NCT01335269已完成1 期
An Open Label Phase I Dose Finding Study of BI 853520 Administered Orally in a Continuous Dosing Schedule in Patients With Various Advanced or Metastatic Non-hematologic Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 5
- 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 in the dose finding phase
研究概览
简要总结
The primary objective of this trial is to determine the safety and tolerability of BI 853520 monotherapy by defining the maximum tolerated dose (MTD) and recommending the dose for further trials in the development of this compound.
Secondary objectives are
- determination of the pharmacokinetic (PK) profile;
- exploratory pharmacodynamic analysis; and
- 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
- 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
Treatment arm
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 in the dose finding phase
时间窗: After the first 28 days of treatment
次要结局
- AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose)(up to 48 hours)
- Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) after the last dose in cycle 1(up to 24 hours)
- AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) after the last dose in cycle 1(up to 24 hours)
- Disease control rate (CR or PR or SD per RECIST v1.1) )(up to 39 months)
- Duration of disease control (measured from drug start date to the date of disease progression for patients who had CR or PR or SD during treatment)(up to 39 months)
- Objective response rate (CR or PR per RECIST v1.1)(up to 39 months)
- Tumour shrinkage (in millimetre) defined as change from baseline to the minimum post-baseline sum of diameters of target lesions.(up to 39 months)
- Pharmacodynamic assessment: phosphorylated and total PTK2 (FAK) modulation in tumour biopsies(baseline, day 22 and day 28)
- Cmax (maximum measured concentration of the analyte in plasma) after first dose(up to 48 hours)
研究者
研究点 (5)
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