CompletedPhase 2

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

United States8 participantsStarted 2015-02-02

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: Baseline up to 30 days after last dose of study drug (i.e., maximum up to 282 weeks)

Number of Participants With Change From Baseline Value in Clinical Laboratory Hematology Test Results to Worst Value

Timeframe: Baseline, Post-Baseline (anytime from first dose of study drug to maximum duration of up to 282 weeks)

Number of Participants With Change From Baseline Value in Clinical Laboratory Chemistry Test Results to Worst Value

Timeframe: Baseline, Post-Baseline (anytime from first dose of study drug to maximum duration of up to 282 weeks)

Number of Participants With Abnormal Physical Examination Findings

Timeframe: Baseline up to 30 days after last dose of study drug (i.e., maximum up to 282 weeks)

Number of Participants With Abnormalities in Vital Signs

Timeframe: Baseline up to 30 days after last dose of study drug (i.e., maximum up to 282 weeks)

Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings

Timeframe: Baseline up to 30 days after last dose of study drug (i.e., maximum up to 282 weeks)

Trial details

NCT IDNCT02351856

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-12-21

Results submitted2021-12-13

View on ClinicalTrials.gov More LMNA-Related Dilated Cardiomyopathy trials