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IMG-7289 in Patients With Myelofibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03136185
Recruitment Status : Completed
First Posted : May 2, 2017
Last Update Posted : March 29, 2022
Information provided by (Responsible Party):
Imago BioSciences,Inc.

Brief 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

Condition or disease Intervention/treatment Phase
Myelofibrosis Post-polycythemia Vera Myelofibrosis (PPV-MF) Post-essential Thrombocythemia Myelofibrosis (PET-MF) Primary Myelofibrosis (PMF) Drug: IMG-7289 Phase 2

Detailed Description:
With enrollment complete in Phase 1/2a, expansion into Phase 2b has occurred. New patients will be enrolled into Phase 2b study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Open Label Study to Assess the Safety, Steady-State Pharmacokinetics and Pharmacodynamics of IMG-7289 in Patients With Myelofibrosis
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : March 8, 2022
Actual Study Completion Date : March 8, 2022

Arm Intervention/treatment
Experimental: IMG-7289
Single starting dose with individualized dose titrations throughout
Drug: IMG-7289
Differentiation therapy
Other Name: LSD1 inhibitor

Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events, and changes in physical examination, vital signs and laboratory parameters [safety and tolerability] [ Time Frame: Assessed from the time of first dose through 28 days after end of treatment. ]
    as measured by the frequent monitoring of: adverse events, physical examination and vital signs and laboratory parameters.

Secondary Outcome Measures :
  1. Drug Concentration (performed in Phase 1/2a only) [ Time Frame: Up to 3 months. ]
    as measured by Cmin sampling.

  2. Spleen Volume [ Time Frame: Baseline to each visit where the variable is measured. ]
    Reduction in spleen volume based on MRI (or CT)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • >18 years
  • Diagnosis of either PMF per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms, PPV-MF or PET-MF per the IWG-MRT
  • High or intermediate-2 risk disease, as defined per protocol

Exclusion Criteria:

  • Receiving other treatments for the condition (with exceptions and time limits)
  • Major surgery in last 4 weeks, minor 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136185

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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48105
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Universitatsklinikum Essen
Essen, Germany, 45147
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
United Kingdom
Guy's and St Thomas' Hospitals
London, United Kingdom
Sponsors and Collaborators
Imago BioSciences,Inc.
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Principal Investigator: Kristen Pettit University of Michigan
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Responsible Party: Imago BioSciences,Inc.
ClinicalTrials.gov Identifier: NCT03136185    
Other Study ID Numbers: IMG-7289-CTP-102
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: March 29, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imago BioSciences,Inc.:
Additional relevant MeSH terms:
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Polycythemia Vera
Primary Myelofibrosis
Thrombocythemia, Essential
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Bone Marrow Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Blood Platelet Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders