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

Last updated: May 2, 2025
Sponsor: Incyte Corporation
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Anemia

Post-essential Thrombocythemia Myelofibrosis

Thrombosis

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 symptomaticanemia, defined as follows:
  1. Anemia: An Hgb value < 10 g/dL demonstrated during screening recorded on 3separate occasions with at least 7 days between measurements (Note: RBCtransfusion must be at least 2 weeks before the Hgb measurement duringscreening).

  2. Transfusion-dependent: Participant has received at least 4 units of RBCtransfusions during the 28 days immediately preceding Cycle 1 Day 1 OR hasreceived an average of at least 4 units of RBC transfusions in the 8 weeksimmediately preceding Cycle 1 Day 1, for an Hgb level of < 8.5 g/dL, in theabsence of bleeding or treatment-induced anemia. In addition, the most recenttransfusion 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 suchas 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 forat least 12 consecutive weeks immediately preceding the first dose of studytreatment.

  • Participants with intermediate-1, intermediate-2, or high DIPSS MF according toIWG-MRT criteria.

  • For TGC:

  • Participants must be JAK inhibitor treatment naive (no prior treatment with any JAKinhibitor) and have an indication for initiation of ruxolitinib treatment.

  • Participants with intermediate-1, intermediate-2, or high DIPSS MF according toIWG-MRT criteria.

Exclusion

Exclusion Criteria:

  • Undergone any prior allogenic or autologous stem cell transplantation or a candidatefor such transplantation.

  • Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy,biological therapy, endocrine therapy, targeted therapy, antibody or hypomethylatingagent to treat the participant's disease, with the exception of ruxolitinib for TGBonly, within 5 half-lives or 28 days (whichever is shorter) before the first dose ofstudy treatment.

  • Laboratory Values outside of protocol defined range at screening.

Study Design

Total Participants: 84
Treatment Group(s): 2
Primary Treatment: ruxolitinib
Phase: 1/2
Study Start date:
March 19, 2021
Estimated Completion Date:
October 15, 2025

Connect with a study center

  • Princess Margaret Cancer Center

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • McGill University Jewish General Hospital

    Montreal, Quebec H3T1E2
    Canada

    Site Not Available

  • St Paul'S Hospital

    Vancouver, V6Z2A5
    Canada

    Site Not Available

  • Centre Hospitalier D'Angers

    Angers Cedex 01, 49033
    France

    Site Not Available

  • Institut Paoli-Calmettes

    Marseille, 13009
    France

    Site Not Available

  • Institut Paoli Calmettes

    Marseille Cedex 9, 13273
    France

    Site Not Available

  • Institut Paoli-Calmettes

    Marseille Cedex 9, 13273
    France

    Active - Recruiting

  • Hospital Saint Louis

    Paris, 75010
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif, 94800
    France

    Site Not Available

  • Azienda Ospedaliera Papa Giovanni Xxiii

    Bergamo, 24127
    Italy

    Site Not Available

  • S Orsolas University Hospital Seragnoli Institute of Hematology

    Bologna, 40138
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Careggi (Aouc)

    Firenze, 50134
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano

    Orbassano, 10043
    Italy

    Site Not Available

  • Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo

    Pavia, 27100
    Italy

    Site Not Available

  • Ospedale Santa Maria Della Misericordia Perugia

    Perugia, 06124
    Italy

    Site Not Available

  • Tokyo Medical and Dental University Hospital

    Bunkyo-ku, 113-8519
    Japan

    Site Not Available

  • Chiba Cancer Center

    Chiba, 260-8717
    Japan

    Site Not Available

  • Gifu Municipal Hospital

    Gifu, 500-8513
    Japan

    Site Not Available

  • Kansai Medical University Hospital

    Hirakata, 573-1191
    Japan

    Site Not Available

  • Kumamoto Shinto General Hospital

    Kumamoto, 862-8655
    Japan

    Site Not Available

  • Osaka International Cancer Institute

    Osaka, 541-8567
    Japan

    Site Not Available

  • Osaka International Cancer Institute

    Osaka-shi, 541-8567
    Japan

    Site Not Available

  • University Hospital of Wales

    Cardiff, WLS CF14 4XW
    United Kingdom

    Site Not Available

  • United Lincolnshire Hospitals

    Boston, PE21 9QS
    United Kingdom

    Site Not Available

  • Lincoln County Hospital

    Lincoln, LN2 5QY
    United Kingdom

    Site Not Available

  • Churchill Hospital

    Oxford, OX3 7LE
    United Kingdom

    Site Not Available

  • Royal Cornwall Hospital Truro Sunrise Centre

    Truro, TR1 3LJ
    United Kingdom

    Site Not Available

  • Genesiscare Center

    Windsor, SL4 3HD
    United Kingdom

    Site Not Available

  • City of Hope National Medical Center

    Duarte, California 91010
    United States

    Site Not Available

  • City of Hope Orange County

    Irvine, California 92618
    United States

    Site Not Available

  • Usc Norris Comprehensive Cancer Center

    Los Angeles, California 90089
    United States

    Site Not Available

  • Stanford Cancer Center

    Palo Alto, California 94304
    United States

    Site Not Available

  • Prebys Cancer Center

    San Diego, California 92103
    United States

    Site Not Available

  • Emory University - Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Emory University-Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • Start Midwest

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Weill Cornell Medical Centers

    New York, New York 10065
    United States

    Site Not Available

  • Duke University Medical Center, Department of Hematologic Malignancies and Cellular Therapy

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Md Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

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