Bomedemstat in Patients With Polycythemia Vera

Sponsor
Imago BioSciences,Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05558696
Collaborator
(none)
20
1
19

Study Details

Study Description

Brief Summary

This is a Phase 2 open label study of an orally administered LSD1 inhibitor, bomedemstat (IMG-7289), in patients with polycythemia vera.

This study investigates the following:
  • The safety and tolerability of bomedemstat

  • The pharmacodynamic effect of bomedemstat

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This is a Phase 2 multi-center, open-label study evaluating the safety, efficacy, pharmacokinetics and pharmacodynamics of bomedemstat administered orally once daily in patients with polycythemia vera.

Patients will receive 36 weeks of dosing and may qualify for additional treatment thereafter.

Patients will be followed closely throughout the study for both Adverse Events by frequent monitoring of clinical signs and symptoms as well as safety labs. Efficacy and pharmacodynamic effects will be closely monitored by frequent hematology assessments of peripheral blood. Throughout dosing, transfusions or phlebotomy may be administered if needed in accordance with standard institutional guidelines.

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Multi-Center, Open Label Study to Assess the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Bomedemstat in Patients With Polycythemia Vera (PV)
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: bomedemstat

bomedemstat administered daily for 36 weeks

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

    Primary Outcome Measures

    1. Incidence of treatment-emergent adverse events [Assessed from baseline through 14 days after end of treatment]

      Incidence and severity of treatment-emergent adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE)

    2. Incidence of patients who achieve a reduction of hematocrit [Assessed serially at each visit from baseline through week 36]

      Incidence of patients who achieve a reduction of hematocrit (Hct) to <45% without phlebotomy.

    Secondary Outcome Measures

    1. Evaluate the duration of change in hematocrit [Assessed from baseline through week 36]

      Incidence of patients with a durable change of hematocrit to <45% without phlebotomy

    2. Pharmacodynamics of bomedemstat on platelet count [Assessed from baseline through week 36]

      Incidence and durability of reduction of platelet count

    3. Pharmacodynamics of bomedemstat on WBC [Assessed from baseline through week 36]

      Incidence and durability of reduction of white blood cell (WBC) count

    4. Incidence of thrombotic and hemorrhagic events [Assessed from baseline through week 36]

      Incidence of new thrombotic or hemorrhagic events

    5. Incidence of spleen volume reduction [Assessed from baseline through week 36]

      Incidence of achieving a reduction in spleen volume in patients with enlarged spleen at baseline

    6. Incidence of disease progression [Assessed from baseline through week 36]

      Incidence of progression to post-polycythemia vera myelofibrosis, myelodysplastic syndrome or transformation to acute myeloid leukemia

    7. Evaluate pharmacokinetics: maximum plasma concentration (Cmax) of bomedemstat [Assessed Day 1 up to Day 57]

      Calculate Cmax with sparse blood sampling

    8. Evaluate pharmacokinetics: exposure of bomedemstat [Assessed Day 1 up to Day 57]

      Calculate area under the curve (AUC) with sparse blood sampling

    9. Evaluate pharmacokinetics: half life of bomedemstat [Assessed Day 1 up to Day 57]

      Calculate half life (t 1/2) with sparse blood sampling

    10. Evaluate the change in patient reported symptoms on the MFSAF [Assessed from baseline through week 36]

      Change in patient-reported symptom burden as evaluated by the Myelofibrosis Symptom Assessment Form (MFSAF); scoring of 0-70 with higher scores representing a worse outcome

    11. Evaluate the change in patient reported symptoms on the PGIC [Assessed from week 12 through week 36]

      Change in patient-reported symptom burden as evaluated by Patients' Global Impression of Change (PGIC) scale

    12. Evaluate duration of change in patient-reported symptom burden [Assessed from baseline through week 36]

      Incidence of patients achieving a durable reduction of the MFSAF Score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosis of Polycythemia Vera per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms

    • Bone marrow fibrosis score of Grade 0 or Grade 1

    • Patients that have failed at least one standard cytoreductive therapy to lower hematocrit

    • Platelet count ≥250 x 10ˆ9/L

    • Absolute neutrophil count (ANC) ≥1.5 x 10ˆ9/L

    • Life expectancy >36 weeks.

    • Must have discontinued prior cytoreductive therapy for 2 weeks (4 weeks for interferon) prior to study drug initiation.

    Exclusion Criteria:
    • Eastern Cooperative Oncology Group (ECOG) performance status of 3 or greater

    • 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

    • Evidence of increased risk of bleeding, including known bleeding disorders

    • Other hematologic/biochemistry requirements, as per protocol

    • Pregnant or lactating females

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Imago BioSciences,Inc.

    Investigators

    • Study Director: Hugh Rienhoff, MD, Imago BioSciences,Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Imago BioSciences,Inc.
    ClinicalTrials.gov Identifier:
    NCT05558696
    Other Study ID Numbers:
    • IMG-7289-CTP-203
    First Posted:
    Sep 28, 2022
    Last Update Posted:
    Oct 26, 2022
    Last Verified:
    Sep 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
    Keywords provided by Imago BioSciences,Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 26, 2022