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.
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
Drug | Synonyms | Arms |
---|
INCB057643 | | INCB057643 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
Name | Type | Description | Interventions |
---|
INCB057643 Monotherapy | Experimental | INCB057643 dose confirmation (Part 1) and dose expansion (Part 2). | |
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: | 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
August 4, 2021