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ACTIVE NOT RECRUITING
NCT04455841
PHASE1/PHASE2

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

Sponsor: Incyte Corporation

View on ClinicalTrials.gov

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

DRUG

INCB000928

INCB000928 will be administered at protocol defined dose.

DRUG

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