Determine the Pharmacokinetics and Safety of Brivanib in Chinese Subjects With Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC)

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of Brivanib in Chinese subjects with Advanced Hepatocellular Carcinoma (HCC).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

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

Inclusion Criteria:

Subjects with:

• Confirmed Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC)

• Not having received prior systemic treatment for advanced HCC

• Normal or moderately impaired liver function (Child-Pugh Class A or B (CP total score of ≤ 7))

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

Subjects with:

• Brain metastasis or evidence of leptomeningeal disease

• History of impaired brain function (encephalopathy) or active heart disease

• Unmanageable fluid in the abdomen (ascites)

• Bleeding esophageal or gastric varices within 2 months prior to inclusion