Bomedemstat (IMG-7289/MK-3543) in Participants With Myelofibrosis (IMG-7289-CTP-102/MK-3543-002)

Completed · Phase 1/Phase 2

Conditions studied: Myelofibrosis, Post-polycythemia Vera Myelofibrosis (PPV-MF), Post-essential Thrombocythemia Myelofibrosis (PET-MF), Primary Myelofibrosis (PMF)

In brief

This is a Phase 1/2 open-label study to evaluate the safety, tolerability, steady-state pharmacokinetic (PK) and pharmacodynamics (PD) of a lysine-specific demethylase 1 (LSD1) inhibitor, bomedemstat (IMG-7289/MK-3543), administered orally once daily in participants with myelofibrosis. The primary hypothesis is that bomedemstat is a safe and tolerable orally available agent when administered to participants with myelofibrosis including primary myelofibrosis (PMF), post-polycythaemia vera-myelofibrosis (PPVMF), and post-essential thrombocythaemia-myelofibrosis (PET-MF) (collectively referred to as 'MF'); inhibition of LSD1 by bomedemstat will reduce spleen size in those with splenomegaly, improve haematopoiesis and reduce constitutional symptoms associated with these disorders.

Key facts

Study ID

NCT03136185

Run by

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

People needed

90

Starts

2017-07-18

Expected to finish

2022-03-08

Last updated by the study team

2024-01-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >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

You may not qualify if…

• 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

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Universitatsklinikum Essen — Essen, Germany
• Azienda Ospedaliero Universitaria Careggi — Florence, Italy
• Guy's and St Thomas' Hospitals — London, United Kingdom

Full record on ClinicalTrials.gov

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