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.
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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
Array BioPharma
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