NCT01214616已完成1 期
An Open-label Phase I Study of Once Daily Oral Treatment With BIBW 2992 in Combination With Weekly Vinorelbine Intravenous Injection in Japanese Patients With Advanced Solid Tumours
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
- 17
- 试验地点
- 4
- 主要终点
- Number of Patients With Dose Limiting Toxicities (DLTs) During 1st Course
研究概览
简要总结
- To identify the Maximum Tolerated Dose (MTD) of afatinib in combination with vinorelbine i.v. by assessment of Dose Limiting Toxicities (DLT);
- To assess safety and anti-tumour efficacy and determine pharmacokinetic characteristics of afatinib and vinorelbine i.v.
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 74 Years（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
afatinib and vinorelbine IV
Experimental
patient to receive 20mg or 40mg of po daily afatinib in combination with vinorelbine IV
干预措施: afatinib 20mg (Drug)
afatinib and vinorelbine IV
Experimental
patient to receive 20mg or 40mg of po daily afatinib in combination with vinorelbine IV
干预措施: afatinib 40mg (Drug)
afatinib and vinorelbine IV
Experimental
patient to receive 20mg or 40mg of po daily afatinib in combination with vinorelbine IV
干预措施: vinorelbine IV 25 or 20mg/m2 (Drug)
结局指标
主要结局
Number of Patients With Dose Limiting Toxicities (DLTs) During 1st Course
时间窗: during 1st course
DLTs and Maximum Tolerated Dose (MTD) of afatinib in combination with vinorelbine iv. (MTD = not determined)
Drug-related Adverse Events
时间窗: during the treatment period or up to 28 days after the completion of drug administration, up to 730 days
Number of patients with drug-related adverse events
次要结局
- AUCτ,ss for Afatinib(pre-dose, 1, 2, 3, 4, 6, 7hours, and 23hours55minutes after 7th or 14th or 21th dose (as "with Vinorelbine") and 20th dose (as "without Vinorelbine"))
- Objective Tumour Response(Pre-treatment, every 8 weeks after start of study treatment, end of treatment)
- Cmax for Vinorelbine(predose, 10minutes, 0.5, 1, 4, 7 hours, 23hours55minutes after 2nd or 3rd or 4th dose (as "with afatinib") and 1st dose (as "without afatinib"))
- Cmax,ss for Afatinib(pre-dose, 1, 2, 3, 4, 6, 7hours, and 23hours55minutes after 7th or 14th or 21th dose (as "with Vinorelbine") and 20th dose (as "without Vinorelbine"))
- AUC0-∞ for Vinorelbine(predose, 10minutes, 0.5, 1, 4, 7 hours, 23hours55minutes after 2nd or 3rd or 4th dose (as "with afatinib") and 1st dose (as "without afatinib"))
研究者
研究点 (4)
Loading locations...
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