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

Pfizer

Status and phase: Completed; Phase 2

Conditions: LMNA-Related Dilated Cardiomyopathy

Treatments: Drug: ARRY-371797, p38 inhibitor, oral

Study type: Interventional

Funder types: Industry

Identifiers

NCT02351856

ARRAY-797-001

C4411001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key Exclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

ARRY-371797

Experimental group

Treatment:

Drug: ARRY-371797, p38 inhibitor, oral