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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Anemia, Post-essential Thrombocythemia Myelofibrosis, Post-polycythemia Vera Myelofibrosis

In brief

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.

Key facts

Study ID

NCT04455841

Run by

Incyte Corporation

People needed

84

Starts

2021-03-19

Expected to finish

2027-11-26

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with MF who are transfusion-dependent or present with symptomatic anemia, defined as follows:
• 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).
• 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:
• 0 or 1 for the dose-escalation stages.
• 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.
• For TGC:
• Participants must be JAK inhibitor treatment naive (no prior treatment with any JAK inhibitor) and have an indication for initiation of ruxolitinib treatment.
• Participants with intermediate-1, intermediate-2, or high DIPSS MF according to IWG-MRT criteria.

You may not qualify if…

• 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.

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• City of Hope Orange County — Irvine, California, United States
• Usc Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Stanford Cancer Center — Palo Alto, California, United States
• Prebys Cancer Center — San Diego, California, United States
• Emory University - Winship Cancer Institute — Atlanta, Georgia, United States
• Emory University-Winship Cancer Institute — Atlanta, Georgia, United States
• Start Midwest — Grand Rapids, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Weill Cornell Medical Centers — New York, New York, United States
• Duke University Medical Center, Department of Hematologic Malignancies and Cellular Therapy — Durham, North Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Md Anderson Cancer Center — Houston, Texas, United States
• Princess Margaret Cancer Center — Toronto, Ontario, Canada
• McGill University Jewish General Hospital — Montreal, Quebec, Canada
• Centre Hospitalier D'Angers — Angers, France
• Institut Paoli Calmettes — Marseille, France
• Hospital Saint Louis — Paris, France
• Azienda Ospedaliera Papa Giovanni Xxiii — Bergamo, Italy
• S Orsolas University Hospital Seragnoli Institute of Hematology — Bologna, Italy
• Azienda Ospedaliero-Universitaria Careggi (Aouc) — Florence, Italy
• Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano — Orbassano, Italy
• Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo — Pavia, Italy
• Ospedale Santa Maria Della Misericordia Perugia — Perugia, Italy
• Tokyo Medical and Dental University Hospital — Bunkyō City, Japan

Full record on ClinicalTrials.gov

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