An Extension Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Myeloproliferative Neoplasms (IMG-7289-CTP-202/MK-3543-005)
NCT ID: NCT05223920
Last Updated: 2025-09-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
81 participants
INTERVENTIONAL
2021-12-15
2024-08-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bomedemstat
All participants will receive bomedemstat via oral capsule daily for 169 days with additional treatment continuing in patients deriving clinical benefit.
Bomedemstat
Capsule (oral)
Interventions
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Bomedemstat
Capsule (oral)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* In the estimation of the Investigator, the risk-benefit favors continued dosing with bomedemstat.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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University of Miami Leonard M. Miller
Miami, Florida, United States
University of Michigan
Ann Arbor, Michigan, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
UMPC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
Gold Coast Hospital and Health Service
Southport, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Universittsklinikum Essen
Essen, , Germany
Queen Mary Hospital
Hong Kong, , Hong Kong
Ospedale di Circolo-a Fondazione Macchi
Varese, VA, Italy
Azienda Ospedaliera SS. Antonio
Alessandria, , Italy
Azienda Ospedaliero-Universitaria Careggi - S.O.D. Ematologia (CRIMM)
Florence, , Italy
Azienda Ospedaliero Universitaria di Bologna
Pavia, , Italy
Middlemore Clinical Trials
Papatoetoe, Aukland, New Zealand
Waitemata District Health Board
Takapuna, Aukland, New Zealand
University College London Hospitals NHS Foundation Trust
London, , United Kingdom
Guy's and Saint Thomas' NHS Foundation Trus
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-3543-005
Identifier Type: OTHER
Identifier Source: secondary_id
IMG-7289
Identifier Type: OTHER
Identifier Source: secondary_id
2021-002452-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IMG-7289-CTP-202
Identifier Type: -
Identifier Source: org_study_id
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