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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Brivanib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01540461

CA182-064

Details and patient eligibility

About

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

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Arm: Brivanib

Experimental group

Treatment:

Drug: Brivanib