Clinical Trials /

IMG-7289 in Patients With Myelofibrosis

NCT03136185

Description:

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

Related Conditions:
  • Myelofibrosis Transformation in Essential Thrombocythemia
  • Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase
  • Primary Myelofibrosis
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: IMG-7289 in Patients With Myelofibrosis
  • Official Title: A Multi-Center, Open Label Study to Assess the Safety, Steady-State Pharmacokinetics and Pharmacodynamics of IMG-7289 in Patients With Myelofibrosis

Clinical Trial IDs

  • ORG STUDY ID: IMG-7289-CTP-102
  • NCT ID: NCT03136185

Conditions

  • Myelofibrosis
  • Post-polycythemia Vera Myelofibrosis (PPV-MF)
  • Post-essential Thrombocythemia Myelofibrosis (PET-MF)
  • Primary Myelofibrosis (PMF)

Interventions

DrugSynonymsArms
IMG-7289LSD1 inhibitorIMG-7289

Purpose

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

Detailed Description

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

Trial Arms

NameTypeDescriptionInterventions
IMG-7289ExperimentalSingle starting dose with individualized dose titrations throughout
  • IMG-7289

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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.
Safety Issue:
Description:as measured by the frequent monitoring of: adverse events, physical examination and vital signs and laboratory parameters.

Secondary Outcome Measures

Measure:Drug Concentration (performed in Phase 1/2a only)
Time Frame:Up to 3 months.
Safety Issue:
Description:as measured by Cmin sampling.
Measure:Spleen Volume
Time Frame:Baseline to each visit where the variable is measured.
Safety Issue:
Description:Reduction in spleen volume based on MRI (or CT)

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Imago BioSciences,Inc.

Trial Keywords

  • LSD1

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