NCT02695290终止4 期
An Open-label, Single-arm Phase IV Study of Afatinib in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer Who Have Poor Performance Status and Whose Tumors Have the Common Epidermal Growth Factor Receptor (EGFR) Mutations, Exon 19 Deletions or Exon 21(L858R) Substitution Mutations
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Percentage of Patients With Occurrence of Adverse Events (AEs) Leading to Dose Reduction of Afatinib
研究概览
简要总结
There is a medical need for improving treatment of poor performance status patients with EGFR driver mutations and documenting safety and tolerability of existing agents.
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
Afatinib
Experimental
干预措施: Afatinib (Drug)
结局指标
主要结局
Percentage of Patients With Occurrence of Adverse Events (AEs) Leading to Dose Reduction of Afatinib
时间窗: Up to 98 days
Percentage of patients with occurrence of Adverse Events (AEs) leading to dose reduction of afatinib.
次要结局
- Percentage of Patients With Occurrence of CTCAE Grade 3 or Higher Diarrhoea, Rash/Acne+, Stomatitis+ and Paronychia+ (+ Represents Grouped Term)(Up to 98 days)
- Time to First Dose Reduction of Afatinib Caused by Adverse Events (AEs)(Up to 98 days)
研究者
研究点 (1)
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