First Line Hepato Cellular Carcinoma (HCC)

Study Overview
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Brief Summary
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The purpose of this study is to compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic therapy.

Official Title
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A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Versus Sorafenib as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

Conditions
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Hepato Cellular Carcinoma (HCC)

Intervention / Treatment
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* Drug: Brivanib
* Drug: Placebo
* Drug: Sorafenib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: Histologic or cytologic confirmed diagnosis of HCC. Advanced HCC: disease not eligible for surgical and/or locoregional therapies OR progressive disease after surgical and/or locoregional therapies Child-Pugh Class A ECOG performance status 0-1 Adequate hematologic, hepatic, and renal function Exclusion Criteria: Prior use of any systemic anti-cancer chemotherapy, immunotherapy or molecular targeted agents for HCC History of active cardiac disease Thrombotic or embolic events within the past 6 months (except HCC tumor thrombus) Any other hemorrhage/bleeding event >= CTCAE Grade 3 within 8 weeks except for esophageal or gastric varices Inability to swallow tablets or untreated malabsorption syndrome

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 |
| --- | --- |
| Active Comparator: Brivanib<br> | Drug: Brivanib<br>* Tablets, Oral, 800 mg, Once Daily, Until disease progression or unacceptable toxicity<br>* Other names: BMS-582664;Drug: Placebo<br>* Capsules, Oral, twice Daily, Until disease progression or unacceptable toxicity<br>|
| Active Comparator: Sorafenib<br> | Drug: Sorafenib<br>* Capsules, Oral, 800 mg, twice daily, Until disease progression or unacceptable toxicity<br>Drug: Placebo<br>* Tablets, Oral, Once Daily, Until disease progression or unacceptable toxicity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic treatment |  | Survival will be assessed continuously | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the time to progression (TTP) (investigator assessed using modified RECIST criteria for HCC |  | Every 6 weeks | 
| To compare the investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST criteria for HCC |  | Every 6 weeks | 
| To determine duration of response, duration of disease control, and time to response (TTR) |  | Every 6 weeks | 
| To assess the safety profile of brivanib and sorafenib |  | Every 6 weeks | 
| To explore PK and exposure-response in the study population |  | Every 6 weeks | 
| To compare time to symptomatic progression |  | Every 6 weeks | 
| To compare health-related quality of life |  | Every 6 weeks |