NCT01108705终止3 期
A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Asian Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2010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
- 终止
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- 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 whether brivanib is an effective treatment for liver cancer in Asian patients who have failed or could not tolerate sorafenib 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
- •Diagnosis of advanced hepatocellular carcinoma
- •Asian ethnicity
- •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 performance status of 0, 1, or 2
- •Life expectancy of at least 8 weeks
- •Adequate hematologic, hepatic, and renal function
排除标准
- •Women of childbearing potential 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
- •Inability to swallow tablets or untreated malabsorption syndrome
- •History of HIV infection
- •Prior use of systemic investigational agents for hepatocellular carcinoma (except sorafenib)
研究组 & 干预措施
Brivanib
Experimental
干预措施: Brivanib (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
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: Every 6 weeks for an average of 6 months
次要结局
- Compare time to progression (TTP) using modified RECIST for HCC(Every 6 weeks)
- Compare objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC(Every 6 weeks)
- Assess duration of response, duration of disease control and time to response(Every 6 weeks)
- Assess serious and nonserious adverse events, laboratory evaluations, significant physical examination findings and ECG results(Every 6 weeks)
研究者
研究点 (1)
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