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INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders
Sponsor: Incyte Corporation
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.
Official title: A Phase 1/2 Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2021-03-19
Completion Date
2027-11-26
Last Updated
2025-12-23
Healthy Volunteers
No
Interventions
INCB000928
INCB000928 will be administered at protocol defined dose.
ruxolitinib
Ruxolitinib will be administered at protocol defined dose.
Locations (34)
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