NCT00858871已完成3 期
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 Squibb13 个研究点 分布在 2 个国家目标入组 1,714 人开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,714
- 试验地点
- 13
- 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
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
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 (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
研究组 & 干预措施
Sorafenib
Active Comparator
干预措施: Placebo (Drug)
Brivanib
Active Comparator
干预措施: Brivanib (Drug)
Brivanib
Active Comparator
干预措施: Placebo (Drug)
Sorafenib
Active Comparator
干预措施: Sorafenib (Drug)
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: Survival will be assessed continuously
次要结局
- To compare the time to progression (TTP) (investigator assessed 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)
- To compare the investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST criteria for HCC(Every 6 weeks)
研究者
研究点 (13)
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