Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms
Purpose
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of INCB057643 as monotherapy or combination with ruxolitinib for participants with myelofibrosis and other myeloid neoplasms.
Conditions
- Myelofibrosis
- Myelodysplastic Syndrome
- Myelodysplastic/Myeloproliferative Neoplasm Overlap Syndrome
- Myeloproliferative Neoplasm
- Relapsed or Refractory Primary Myelofibrosis
- Secondary Myelofibrosis (Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Relapsed or refractory primary myelofibrosis (MF), secondary MFs (post-polycythemia vera MF, post- essential thrombocythemia MF) myeloproliferative neoplasm (MPN), myelodysplastic syndrome (MDS), and myelodysplastic/myeloproliferative neoplasm overlap syndrome (MDS/MPN) - 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 a BET inhibitor within 5 half-lives of the compound, and/or experienced BET inhibitor-related AE(s) resulting in dose discontinuation. - Receipt of anticancer medications or investigational drugs within the protocol-defined interval before the first dose of study treatment: Note: For participants in Part 2, Treatment Group B, ruxolitinib will continue at the participants' current, ongoing doses. No ruxolitinib washout is needed.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- monotherapy and ruxoltinib combination
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental INCB057643 Monotherapy |
INCB057643 dose escalation (Part 1) and dose expansion (Part 2: treatment group A). |
|
Experimental INCB057643 Combination with Ruxolitinib |
Combination arm in dose escalation (Part 1) and dose expansion (Part 2: Treatment Group B) |
|
Recruiting Locations
University of Alabama At Birmingham
Birmingham, Alabama 35294
Birmingham, Alabama 35294
More Details
- Status
- Recruiting
- Sponsor
- Incyte Corporation