Study of Bomedemstat in Participants With Essential Thrombocythemia (IMG-7289-CTP-201/MK-3543-003)
NCT ID: NCT04254978
Last Updated: 2024-04-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
73 participants
INTERVENTIONAL
2020-09-08
2023-03-23
Brief Summary
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This study investigates the following:
* The safety and tolerability of Bomedemstat
* The pharmacodynamic effect of Bomedemstat
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Detailed Description
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Safety will be evaluated by clinical assessments of safety parameters i.e., safety laboratory testing, adverse event reporting, physical examination and vital sign assessments. Pharmacodynamics will be evaluated by hematology assessment, patient reported symptom burden, change in spleen size by palpation and other measures.
To ensure safety, a Safety Advisory Board will perform periodic reviews of safety parameters and pharmacodynamic markers.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bomedemstat
Bomedemstat administered daily for 169 consecutive days
Bomedemstat
Oral administration
Interventions
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Bomedemstat
Oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Requires treatment in order to lower platelet count based on patient age over 60 or history of thrombosis.
* Have failed at least one standard therapy
* Must have discontinued ET therapy at least 1 week (4 weeks for interferon) prior to study drug initiation.
Exclusion Criteria
* Unresolved treatment related toxicities from prior therapies (unless resolved to ≤ Grade 1).
* Uncontrolled active infection.
* Current use of prohibited medications
* Known HIV infection or active Hepatitis B or Hepatitis C virus infection
* Other hematologic/biochemistry requirements, as per protocol
* Use of investigational agent within last 14 days
* Pregnant or lactating females
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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Local Institution
Jacksonville, Florida, United States
Local Institution
Ann Arbor, Michigan, United States
Local Institution
New York, New York, United States
Local Institution
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Local Institution
Pittsburgh, Pennsylvania, United States
Local Institution
Seattle, Washington, United States
Local Institution
Herston, Brisbane, Australia
Local Institution
Camperdown, New South Wales, Australia
Local Institution
St Leonards, New South Wales, Australia
Local Institution
Southport, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Local Institution
Clayton, Victoria, Australia
Department of Hematology and Stem Cell Transplantation, West German Cancer Center (WTZ)
Essen, , Germany
Local Institution
Jena, , Germany
Local Institution
Hong Kong, , Hong Kong
Local Institution
Alessandria, , Italy
Local Institution
Bologna, , Italy
CRIMM; Centro Ricerca e Innovazione delle Malattia Mieloproliferative, Azienda ospedaliera Universitaria Careggi
Florence, , Italy
Local Institution
Varese, , Italy
Local Institution
Auckland, , New Zealand
Middlemore Hospital
Auckland, , New Zealand
Local Institution
London, , United Kingdom
Guys and St Thomas Hospital
London, , United Kingdom
Local Institution
London, , United Kingdom
Local Institution
Oxford, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-3543-003
Identifier Type: OTHER
Identifier Source: secondary_id
2019-003659-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IMG-7289-CTP-201
Identifier Type: -
Identifier Source: org_study_id
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