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IMG-7289 in Patients With Essential Thrombocythemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04254978
Recruitment Status : Active, not recruiting
First Posted : February 5, 2020
Last Update Posted : April 18, 2022
Sponsor:
Information provided by (Responsible Party):
Imago BioSciences,Inc.

Study Description
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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
Essential Thrombocythemia Drug: IMG-7289 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Multi-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 : September 20, 2020
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: IMG-7289
IMG-7289 administered daily for 169 consecutive days
 Drug: IMG-7289
LSD1 inhibitor
Other Name: bomedemstat


Outcome Measures
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Primary Outcome Measures :
  1. The safety of IMG-7289 when administered to patients with essential thrombocythemia [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04254978


Locations
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Sponsors and Collaborators
Imago BioSciences,Inc.
Investigators
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Study Director: Hugh Rienhoff, MD Imago BioSciences
More Information
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Responsible Party: Imago BioSciences,Inc.
ClinicalTrials.gov Identifier: NCT04254978    
Other Study ID Numbers: IMG-7289-CTP-201
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: April 18, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thrombocytosis
Thrombocythemia, Essential
Blood Platelet Disorders
Hematologic Diseases
 Myeloproliferative Disorders
Bone Marrow Diseases
Blood Coagulation Disorders
Hemorrhagic Disorders