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Brief Title: To Assess the Safety and Tolerability of INCB000928 in Participants With Myelodysplastic Syndromes or Multiple Myeloma
Official Title: A Phase 1/2, Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy in Participants With Anemia Due to Myelodysplastic Syndromes or Multiple Myeloma
Study ID: NCT04582539
Brief 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 in participants with MDS or MM who are transfusion-dependent or present with symptomatic anemia.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Stanford Cancer Center, Palo Alto, California, United States
University of Miami, Miami, Florida, United States
Florida Cancer Specialists, Sarasota, Florida, United States
Tulane Comprehensive Cancer Center, New Orleans, Louisiana, United States
Barbara Ann Karmanos Cancer Hospital, Detroit, Michigan, United States
University of Cincinnati, Cincinnati, Ohio, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Md Anderson Cancer Center, Houston, Texas, United States
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu, Nantes, , France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud, Pierre Benite, , France
Institut Gustave Roussy, Villejuif, , France
L Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi, Bologna, , Italy
Azienda Ospedaliero-Universitaria Careggi (Aouc), Firenze, , Italy
Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo, Pavia, , Italy
Irccs Istituto Clinico Humanitas, Rozzano, , Italy
Name: Ekatarine Asatiani, MD
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR