A Rollover Study of ARRY-371797 in Patients With LMNA-Related Dilated Cardiomyopathy
NCT02351856
Last updated date
ABOUT THIS STUDY
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.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
LMNA-Related Dilated Cardiomyopathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Discontinued treatment in the parent study for any reason other than study completion
or Sponsor termination of the study.
- Additional criteria exist.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
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LMNA-Related Dilated CardiomyopathyA Rollover Study of ARRY-371797 in Patients With LMNA-Related Dilated Cardiomyopathy
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Advanced Information
| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | A Rollover Study of ARRY-371797 in Patients With LMNA-Related Dilated Cardiomyopathy | ||||||
| Official Title ICMJE | An Open-label Rollover Study of ARRY-371797 in Patients With Symptomatic Genetic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation | ||||||
| Brief 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. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 2 | ||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
| Condition ICMJE | LMNA-Related Dilated Cardiomyopathy | ||||||
| Intervention ICMJE | Drug: ARRY-371797, p38 inhibitor, oral
multiple dose, single schedule | ||||||
| Study Arms ICMJE | Experimental: ARRY-371797
Intervention: Drug: ARRY-371797, p38 inhibitor, oral | ||||||
| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE | 8 | ||||||
| Original Estimated Enrollment ICMJE | 12 | ||||||
| Actual Study Completion Date ICMJE | December 21, 2020 | ||||||
| Actual Primary Completion Date | September 15, 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
| ||||||
| Sex/Gender ICMJE |
| ||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT02351856 | ||||||
| Other Study ID Numbers ICMJE | ARRAY-797-001 C4411001 ( Other Identifier: Alias Study Number ) | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement ICMJE |
| ||||||
| Responsible Party | Pfizer | ||||||
| Study Sponsor ICMJE | Pfizer | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
| ||||||
| PRS Account | Pfizer | ||||||
| Verification Date | February 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||