A Multicenter, Open Label, Phase I /Randomised Phase II Study to Evaluate Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Comparison With Oral Sorafenib for Advanced Hepatocellular Carcinoma Patients.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 28
- 主要终点
- Maximum Tolerated Dose in Phase I
研究概览
简要总结
The study aim is to determine maximally tolerated dose (MTD) of BIBF 1120 in HCC (hepatocellular cancer) and compare efficacy of BIBF 1120 to Sorafenib in HCC patients
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
BIBF 1120
Phase I dose escalation and phase II using dose determined in phase I ( 200 mg BID)
干预措施: BIBF 1120 (Drug)
Sorafenib
干预措施: Sorafenib (Drug)
结局指标
主要结局
Maximum Tolerated Dose in Phase I
时间窗: 4 weeks
The MTD was defined as the highest dose studied for which the incidence of dose limiting toxicities (DLTs) was 0/3 or less than 2/6 patients during the first treatment course.
Time to Progression (TTP) in Phase II
时间窗: From randomization until data cut-off (15 July 2014); Up to 1031 days
TTP according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.0 criteria based on central independent review. TTP RECIST 1.0 was defined as the time from randomisation to disease progression according to RECIST 1.0.
次要结局
- Incidence of Dose Limiting Toxicity in Phase I(4 weeks)
- Objective Tumour Response by RECIST(From randomization until data cut-off (15 July 2014); Up to 1031 days)
- Progression Free Survival (PFS)(From randomization until data cut-off (15 July 2014); Up to 1031 days)
- Overall Survival(From randomization until data cut-off (15 July 2014); Up to 1031 days)