Clinical Trial: NCT03136185 - My Cancer Genome

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:

Active, not recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT03136185

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

Drug	Synonyms	Arms
IMG-7289	LSD1 inhibitor	IMG-7289

Purpose

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

Name	Type	Description	Interventions
IMG-7289	Experimental	Single 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:	Active, not recruiting
Lead Sponsor:	Imago BioSciences,Inc.

Trial Keywords

LSD1

Last Updated

June 29, 2021

Clinical Trials /

IMG-7289 in Patients With Myelofibrosis