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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-02

Study Completion Date

2020-12-21

Brief Summary

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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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Detailed Description

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Conditions

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LMNA-Related Dilated Cardiomyopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ARRY-371797

Group Type EXPERIMENTAL

ARRY-371797, p38 inhibitor, oral

Intervention Type DRUG

multiple dose, single schedule

Interventions

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ARRY-371797, p38 inhibitor, oral

multiple dose, single schedule

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No