INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders

Last updated: October 23, 2023
Sponsor: Incyte Corporation
Overall Status: Active - Recruiting

Phase

1/2

Condition

Post-essential Thrombocythemia Myelofibrosis

Anemia

Post-polycythemia Vera Myelofibrosis

Treatment

Ruxolitinib

INCB000928

Clinical Study ID

NCT04455841
INCB 00928-104
  • Ages > 18
  • All Genders

Study Summary

This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy or in combination with ruxolitinib in participants with MF who are transfusion-dependent or presenting with symptomatic anemia. This study will consist of 2 parts: dose escalation and expansion.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants with MF who are transfusion-dependent or present with symptomatic anemia, defined as follows:
  1. Anemia: An Hgb value < 10 g/dL demonstrated during screening recorded on 3 separate occasions with at least 7 days between measurements (Note: RBC transfusion must be at least 2 weeks before the Hgb measurement during screening).
  2. Transfusion-dependent: Participant has received at least 4 units of RBC transfusions during the 28 days immediately preceding Cycle 1 Day 1 OR has received an average of at least 4 units of RBC transfusions in the 8 weeks immediately preceding Cycle 1 Day 1, for an Hgb level of < 8.5 g/dL, in the absence of bleeding or treatment-induced anemia. In addition, the most recent transfusion episode must have occurred in the 28 days before Cycle 1 Day 1.
  • ECOG performance status score of the following:
  1. 0 or 1 for the dose-escalation stages.
  2. 0, 1, or 2 for the dose-expansion stage.
  • Life expectancy is greater than 6 months
  • Agreement to avoid pregnancy or fathering children.
  • Ineligible to receive or have not responded to available therapies for anemia such as ESAs.
  • For TGA:
  • Participants previously treated with JAK inhibitors for at least 12 weeks.
  • Participants with intermediate-2 or high DIPSS MF according to IWG-MRT criteria.
  • For TGB:
  • Participants must have been on a therapeutic and stable regimen of ruxolitinib for at least 12 consecutive weeks immediately preceding the first dose of study treatment.
  • Participants with intermediate-1, intermediate-2, or high DIPSS MF according to IWG-MRT criteria.

Exclusion

Exclusion Criteria:

  • Undergone any prior allogenic or autologous stem cell transplantation or a candidate for such transplantation.
  • Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody or hypomethylating agent to treat the participant's disease, with the exception of ruxolitinib for TGB only, within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
  • Laboratory Values outside of protocol defined range at screening.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Ruxolitinib
Phase: 1/2
Study Start date:
March 19, 2021
Estimated Completion Date:
April 30, 2024

Study Description

Connect with a study center

  • Chiba Cancer Center

    Chiba, 260-8717
    Japan

    Active - Recruiting

  • Osaka International Cancer Institute

    Osaka-Shi, 541-8567
    Japan

    Active - Recruiting

  • Royal Cornwall Hospital Truro Sunrise Centre

    Truro, TR1 3LQ
    United Kingdom

    Active - Recruiting

  • City of Hope National Medical Center

    Duarte, California 91010
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.