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Spots Global Cancer Trial Database for Phase 1b/2 Study of Oprozomib in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma

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Trial Identification

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

Interventions

Oprozomib
Sorafenib

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: MD

Affiliation: Amgen

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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