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

NCT02351856

Last updated date
Study Location
University of Colorado
Aurora, Colorado, 80045, United States
Contact
1-800-718-1021

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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
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.

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LMNA-Related Dilated CardiomyopathyA Rollover Study of ARRY-371797 in Patients With LMNA-Related Dilated Cardiomyopathy
NCT02351856
  1. Aurora, Colorado
  2. Baltimore, Maryland
  3. Boston, Massachusetts
  4. Madison, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 22, 2018)
8
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2015)
12
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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: Pfizer )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP