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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

About this trial

This is an interventional treatment trial for Hypertrophic Cardiomyopathy focused on measuring Symptomatic, Obstructive, Left ventricular outflow tract gradient

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT03496168

First Posted

April 5, 2018

Last Updated

June 10, 2022

Sponsor

Bristol-Myers Squibb

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

Data Monitoring Committee

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

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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