Status:
COMPLETED
An Extension Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Myeloproliferative Neoplasms (IMG-7289-CTP-202/MK-3543-005)
Lead Sponsor:
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
Conditions:
Thrombocythemia, Essential
Primary Myelofibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a multi-center, open-label extension study to assess the long-term safety and efficacy of bomedemstat administered orally once daily in participants with a Myeloproliferative Neoplasm (MPN) wh...
Eligibility Criteria
Inclusion
- Inclusion Criteria include, but are not limited to:
- Has completed at least one Treatment Period (TP) in a prior bomedemstat Myeloproliferative Neoplasms (MPN) protocol (such as, but not limited to, IMG-7289-CTP-102/MK-3543-002 (NCT03136185) and IMG-7289-CTP-201/MK-3543-003) (NCT04254978).
- In the estimation of the Investigator, the risk-benefit favors continued dosing with bomedemstat.
Exclusion
- Exclusion Criteria include, but are not limited to:
- Ongoing participation in another investigational study (except observational studies).
- A history of non-compliance in a prior bomedemstat study (excluding dose suspensions that were medically warranted).
- Current use of a prohibited medication (e.g., romiplostim).
- Medical, psychiatric, cognitive, or other conditions that, in the Investigator's opinion, compromise the patient's safety, ability to give informed consent, or comply with the trial protocol.
- Is pregnant or breastfeeding or plan to become pregnant or breastfeed during the study.
- Women of childbearing potential (WOCBP) and fertile men unwilling to agree to use an approved method of contraception from time of enrollment until 14 days after last bomedemstat dose.
Key Trial Info
Start Date :
December 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2024
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT05223920
Start Date
December 15 2021
End Date
August 22 2024
Last Update
September 22 2025
Active Locations (19)
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1
University of Miami Leonard M. Miller
Miami, Florida, United States, 33136
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
3
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
4
UMPC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232