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Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms

A Phase 1, Open-Label, Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms

NCT04279847•Incyte Corporation

View on ClinicalTrials.gov

Summary

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 (MF) and other myeloid neoplasms.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age 18 years and older at the time of signing the informed consent.
•Part 1 Monotherapy: Participants with confirmed diagnosis of relapsed or refractory MF (primary, or post-PV and post-ET), MDS, MDS/MPN, or ET who have received at least 1 prior line of therapy; are either refractory, relapsed, or intolerant to the last therapy; and there is no available therapy that would provide clinical benefit in the opinion of the investigator.
•* a. MF with measurable disease (palpable spleen and symptoms) as defined in the protocol and risk category of intermediate 2 or high according to DIPSS. MF participants must have received a JAK inhibitor(s), such as ruxolitinib.
•* b. ET participants should have disease refractory to hydroxyurea as defined by the protocol.
•Part 2 Combination with ruxolitinib.
•* a. Primary MF or secondary MFs (post-PV MF and post-ET MF), histologically or cytologically confirmed, with measurable disease (palpable spleen and symptoms) as defined in the protocol, either currently receiving ruxolitinib with suboptimal response or JAKi-naive.
•* b. Suboptimal response is defined as currently being treated with ruxolitinib monotherapy at a stable dose for ≥ 8 weeks immediately preceding the first dose of study treatment. One dose reduction due to toxicities within 8 weeks prior to Study Day 1 is permitted.
•* c. JAKi-naive is defined as those participants that have no prior use of any JAK inhibitor, including ruxolitinib, and;
•* d. Part 2 dose escalation: Risk category of intermediate-2 or high according to DIPSS.
•* e. Part 2 dose expansion: Risk category of intermediate-1, intermediate-2, or high according to DIPSS.
+11 more criteria

Exclusion Criteria

•Prior receipt of a BET inhibitor.
•Receipt of anticancer medications or investigational drugs within the protocol-defined interval before the first dose of study treatment. For Part 2 JAKi-naive, prior use of a JAK inhibitor (including ruxolitinib) and no use of experimental drug therapy for MF or any other standard drug (except hydroxyurea) used for MF or another indication within 3 months of starting study drug. For participants with suboptimal response to ruxolitinib, ruxolitinib will continue at the participants' current ongoing doses, no ruxolitinib washout is needed.
•Participants with exclusionary laboratory values at screening defined as, including, but not limited to,
•* a. Platelets. Part 1 (monotherapy dose expansion, MF): \< 75 × 109/L. Part 1 (monotherapy dose expansion, ET): \< 450 × 109/L. Part 2 (combination dose escalation and expansion): \< 75 × 109/L. Part 2 (combination dose expansion, JAKi-naïve MF): \< 100 × 109/L.
•* b. Hemoglobin: Participants unwilling to receive red blood cell transfusion to treat low hemoglobin levels are excluded.
•* c. ANC \< 0.75 × 109/L.
•inadequate renal, hepatic and coagulation functions as defined in the protocol.
•Concurrent anticancer therapy other than the therapies being tested in this study.
•Participants who have received allogeneic hematopoietic stem cell transplantation within 6 months of enrollment (unless approved by the medical monitor), or have active graft versus-host disease, or have received immunosuppressive therapy following allogeneic transplant within 2 weeks of the first dose of study treatment.
•Unless approved by the medical monitor, may not have received autologous hematopoietic stem-cell transplant within 3 months before the first dose of study treatment.
+3 more criteria

Locations (48)

University of Alabama At Birmingham

Birmingham, Alabama, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Emory University-Winship Cancer Institute

Atlanta, Georgia, United States

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

Washington University School of Medicine

St Louis, Missouri, United States

Rutgers Cancer Institute of Nj

New Brunswick, New Jersey, United States

Nyu Langone Health - Long Island Hospital

Mineola, New York, United States

Nyu Langone Laura and Isaac Perlmutter Cancer Center

New York, New York, United States

Weill Medical College of Cornell University

New York, New York, United States

Key Dates

Start Date

February 23, 2021

Primary Completion Date

April 30, 2027

Completion Date

April 30, 2027

Last Updated

February 25, 2026

Enrollment

140

ACTUAL participants

Conditions

MyelofibrosisMyelodysplastic SyndromeMyelodysplastic/Myeloproliferative Neoplasm Overlap SyndromeMyeloproliferative NeoplasmRelapsed or Refractory Primary MyelofibrosisSecondary Myelofibrosis (Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis)ET (Essential Thrombocythemia)

Interventions

INCB057643

DRUG

Ruxolitinib

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 25, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms

Inclusion Criteria

Exclusion Criteria

Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis

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