A Randomized, Double-blind, Multi-center Phase III Study of Brivanib versus Sorafenib as First-line Treatment in Patients with Advanced Hepatocellular Carcinoma

Bristol Myers Squibb India Pvt Ltd12 个研究点分布在 1 个国家目标入组 1,714 人开始时间: 2009年8月31日最近更新: 2014年7月16日

试验速览

阶段: 3 期
状态: 已完成
发起方: Bristol Myers Squibb India Pvt Ltd
入组人数: 1,714
试验地点: 12
主要终点: To compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic treatment

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.Number of patients to be recruited from India :- 72 Patient recruitment started on 31st AUG 2009

研究设计

研究类型: Interventional
分配方式: Stratified block randomization
盲法: Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•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.

排除标准

•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.

结局指标

主要结局

To compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic treatment

时间窗: Time Frame: Survival will be assessed continuously Designated as safety issue: No

次要结局

To compare the time to progression (TTP) (investigator assessed using modified RECIST criteria To compare the investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST criteria To determine duration of response, duration of disease control, and time to response (TTR) To assess the safety profile of brivanib and sorafenibTo explore PK and exposure-response in the study populationTo compare time to symptomatic progressionTo compare health-related quality of life(Time frame for every secondary outcome is 6 weeks.Designated as safety issue: No)

研究者

发起方

Bristol Myers Squibb India Pvt Ltd

申办方类型

Pharmaceutical industry-Global

研究点 (12)

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