PIONEER-OLE: Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03496168

Collaborator

(none)

Enrollment

Locations

Arm

66.5

Anticipated Duration (Months)

3.3

Patients Per Site

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Hypertrophic Cardiomyopathy	Drug: mavacamten	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Apr 26, 2018

Anticipated Primary Completion Date :

Nov 9, 2023

Anticipated Study Completion Date :

Nov 9, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mavacamten (MYK-461)	Drug: mavacamten mavacamten capsules Other Names: MYK-461

Arm

Intervention/Treatment

Experimental: mavacamten (MYK-461)

Drug: mavacamten

mavacamten capsules

Other Names:

MYK-461

Outcome Measures

Primary Outcome Measures

Frequency and severity of adverse events and serious adverse events. [Up to 260 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution - 0003	Scottsdale	Arizona	United States	85259
2	Local Institution - 0001	New Haven	Connecticut	United States	06520-8017
3	Local Institution - 0004	Durham	North Carolina	United States	27710
4	Local Institution - 0002	Portland	Oregon	United States	97239