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IMG-7289 in Patients With Essential Thrombocythemia

Sponsor
Imago BioSciences,Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04254978
Collaborator
(none)
70
Enrollment
26
Locations
1
Arm
31.3
Anticipated Duration (Months)
2.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 2b open label study of an orally administered LSD1 inhibitor, IMG-7289, in patients with essential thrombocythemia.

This study investigates the following:

  • The safety and tolerability of IMG-7289

  • The pharmacodynamic effect of IMG-7289

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This is a Phase 2 multi-center, open-label study evaluating the safety, efficacy and pharmacodynamics of IMG-7289 administered orally once daily in patients with essential thrombocythemia (ET). Patients will be dosed with IMG-7289 for 169 consecutive days in the Initial Treatment Period (ITP). Qualifying patients may continue to receive IMG-7289 in the Additional Treatment Period (ATP).

Safety will be evaluated by clinical assessments of safety parameters i.e. safety laboratory testing, adverse event reporting, physical examination and vital sign assessments. Pharmacodynamics will be evaluated by hematology assessment, patient reported symptom burden, change in spleen size by palpation and other measures.

To ensure safety, a Safety Advisory Board will perform periodic reviews of safety parameters and pharmacodynamic markers.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Multi-center, open-labelMulti-center, open-label
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Multi-Center, Open Label Study to Assess the Safety, Efficacy and Pharmacodynamics of IMG-7289 in Patients With Essential Thrombocythemia
Actual Study Start Date :
Sep 20, 2020
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: IMG-7289

IMG-7289 administered daily for 169 consecutive days

Drug: IMG-7289
LSD1 inhibitor
Other Names:
  • bomedemstat

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The safety of IMG-7289 when administered to patients with essential thrombocythemia [Assessed from the time of first dose through 14 days after end of treatment.]

      Safety measured by incidence and severity of treatment-emergent adverse events (using CTCAE), and changes in physical examination including vital signs, and hematology, coagulation, chemistry and urinalysis laboratory parameters.

    2. The efficacy of IMG-7289 when administered to patients with essential thrombocythemia [Assessed serially at each visit from time of first dose through 14 days after end of treatment]

      Change in platelet counts to the protocol defined target threshold, in the absence of new thromboembolic events

    Eligibility Criteria

    Criteria

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

    • Diagnosis of Essential Thrombocythemia per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms.

    • Requires treatment in order to lower platelet count based on patient age over 60 or history of thrombosis.

    • Have failed at least one standard therapy

    • Must have discontinued ET therapy at least 1 week (4 weeks for interferon) prior to study drug initiation.

    Exclusion Criteria:

    • Has undergone major surgery ≤4 weeks prior to starting study drug or has not recovered from side effects of such surgery.

    • Unresolved treatment related toxicities from prior therapies (unless resolved to ≤ Grade 1).

    • Uncontrolled active infection.

    • Current use of prohibited medications

    • 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 Local Institution Jacksonville Florida United States 32209
    2 Local Institution Ann Arbor Michigan United States 48109
    3 Local Institution New York New York United States 10021
    4 Local Institution Durham North Carolina United States 27710
    5 Cleveland Clinic Cleveland Ohio United States 44195
    6 Local Institution Pittsburgh Pennsylvania United States 15232
    7 Local Institution Seattle Washington United States 98109
    8 Local Institution Herston Brisbane Australia
    9 Local Institution Camperdown New South Wales Australia
    10 Local Institution St Leonards New South Wales Australia 2065
    11 Local Institution Southport Queensland Australia
    12 Royal Adelaide Hospital Adelaide South Australia Australia 5000
    13 Local Institution Clayton Victoria Australia 3168
    14 Department of Hematology and Stem Cell Transplantation, West German Cancer Center (WTZ) Essen Germany 45147
    15 Local Institution Jena Germany
    16 Local Institution Hong Kong Hong Kong
    17 Local Institution Alessandria Italy
    18 Local Institution Bologna Italy
    19 CRIMM; Centro Ricerca e Innovazione delle Malattia Mieloproliferative, Azienda ospedaliera Universitaria Careggi Florence Italy 50139
    20 Local Institution Varese Italy
    21 Local Institution Auckland New Zealand
    22 Middlemore Hospital Auckland New Zealand
    23 Local Institution London United Kingdom NW1
    24 Guys and St Thomas Hospital London United Kingdom SE1 9RT
    25 Local Institution London United Kingdom W12
    26 Local Institution Oxford United Kingdom

    Sponsors and Collaborators

    • Imago BioSciences,Inc.

    Investigators

    • Study Director: Hugh Rienhoff, MD, Imago BioSciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Imago BioSciences,Inc.
    ClinicalTrials.gov Identifier:
    NCT04254978
    Other Study ID Numbers:
    • IMG-7289-CTP-201
    First Posted:
    Feb 5, 2020
    Last Update Posted:
    Apr 18, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Thrombocytosis
    Thrombocythemia, Essential

    Study Results

    No Results Posted as of Apr 18, 2022