IMG-7289 in Patients With Myelofibrosis

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

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

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

Intervention / Treatment
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* Drug: IMG-7289


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMG-7289<br>Single starting dose with individualized dose titrations throughout | Drug: IMG-7289<br>* Differentiation therapy<br>* Other names: LSD1 inhibitor;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LSD1