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Brief Title: Phase 1b/2 Study of Oprozomib in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma
Official Title: Phase 1b/2 Study of Oprozomib in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma
Study ID: NCT02227914
Brief Summary: The purpose of Phase 1b of the study is to determine the maximum tolerated dose, pharmacokinetics (PK) and pharmacodynamics (PDn) and assess the safety, tolerability and activity of oprozomib in combination with sorafenib in subjects with advanced hepatocellular carcinoma (HCC). The purpose of Phase 2 of the study is to evaluate the efficacy of oprozomib in combination with sorafenib versus sorafenib alone and to compare the key outcome measures for subjects with advanced HCC.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Lahey Hospital & Medical Center, Burlington, California, United States
Rocky Mountain Cancer Centers, Denver, Colorado, United States
University of Miami Hospital & Clinics, Miami, Florida, United States
The University of Chicago Medical Center, Chicago, Illinois, United States
The Ohio State University, Martha Morehouse Medical Plaza, Columbus, Ohio, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR