First Line Hepato Cellular Carcinoma (HCC)

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Sorafenib

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• Histologic or cytologic confirmed diagnosis of HCC.

• Advanced HCC: disease not eligible for surgical and/or locoregional therapies OR progressive disease after surgical and/or locoregional therapies

• Child-Pugh Class A

• ECOG performance status 0-1

• Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

• Prior use of any systemic anti-cancer chemotherapy, immunotherapy or molecular targeted agents for HCC

• History of active cardiac disease

• Thrombotic or embolic events within the past 6 months (except HCC tumor thrombus)

• Any other hemorrhage/bleeding event >= CTCAE Grade 3 within 8 weeks except for esophageal or gastric varices

• Inability to swallow tablets or untreated malabsorption syndrome