NCT00748709终止2 期
An Open Label Phase II Trial of BIBW 2992 (Afatinib) in Genetically Pre-screened Cancers With EGFR and/or HER2 Gene Amplification or EFGR Activating Mutations.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 15
- 主要终点
- Percentage of Participants With Objective Response (OR)
研究概览
简要总结
This is a Phase II open-label exploratory trial of BIBW 2992 administered to patients with tumors of various histologies found to possess EGFR and/or HER2 gene amplification, or EGFR activating mutations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 99 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
BIBW 2992 (Afatinib)
Experimental
BIBW 2992 (Afatinib) for patients FISH positive for/or harboring EGFR or HER2 Mutation
干预措施: BIBW 2992 (Afatinib) (Drug)
结局指标
主要结局
Percentage of Participants With Objective Response (OR)
时间窗: Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks thereafter
OR is defined as the percentage of patients with complete response (CR) or partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST 1.0).
次要结局
- Duration of OR(Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock.)
- Time to Objective Response (OR)(Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock)
- Progression-free Survival (PFS)(Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock.)
- Percentage of Participants With Clinical Benefit (CB)(Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock)
- Patients With AEs Resulting in Dose Reduction or Treatment Discontinuation(First administration of trial medication until 28 days after last administration of trial medication)
- Maximum CTCAE Grade(First administration of trial medication until 28 days after last administration of trial medication)
- Number of Patients With Diarrhea or Rash(First administration of trial medication until 28 days after last administration of trial medication)
- Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 15 (Cpre,ss,15) for Patients on 50mg on Day 15(Day 15)
研究者
研究点 (15)
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