Myeloproliferative Neoplasms Clinical Trial
Study of Bomedemstat in Participants With Essential Thrombocythemia (IMG-7289-CTP-201/MK-3543-003)
Summary
This is a Phase 2b open label study of an orally administered LSD1 inhibitor, IMG-7289, in patients with essential thrombocythemia.
This study investigates the following:
The safety and tolerability of IMG-7289
The pharmacodynamic effect of IMG-7289
Full Description
This is a Phase 2 multi-center, open-label study evaluating the safety, efficacy and pharmacodynamics of Bomedemstat administered orally once daily in patients with essential thrombocythemia (ET). Patients will be dosed with Bomedemstat for 169 consecutive days in the Initial Treatment Period (ITP). Qualifying patients may continue to receive Bomedemstat in the Additional Treatment Period (ATP).
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.
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Essential Thrombocythemia per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms.
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:
Has undergone major surgery ≤4 weeks prior to starting study drug or has not recovered from side effects of such surgery.
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
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There are 15 Locations for this study
Jacksonville Florida, 32209, United States
Ann Arbor Michigan, 48109, United States
New York New York, 10021, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44195, United States
Pittsburgh Pennsylvania, 15232, United States
Seattle Washington, 98109, United States
Herston Brisbane, , Australia
Camperdown New South Wales, , Australia
St Leonards New South Wales, 2065, Australia
Southport Queensland, , Australia
Adelaide South Australia, 5000, Australia
Clayton Victoria, 3168, Australia
Essen , 45147, Germany
Jena , , Germany
Hong Kong , , Hong Kong
Alessandria , , Italy
Bologna , , Italy
Florence , 50139, Italy
Varese , , Italy
Auckland , , New Zealand
Auckland , , New Zealand
London , NW1, United Kingdom
London , SE1 9, United Kingdom
London , W12, United Kingdom
Oxford , , United Kingdom
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