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

View Full Description

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.

View Eligibility Criteria

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

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT04254978

Recruitment Status:

Completed

Sponsor:

Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)

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There are 15 Locations for this study

See Locations Near You

Local Institution
Jacksonville Florida, 32209, United States
Local Institution
Ann Arbor Michigan, 48109, United States
Local Institution
New York New York, 10021, United States
Local Institution
Durham North Carolina, 27710, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Local Institution
Pittsburgh Pennsylvania, 15232, United States
Local Institution
Seattle Washington, 98109, United States
Local Institution
Herston Brisbane, , Australia
Local Institution
Camperdown New South Wales, , Australia
Local Institution
St Leonards New South Wales, 2065, Australia
Local Institution
Southport Queensland, , Australia
Royal Adelaide Hospital
Adelaide South Australia, 5000, Australia
Local Institution
Clayton Victoria, 3168, Australia
Department of Hematology and Stem Cell Transplantation, West German Cancer Center (WTZ)
Essen , 45147, 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 , 50139, Italy
Local Institution
Varese , , Italy
Local Institution
Auckland , , New Zealand
Middlemore Hospital
Auckland , , New Zealand
Local Institution
London , NW1, United Kingdom
Guys and St Thomas Hospital
London , SE1 9, United Kingdom
Local Institution
London , W12, United Kingdom
Local Institution
Oxford , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT04254978

Recruitment Status:

Completed

Sponsor:


Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)

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