65
Participants
Start Date
July 2, 2013
Primary Completion Date
June 25, 2019
Study Completion Date
June 25, 2019
Oprozomib
Oprozomib tablets were supplied containing 60, 90, or 120 mg of oprozomib. Oprozomib extended release tablets were supplied containing 150, 180, 210, 240, or 270 mg of oprozomib. Both formulations were administered in a single dose on dosing days. The tablet formulation required multiple tablets to reach each dose on dosing days.
Dexamethasone
Dexamethasone was administered as 20 mg tablets in strengths of 4 and 6 mg taken orally. If a participant could not tolerate tablets or tablets were unavailable, 20 mg administered intravenously was substituted.
USC/Norris Comprehensive Cancer Center, Los Angeles
H. Lee Moffitt Cancer Center & Research Institute, Tampa
University of Kansas Cancer Center and Medical Pavilion, Westwood
Center for Cancer and Blood Disorders, Bethesda
Dana-Farber Cancer Institute, Boston
Massachusetts General Hospital, Boston
Karmanos Cancer Institute, Detroit
Division of Hematology/ Oncology, UNC at Chapel Hill, Chapel Hill
Gabrail Cancer Center Research, Canton
Froedtert Hospital and the Medical College of Wisconsin, Milwaukee
CHRU, Hopital Huriez - Department of Hematology, Lille
CHU Hotel Dieu - Service d'Hematologie Clinique, Nantes
CHU de NANCY - Hopital de BRABOlS, Vandœuvre-lès-Nancy
Lead Sponsor
Amgen
INDUSTRY