A Rollover Study of ARRY-371797 in Patients With LMNA-Related Dilated Cardiomyopathy

Title: 
A Rollover Study of ARRY-371797 in Patients With LMNA-Related Dilated Cardiomyopathy
Recruitment Status: 
Status Last Updated: 
February 28, 2019
Clinical Phenotype(s): 
Gene(s): 
Study Purpose: 

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.

Intervention/Treatment: 
Drug: ARRY-371797, p38 inhibitor, oral
Phase: 
Study Description: 

None

Study Type: 
Official Title: 
A Rollover Study of ARRY-371797 in Patients With LMNA-Related Dilated Cardiomyopathy
Study Start Date: 
February 2015
Study Completion Date: 
February 2022
Primary Objective(s): 

Assess the safety of study drug in terms of adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: 24 months ]

Secondary Objective(s): 
  • 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 ]
Eligibility: 

Ages Eligible for Study: 18 Years and older   (Adult, Older Adult)

Sexes Eligible for Study: All

Accepts Healthy Volunteers: No

Inclusion Criteria: 
  • 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.
Exclusion Criteria: 

Discontinued treatment in the parent study for any reason other than study completion or Sponsor termination of the study.

Additional criteria exist.

Study Site(s)/Location(s): 

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

Sponsors & Collaborators: 

Array BioPharma

Principal Investigator(s): 

None

For more information, please contact the Study Coordinator: 

Contact:  

Email: 

Phone:

ClinicalTrials.gov ID: 
NCT02351856