NCT00415155撤回1 期
An Open Label, Single Arm, Phase 1b/2 Study With Pharmacokinetic Sampling to Evaluate LY2181308 in Patients With Advanced Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Phase 1: Determine recommended dose
研究概览
简要总结
The primary objective of this study is to estimate the time to progressive disease for patients with advanced hepatocellular cancer who receive LY2181308.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Diagnosed with hepatocellular cancer
- •Discontinued all previous therapies
- •At least 18 years of age
排除标准
- •Have other treatment options that are potentially curative or effective--such as surgical resection, liver transplant or percutaneous ablation, and/or transcatheter arterial embolization.
- •Transplanted liver
- •HIV positive
- •More than 2 previous systemic chemotherapy treatments
研究组 & 干预措施
A
Experimental
干预措施: LY2181308 (Drug)
结局指标
主要结局
Phase 1: Determine recommended dose
时间窗: every cycle
Phase 2: Time to progression
时间窗: baseline to measured progressive disease
次要结局
- Phase 1: Safety(every cycle)
- Phase 2: Overall Survival(Baseline to date of death from any cause)
- Phase 2: Response rate(Baseline to measured PD)
- Phase 2: Pharmacokinetics(Cycle 1 and Cycle 2)
- Phase 2: Safety(every cycle)
研究者
研究点 (1)
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