Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis
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.
- Relapsed or Refractory Primary Myelofibrosis
- Secondary Myelofibrosis (Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis)
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- 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).
- Phase 1
- Study Type
- Intervention Model
- Single Group Assignment
- Primary Purpose
- None (Open Label)
|INCB057643 dose confirmation (Part 1) and dose expansion (Part 2).||
- Incyte Corporation
Study ContactIncyte Corporation Call Center (US)