Comparison of Brivanib and Best Supportive Care (BSC) With Placebo and BSC for Treatment of Liver Cancer in Asian Patients Who Have Failed Sorafenib Treatment (BRISK-APS)

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 3

Conditions: Carcinoma, Hepatocellular

Treatments: Drug: Placebo; Drug: Brivanib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01108705

CA182-047

Details and patient eligibility

About

The purpose of this study is to determine whether brivanib is an effective treatment for liver cancer in Asian patients who have failed or could not tolerate sorafenib therapy.

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Diagnosis of advanced hepatocellular carcinoma
• Asian ethnicity
• Patient has failed ≥14 days of sorafenib treatment
• Cirrhotic status of Child-Pugh Class A or B with a score of 7
• Eastern Cooperative Oncology Group performance status of 0, 1, or 2
• Life expectancy of at least 8 weeks
• Adequate hematologic, hepatic, and renal function

Key Exclusion Criteria:

• Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy
• Previous or concurrent cancer that is distinct in primary site
• History of active cardiac disease
• Thrombotic or embolic events within the past 6 months
• Inability to swallow tablets or untreated malabsorption syndrome
• History of HIV infection
• Prior use of systemic investigational agents for hepatocellular carcinoma (except sorafenib)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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87 participants in 2 patient groups, including a placebo group

Brivanib

Experimental group

Treatment:

Drug: Brivanib

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo