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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Asian Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib

Conditions
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Carcinoma, Hepatocellular

Intervention / Treatment
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* Drug: Brivanib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brivanib<br> | Drug: Brivanib<br>* Tablets, Oral, 800 mg, once daily, until disease progression or toxicity<br>* Other names: BMS-582664;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Tablets, Oral, 0mg, once daily, until disease progression or toxicity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare overall survival of subjects with advanced HCC who have progressed on/after or are intolerant to sorafenib and receive brivanib plus best supportive care (BSC) to those receiving placebo plus BSC |  | Every 6 weeks for an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare time to progression (TTP) using modified RECIST for HCC |  | Every 6 weeks | 
| Compare objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC |  | Every 6 weeks | 
| Assess duration of response, duration of disease control and time to response |  | Every 6 weeks | 
| Assess serious and nonserious adverse events, laboratory evaluations, significant physical examination findings and ECG results |  | Every 6 weeks |