INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders
NCT ID: NCT04455841
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
84 participants
INTERVENTIONAL
2021-03-19
2027-11-26
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Treatment Group A (TGA)
INCB000928 will be administered once daily (QD).
INCB000928
INCB000928 will be administered at protocol defined dose.
Treatment Group B (TGB)
INCB000928 will be administered in combination with ruxolitinib.
INCB000928
INCB000928 will be administered at protocol defined dose.
ruxolitinib
Ruxolitinib will be administered at protocol defined dose.
Treatment Group C (TGC)
INCB000928 will be administered in combination with ruxolitinib.
INCB000928
INCB000928 will be administered at protocol defined dose.
ruxolitinib
Ruxolitinib will be administered at protocol defined dose.
Interventions
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INCB000928
INCB000928 will be administered at protocol defined dose.
ruxolitinib
Ruxolitinib will be administered at protocol defined dose.
Eligibility Criteria
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Inclusion Criteria
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.
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Amanda McBride, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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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
Chiba Cancer Center
Chiba, , Japan
Gifu Municipal Hospital
Gifu, , Japan
Kansai Medical University Hospital
Hirakata, , Japan
Kumamoto Shinto General Hospital
Kumamoto, , Japan
Osaka International Cancer Institute
Osaka, , Japan
University Hospital of Wales
Cardiff, WLS, United Kingdom
United Lincolnshire Hospitals
Boston, , United Kingdom
Lincoln County Hospital
Lincoln, , United Kingdom
Royal Cornwall Hospital Truro Sunrise Centre
Truro, , United Kingdom
Countries
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Related Links
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Related Info
Other Identifiers
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2023-503625-19-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-004029-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 00928-104
Identifier Type: -
Identifier Source: org_study_id