Clinical Trials /

Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis

NCT04279847

Description:

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of INCB057643 as monotherapy for participants with relapsed or refractory myelofibrosis.

Related Conditions:
  • Myelofibrosis
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis
  • Official Title: A Phase 1, Open-Label, Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis

Clinical Trial IDs

  • ORG STUDY ID: INCB 57643-103
  • NCT ID: NCT04279847

Conditions

  • Relapsed or Refractory Primary Myelofibrosis
  • Secondary Myelofibrosis (Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis)

Interventions

DrugSynonymsArms
INCB057643INCB057643 Monotherapy

Purpose

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of INCB057643 as monotherapy for participants with relapsed or refractory myelofibrosis.

Trial Arms

NameTypeDescriptionInterventions
INCB057643 MonotherapyExperimentalINCB057643 dose confirmation (Part 1) and dose expansion (Part 2).
  • INCB057643

Eligibility Criteria

        Inclusion Criteria:

          -  Relapsed or refractory primary myelofibrosis (MF) or secondary MFs (post-polycythemia
             vera MF, post-essential thrombocythemia MF).

          -  Must not be a candidate for potentially curative therapy, including hematopoietic
             stem-cell transplantation.

          -  Willingness to undergo a pretreatment bone marrow biopsy and/or aspirate at
             screening/baseline, or archival sample obtained since completion of most recent
             therapy.

          -  Willingness to avoid pregnancy or fathering children.

        Exclusion Criteria:

          -  Prior receipt of any BET inhibitor.

          -  Have received allogeneic hematopoietic stem-cell transplant within 6 months of
             enrollment or have active graft-versus-host disease, or have received
             immunosuppressive therapy following allogeneic transplant within 2 weeks of Cycle 1
             Day 1.

          -  Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half lives
             (whichever is longer) before the first dose of study drug.

          -  History of bleeding disorder or at a high risk of bleeding (eg, chronic liver disease,
             prior gastrointestinal bleed).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of treatment-emergent adverse events
Time Frame:Up to approximately 9 months
Safety Issue:
Description:Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.

Secondary Outcome Measures

Measure:Rate of anemia response
Time Frame:Up to approximately 9 months
Safety Issue:
Description:Anemia response defined by International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European LeukemiaNet (ELN) Consensus Report
Measure:Red blood cell (RBC) transfusion independence rate
Time Frame:Up to approximately 9 months
Safety Issue:
Description:Assessed by need for transfusion support
Measure:Rate of converting from RBC transfusion dependence to independence
Time Frame:Up to approximately 9 months
Safety Issue:
Description:Assessed by need for transfusion support
Measure:RBC transfusion frequency per participant
Time Frame:Up to approximately 9 months
Safety Issue:
Description:Assessed by need for transfusion support
Measure:RBC transfusion frequency per month
Time Frame:Up to approximately 9 months
Safety Issue:
Description:Assessed by need for transfusion support
Measure:Hemoglobin improvement
Time Frame:Up to approximately 9 months
Safety Issue:
Description:Defined as hemoglobin level increase ≥ 1.5 g/dL or hemoglobin level ≥ 8.5 g/dL)
Measure:Best spleen volume percentage change from baseline
Time Frame:12 weeks
Safety Issue:
Description:Measured by imaging
Measure:Percent of participants with spleen volume reduction of 35% or more
Time Frame:Up to approximately 9 months
Safety Issue:
Description:Assessed by imaging measurements and calculating the differences from image to image
Measure:Rate of spleen response by imaging
Time Frame:24 weeks
Safety Issue:
Description:Defined by IWG-MRT and ELN Consensus Report
Measure:Time from spleen response to progressive disease
Time Frame:Up to approximately 9 months
Safety Issue:
Description:Based on splenomegaly as defined by IWG-MRT and ELN Consensus Report
Measure:Percent of participants achieving 50% or more improvement in total symptom score
Time Frame:Up to approximately 9 months
Safety Issue:
Description:Based on the Myeloproliferative Neoplasms Symptom Assessment Form Total Symptom Score questionnaire.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • Myelofibrosis
  • BET protein inhibitor
  • relapsed primary myelofibrosis
  • refractory primary myelofibrosis
  • secondary myelofibrosis
  • post-polycythemia vera myelofibrosis
  • post-essential thrombocythemia myelofibrosis

Last Updated

February 20, 2020