BRISK - F
Phase 3
Completed
- Conditions
- Health Condition 1: null- Advanced Hepatocellular Carcinoma
- Registration Number
- CTRI/2009/091/000276
- Lead Sponsor
- Bristol Myers Squibb India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1714
Inclusion Criteria
Histologic or cytologic confirmed diagnosis of HCC. Advanced HCC
Disease not eligible for surgical and / or locoregional therapies
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
Any other hemorrhage/bleeding event >= CTCAE Grade 3 within 4 weeks except for esophageal or gastric varices
Inability to swallow tablets or untreated malabsorption syndrome
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic treatment <br>Timepoint: Time Frame: Survival will be assessed continuously Designated as safety issue: No<br>
- Secondary Outcome Measures
Name Time Method To compare the time to progression (TTP) (investigator assessed using modified RECIST criteria <br>To compare the investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST criteria <br>To determine duration of response, duration of disease control, and time to response (TTR) <br>To assess the safety profile of brivanib and sorafenib<br>To explore PK and exposure-response in the study population<br>To compare time to symptomatic progression<br>To compare health-related quality of life <br>Timepoint: Time frame for every secondary outcome is 6 weeks.<br><br>Designated as safety issue: No <br><br>