NCT01009593终止3 期
An Open-label, Randomized Phase 3 Study of the Efficacy and Tolerability of Linifanib (ABT-869) Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)
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
- Abbott
- 入组人数
- 1,035
- 试验地点
- 163
- 主要终点
- Overall Survival
研究概览
简要总结
The primary objective of this study is to assess the overall survival (OS) of oral linifanib given as monotherapy once daily (QD) compared to sorafenib given twice daily (BID) per standard of care in subjects with advanced or metastatic HCC.
详细描述
The IDMC recommended discontinuation of the study, and, the protocol was amended to end study treatment.
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
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ABT-869
Experimental
干预措施: ABT-869 (Drug)
Sorafenib
Active Comparator
干预措施: Sorafenib (Drug)
结局指标
主要结局
Overall Survival
时间窗: From randomization until patient death; assessed monthly
次要结局
- Time To Progression (TTP)(From randomization until patient progression; assessed every 6 weeks)
- Overall Response Rate (ORR)(Assessed Every 6 weeks)
研究者
研究点 (163)
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