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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

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

ArmDescriptionAssigned Intervention
Experimental
INCB057643 Monotherapy 		INCB057643 dose escalation (Part 1) and dose expansion (Part 2: treatment group A).
  • Drug: INCB057643
    INCB057643 dose escalation (Part 1) and dose expansion (Part 2).
Experimental
INCB057643 Combination with Ruxolitinib 		Combination arm in dose escalation (Part 1) and dose expansion (Part 2: Treatment Group B)
  • Drug: INCB057643
    INCB057643 dose escalation (Part 1) and dose expansion (Part 2).
  • Drug: Ruxolitinib
    Ruxolitinib will be administered twice a day using the dose designated as the stable dose at the time of the screening visit for each subject. Acceptable doses are 5 mg BID to 25 mg BID.

Recruiting Locations

University of Alabama At Birmingham
Birmingham, Alabama 35294

More Details

Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

Incyte Corporation Call Center (US)
1.855.463.3463
medinfo@incyte.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.