A Phase Ib Open Label Study to Assess the Safety, Tolerability and Pharmacokinetics of Continuous Dosing With BIBW 2992 Combined With Two Different Regimens of Backbone Chemotherapy: Cisplatin Combined With 5 Fluorouracil and Cisplatin Combined With Paclitaxel in Patients With Advanced Solid Tumors.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 3
- 主要终点
- Number of Participants With Dose Limiting Toxicities (DLT) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)
研究概览
简要总结
Study to determine the maximum tolerated dose of BIBW 2992 when combined with backbone chemotherapies consisting in cisplatin plus paclitaxel or cisplatin plus 5 FU.
The overall safety, the pharmacokinetics and the anti-tumour efficacy will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
A. BIBW 2992-cisplatin-paclitaxel
daily oral dose of BIBW 2992 combined with 3-weekly infusion of cisplatin-paclitaxel
干预措施: BIBW 2992 (Drug)
B. BIBW 2992-cisplatin-5FU
daily oral dose of BIBW 2992 combined with 3-weekly infusion of cisplatin-5FU
干预措施: BIBW 2992 (Drug)
结局指标
主要结局
Number of Participants With Dose Limiting Toxicities (DLT) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)
时间窗: 21 days
Number of participants with DLT in the first cycle (21 days) for the determination of the MTD.
Maximum Tolerated Dose (MTD) for Regimen A and Regimen B
时间窗: 21 days
The MTD was determined using a standard 3 +3 dose escalation cohort design. The sample size and the number of patients who receive each dose in this design depends on the frequency of DLT at each dose level in cycle 1.
次要结局
- Number of Patients With Objective Response(Tumor assessment were performed at screening and every 2nd cycle until end of follow up (=end of treatment + 30 days +/- 7 days))
- Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss)(0.05hours (h) before administration and 1h, 2h, 2h 55 minutes (min), 4h, 4h 30min, 5h, 6h, 8h, 10h, 24h, 48h, 216h, 480h after administration)