time Frame: 24 months ]
- Assess the efficacy of study drug in terms of right ventricular function. [ Time Frame: 24 months ]
- Assess the efficacy of the study drug in terms of quality of life. [ Time Frame: 24 months ]
- Characterize the pharmacokinetics (PK) of study drug and metabolites in terms of plasma concentration-time profiles and model-based PK parameters. [ Time Frame: 6 months ]
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
- Received ARRY-371797 as treatment for a genetic dilated cardiomyopathy secondary to LMNA mutations in a clinical study sponsored by Array BioPharma.
- May, in the opinion of the Investigator, benefit from continued ARRY-371797 treatment.
- Additional criteria exist.
Discontinued treatment in the parent study for any reason other than study completion or Sponsor termination of the study.
Additional criteria exist.
United States, Colorado - University of Colorado - Aurora, Colorado, United States, 80045
United States, Maryland - Johns Hopkins University - Baltimore, Maryland, United States, 21205
United States, Massachusetts - Brigham and Women's Hospital - Boston, Massachusetts, United States, 02115
United States, Wisconsin - Meriter Wisconsin Heart - Madison, Wisconsin, United States, 53713