NCT00825955已完成3 期
A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib: The BRISK PS Study (Brivanib Study in HCC Patients at Risk Post Sorafenib)
Bristol-Myers Squibb20 个研究点 分布在 2 个国家目标入组 587 人开始时间: 2009年2月17日最近更新:
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
- 587
- 试验地点
- 20
- 主要终点
- To 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
研究概览
简要总结
The purpose of this study is to determine if Brivanib is an effective treatment for liver cancer in patients who have failed or could not take Sorafenib
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 disease defined as (i) disease not eligible for surgical or loco-regional therapy or (ii) disease progressive after surgical or loco-regional therapy
- •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 (ECOG) performance status 0, 1, 2
- •Subjects who have a life expectancy of at least 8 weeks
- •Adequate hematologic, hepatic, and renal function
排除标准
- •women of childbearing potential (WOCBP) 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
- •Any other hemorrhage/bleeding event > Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 within 4 weeks
- •Inability to swallow tablets or untreated malabsorption syndrome
- •History of human immunodeficiency virus (HIV) infection
- •Prior use of systemic investigational agents for HCC (except for Sorafenib)
研究组 & 干预措施
Brivanib
Experimental
干预措施: Brivanib (Drug)
Brivanib
Experimental
干预措施: Best Supportive Care (Procedure)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
Placebo
Placebo Comparator
干预措施: Best Supportive Care (Procedure)
结局指标
主要结局
To 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
时间窗: computerized tomography (CT)/ magnetic resonance imaging (MRI) every six weeks until progression or death
次要结局
- To assess duration of response, duration of disease control and time to response(6 weeks)
- To compare time to progression (TTP) (Investigator assessed using modified Response Evaluation Criteria In Solid Tumors (RECIST) for HCC criteria)(35 months)
- To compare the Independent Radiological Review Committee (IRRC) assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC criteria(35 months)
- To assess safety profile of brivanib. Safety will be assessed by the number of adverse events (AEs), serious adverse events (SAEs), periodic data monitoring committee (DMC) review(35 months)
研究者
研究点 (20)
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