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

ArmDescriptionAssigned 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