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

Clinical Trial Details

This clinical trial is for men and women with myelofibrosis.
   
The purpose of this study is to test the safety and tolerability of INCB057643 in combination with ruxolitinib on people with myelofibrosis. 
   
INCB057643 is experimental, which means that it is being tested and is not approved by the United States Food and Drug Administration (FDA). Ruxolitinib has been approved by the FDA for the treatment of different rare blood disorders called Myelofibrosis (MF), including Primary Myelofibrosis (PMF), Post Polycythemia Vera Myelofibrosis (PPV-MF), Post Essential Thrombocythemia Myelofibrosis (PET-MF), Polycythemia vera and acute, and chronic GvHD.
   
There are 2 parts to this study. Part 1 participants will receive INCB057643 and Part 2 participants will receive a combination of INCB057643 and ruxolitinib dose escalation and expansion.
   
It is estimated that an individual will receive study drug administration for approximately 9 months. The overall study duration is estimated to be approximately 24 months. This includes up to 28 days for screening, study drug administration in consecutive 28-day cycles as long as participants are receiving benefits and have not met any criteria for study withdrawal, and 30 to 35 days for safety follow-up after the last dose of the study drug.

Key Eligibility: 
  1. Open to men and women above the age of 18 who have been diagnosed with relapsed or refractory myelofibrosis (primary, or post-PV and post-ET), myelodysplastic syndrome, myelodysplastic syndrome/myeloproliferative neoplasm, or essential thrombocythemia who have received at least 1 prior line of therapy
  2. Participants must not have received prior treatment with bromodomain and extraterminal inhibitor.

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Victoria Mendez
212-746-4829
vib9049@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2401026949

ClinicalTrials.gov:

NCT04279847

Sponsor:

INCB 57643-103

Status

Open to Enrollment

Age Group

Adult

Sponsor