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Brief Title: Safety and Efficacy Study of CC-122 Combined With Sorafenib for Primary Liver Cancer
Official Title: A Phase 1b, Multi-Center, Open-Label, Dose Finding Study of CC-122 in Combination With Sorafenib in Subjects With Unresectable Hepatocellular Carcinoma
Study ID: NCT02323906
Brief Summary: CC-122-HCC-001 is a Phase 1b dose escalation and expansion clinical study of CC-122 in combination with sorafenib for subjects with unresectable HCC who have received no prior systemic therapy for HCC. The dose escalation phase of the study will explore several dose levels of CC-122 in combination with sorafenib, followed by an expansion part of the study using the optimal combination dose regimen.
Detailed Description: The primary objective of the study is to determine the safety and tolerability of CC-122 administered orally in combination with sorafenib, and to define the non-tolerated dose (NTD), the maximum tolerated dose (MTD), and the recommended phase 2 dose (RP2D). The secondary objective of the study is to determine the preliminary efficacy of CC-122 in combination with sorafenib, based on response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of California San Francisco, San Francisco, California, United States
University of Florida College of Med, Gainesville, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
Henry Ford Hospital, Detroit, Michigan, United States
Greenville Hospital System, Greenville, South Carolina, United States
University of Utah Huntsman Cancer Institute, Salt Lake City, Utah, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Name: Kristen Hege, MD
Affiliation: Celgene Corporation
Role: STUDY_DIRECTOR