Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER (PIONEER-OLE)
Primary Purpose
Hypertrophic Cardiomyopathy
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
mavacamten
Sponsored by
About this trial
This is an interventional treatment trial for Hypertrophic Cardiomyopathy focused on measuring Symptomatic, Obstructive, Left ventricular outflow tract gradient
Eligibility Criteria
Key Inclusion Criteria:
- Completed Study MYK-461-004. Prior participation in a non-interventional observational study is allowed.
- Body weight > 45 kg at Screening
- Has safety laboratory parameters (chemistry and hematology) within normal limits
Key Exclusion Criteria:
- Has QTcF > > 500 ms or any other ECG abnormality considered by the investigator to pose a risk to subject safety (eg, second degree atrioventricular block type II)
- Since enrollment into Study MYK-461-004, has developed obstructive coronary artery disease (> 70% stenosis in one or more arteries) or known moderate or severe aortic valve stenosis
- Since enrollment into Study MYK-461-004, has developed any acute or serious comorbid condition (eg, major infection or hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction) that, in the opinion of the investigator or medical monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
- Since enrollment into Study MYK-461-004 has developed clinically significant malignant disease
Sites / Locations
- Local Institution - 0003
- Local Institution - 0001
- Local Institution - 0004
- Local Institution - 0002
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
mavacamten (MYK-461)
Arm Description
Outcomes
Primary Outcome Measures
Frequency and severity of adverse events and serious adverse events.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03496168
Brief Title
Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER
Acronym
PIONEER-OLE
Official Title
An Open-Label Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in Study MYK-461-004 (PIONEER)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 26, 2018 (Actual)
Primary Completion Date
November 9, 2023 (Anticipated)
Study Completion Date
November 9, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a multicenter open-label study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM) who previously participated in study MYK-461-004 (PIONEER-HCM).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Cardiomyopathy
Keywords
Symptomatic, Obstructive, Left ventricular outflow tract gradient
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mavacamten (MYK-461)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
mavacamten
Other Intervention Name(s)
MYK-461
Intervention Description
mavacamten capsules
Primary Outcome Measure Information:
Title
Frequency and severity of adverse events and serious adverse events.
Time Frame
Up to 260 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Completed Study MYK-461-004. Prior participation in a non-interventional observational study is allowed.
Body weight > 45 kg at Screening
Has safety laboratory parameters (chemistry and hematology) within normal limits
Key Exclusion Criteria:
Has QTcF > > 500 ms or any other ECG abnormality considered by the investigator to pose a risk to subject safety (eg, second degree atrioventricular block type II)
Since enrollment into Study MYK-461-004, has developed obstructive coronary artery disease (> 70% stenosis in one or more arteries) or known moderate or severe aortic valve stenosis
Since enrollment into Study MYK-461-004, has developed any acute or serious comorbid condition (eg, major infection or hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction) that, in the opinion of the investigator or medical monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
Since enrollment into Study MYK-461-004 has developed clinically significant malignant disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0003
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Local Institution - 0001
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8017
Country
United States
Facility Name
Local Institution - 0004
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Local Institution - 0002
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER
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