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IMG-7289, With and Without ATRA, in Patients With Advanced Myeloid Malignancies

Sponsor
Imago BioSciences,Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02842827
Collaborator
(none)
45
Enrollment
1
Location
3
Arms
26.3
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 1 open label study of the dose and duration of an orally administered LSD1 inhibitor, IMG-7289, in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Some participants may also receive all-trans retinoic acid (ATRA; also known as tretinoin and Vesanoid®) in combination with IMG-7289. This study investigates the following:

  • The safety and tolerability of IMG-7289, with and without ATRA

  • The pharmacodynamic effect of different IMG-7289 doses and treatment durations, as well as IMG-7289 administered in combination with ATRA

  • The pharmacokinetics of IMG-2789, with and without ATRA

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Non-Randomized
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 With and Without ATRA (Tretinoin) in Patients With Advanced Myeloid Malignancies
Study Start Date :
Oct 1, 2016
Actual Primary Completion Date :
Oct 1, 2018
Actual Study Completion Date :
Dec 12, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Multiple ascending dose

MAD Cohorts using IMG-7289 alone

Drug: IMG-7289
LSD1 inhibitor
Experimental: Combination Therapy

IMG-7289 in combination with all-trans retinoic acid (ATRA)

Drug: IMG-7289
LSD1 inhibitor

Drug: All-trans retinoic acid
Derivative of Vitamin A, differentiating agent.
Other Names:
  • ATRA, tretinoin, Vesanoid®

    		•
    Experimental: Ascending duration

    Treatment duration extension Cohorts using IMG-7289 alone

    Drug: IMG-7289
    LSD1 inhibitor

    Outcome Measures

    Primary Outcome Measures

    1. Safety and tolerability as measured by monitoring of adverse events, changes in physical examinations, vital signs and laboratory parameters [Assessed from time of first dose through 28 days after end of treatment.]

    Secondary Outcome Measures

    1. Pharmacokinetic parameters as measured by acute and steady state sampling [Cohort 1, Cycle 1 (14 days): Day 1 (pre-dose and 1, 2, 3 and 24 hrs post dose), Day 7 (pre-dose and 0.5, 1, 2, 3, 4, 8, 24, 48, 96 and 168 hrs post dose)]

    2. The adequacy of the treatment regimen in producing a pharmacodynamic effect as measured by the IWG/Cheson response criteria [Assessed from time of first dose through approximately 28 initial days of treatment.]]

      Peripheral blood and bone marrow will be collected serially for assessment of response.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18 years

    • Diagnosis of either AML (all subtypes excluding APL-AML) or MDS by World Health Criteria (WHO)

    • High 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

    • Scheduled hematopoietic stem-cell transplant

    • Current use of prohibited medications

    • Clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS leukemia

    • A concurrent second active and non-stable 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Royal Adelaide Hospital Adelaide South Australia Australia

    Sponsors and Collaborators

    • Imago BioSciences,Inc.

    Investigators

    • Principal Investigator: David Ross, Royal Adelaide Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Imago BioSciences,Inc.
    ClinicalTrials.gov Identifier:
    NCT02842827
    Other Study ID Numbers:
    • IMG-7289-CTP-101
    First Posted:
    Jul 25, 2016
    Last Update Posted:
    Jan 25, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Imago BioSciences,Inc.
    LSD1
    Additional relevant MeSH terms:
    Myelodysplastic Syndromes
    Tretinoin

    Study Results

    No Results Posted as of Jan 25, 2022