UAB - Center for Clinical and Translational Science

Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis

Purpose

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.

Conditions

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) 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.

Exclusion Criteria

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).

Study Design

Phase: Phase 1
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental INCB057643 Monotherapy	INCB057643 dose confirmation (Part 1) and dose expansion (Part 2).	Drug: INCB057643 INCB057643 dose confirmation (Part 1) and dose expansion (Part 2).

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.