Myelodysplastic Syndrome Clinical Trial

A Study of Bomedemstat (MK-3543) in Participants With Polycythemia Vera (MK-3543-004)

Summary

This is a Phase 2 open label study of an orally administered LSD1 inhibitor, bomedemstat (IMG-7289), in patients with polycythemia vera.

This study investigates the following:

The safety and tolerability of bomedemstat
The pharmacodynamic effect of bomedemstat

View Full Description

Full Description

This is a Phase 2 multi-center, open-label study evaluating the safety, efficacy, pharmacokinetics and pharmacodynamics of bomedemstat administered orally once daily in participants with PV.

Participants will receive 36 weeks of dosing and may qualify for additional treatment thereafter.

Participants will be followed closely throughout the study for both adverse events by frequent monitoring of clinical signs and symptoms as well as safety labs. Efficacy and pharmacodynamic effects will be closely monitored by frequent hematology assessments of peripheral blood. Throughout dosing, transfusions or phlebotomy may be administered if needed in accordance with standard institutional guidelines.

To ensure safety, a Safety Advisory Board will perform periodic reviews of safety parameters and pharmacodynamic markers.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Has a diagnosis of Polycythemia Vera per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms
Has a bone marrow fibrosis score of Grade 0 or Grade 1
Has failed at least one standard cytoreductive therapy to lower hematocrit
Has a life expectancy >36 weeks
Has discontinued prior cytoreductive therapy for 2 weeks (4 weeks for interferon) prior to study drug initiation

Exclusion Criteria:

Has an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or greater
Has unresolved treatment related toxicities from prior therapies (unless resolved to ≤ Grade 1)
Has an uncontrolled active infection
Has a known human immunodeficiency virus (HIV) infection or active Hepatitis B or Hepatitis C virus infection
Has evidence of increased risk of bleeding, including known bleeding disorders
Is pregnant or lactating

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 2

Estimated Enrollment:

20

Study ID:

NCT05558696

Recruitment Status:

Recruiting

Sponsor:

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

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There are 9 Locations for this study

See Locations Near You

Hematology Oncology of the North Shore ( Site 0104)
Skokie Illinois, 60076, United States More Info
Study Coordinator
Contact
847-675-3900
University of Michigan Comprehensive Cancer Center ( Site 0008)
Ann Arbor Michigan, 48109, United States More Info
Study Coordinator
Contact
734-647-1017
Comprehensive Cancer Centers of Nevada - Peak ( Site 0118)
Las Vegas Nevada, 89128, United States More Info
Study Coordinator
Contact
702-952-2140
Duke University Medical Center ( Site 0016)
Durham North Carolina, 27705, United States More Info
Study Coordinator
Contact
919-684-8111
Monash Medical Centre ( Site 0006)
Clayton Victoria, 3168, Australia More Info
Study Coordinator
Contact
03 9594 4366
United Lincolnshire Hospitals NHS Trust ( Site 0204)
Lincoln Great Britain, LN2 5, United Kingdom More Info
Study Coordinator
Contact
+441205445790
Imperial College London ( Site 0025)
London Great Britain, W12 0, United Kingdom More Info
Study Coordinator
Contact
442033134340
Boston Pilgrim Hospital ( Site 0207)
Boston Lincolnshire, PE21 , United Kingdom More Info
Study Coordinator
Contact
07720373877
Royal Gwent Hospital ( Site 0201)
Newport Wales, NP9 2, United Kingdom More Info
Study Coordinator
Contact
+44 01633238480

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 2

Estimated Enrollment:

20

Study ID:

NCT05558696

Recruitment Status:

Recruiting

Sponsor:


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

How clear is this clinincal trial information?

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