Myeloproliferative Neoplasms Clinical Trial

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

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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

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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.

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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

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

90

Study ID:

NCT03136185

Recruitment Status:

Completed

Sponsor:

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

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There are 2 Locations for this study

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University of Michigan
Ann Arbor Michigan, 48105, United States
Royal Adelaide Hospital
Adelaide South Australia, , Australia
Universitatsklinikum Essen
Essen , 45147, Germany
Azienda Ospedaliero Universitaria Careggi
Florence , , Italy
Guy's and St Thomas' Hospitals
London , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

90

Study ID:

NCT03136185

Recruitment Status:

Completed

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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