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

Bristol-Myers Squibb17 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Hepatocellular Carcinoma

Interventions

BrivanibDRUG

Tablets, Oral, 800 mg, Once daily, Until withdrawal of consent, disease progression or until unmanageable toxicity

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Local Institution

Beijing, Beijing Municipality, China

Local Institution

Harbin, Heilongjiang, China

Local Institution

Nanjing, Jiangsu, China