Myeloproliferative Neoplasms Clinical Trial
Bomedemstat (IMG-7289/MK-3543) in Participants With Myelofibrosis (IMG-7289-CTP-102/MK-3543-002)
Summary
This is a Phase 2b open label study of an orally administered LSD1 inhibitor, IMG-7289, in patients with myelofibrosis.
This study investigates the following:
The safety and tolerability of IMG-7289
The pharmacokinetics of IMG-7289 (performed in Phase 1/2a only)
The pharmacodynamic effect of IMG-7289
Full Description
This study initiated as a Phase 1/2a study assessing the safety of the starting dose, an 85-day duration of treatment, and the PK and PD effects of bomedemstat, with transition to a Phase 2b study incorporating changes supported by the Phase 1/2a data.
Eligibility Criteria
Inclusion Criteria:
>18 years of age
Diagnosis of either PMF per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms, or PPV-MF or PET-MF per the International Working Group for Myelofibrosis Research and Treatment
High or intermediate-2 risk disease
Exclusion Criteria:
Receiving other treatments for the condition (with exceptions and time limits)
Major surgery in last 4 weeks, any surgery in the last 2 weeks
History of, or scheduled, hematopoietic stem cell transplant within 24 weeks of Screening
History of splenectomy
Current use of prohibited medications
A concurrent second active and nonstable malignancy
Known human immunodeficiency virus infection or active Hepatitis B or Hepatitis C virus infection
Other hematologic/biochemistry requirements, as per protocol
Use of an investigational agent within last 14 days
Pregnant or lactating females
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There are 2 Locations for this study
Ann Arbor Michigan, 48105, United States
Adelaide South Australia, , Australia
Essen , 45147, Germany
Florence , , Italy
London , , United Kingdom
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