NCT01905111已完成1 期
An Open-label Phase I Dose Finding Study of BI 853520 Administered Orally in a Continuous Dosing Schedule in Japanese and Taiwanese Patients With Various Advanced or Metastatic Solid Tumours
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Determination of the MTD. It will be defined by the occurrence of dose-limiting toxicities (DLT) during the first treatment cycle of each patient
研究概览
简要总结
The primary objective of this trial is to explore the safety and tolerability of BI 853520 monotherapy and determine the maximum tolerated dose (MTD) for Japanese and Taiwanese patients with advanced or metastatic solid tumours.
Secondary objective is collection of preliminary data on anti-tumour efficacy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 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
BI 853520
Experimental
BI 853520 once daily in a dose escalation schedule
干预措施: BI 853520 (Drug)
结局指标
主要结局
Determination of the MTD. It will be defined by the occurrence of dose-limiting toxicities (DLT) during the first treatment cycle of each patient
时间窗: After the first 28 days of treatment
次要结局
- Objective response rate(Every 8 weeks until end of study participation, assessed up to 12 months)
- Disease control rate(Every 8 weeks until end of study participation, assessed up to 12 months)
- Duration of disease control(Every 8 weeks until end of study participation, assessed up to 12 months)
- Tumour shrinkage (in millimetre) defined as the difference between the minimum post-baseline sum of longest diameters of target lesions and the baseline sum of longest diameters of the same set of target lesions(Every 8 weeks until end of study participation, assessed up to 12 months)
研究者
研究点 (2)
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