NCT02747953已完成2 期
An Open Label Compassionate Use Programme of Gilotrif (Afatinib) in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- response rate
研究概览
简要总结
The program will provide early access to the investigational drug gilotrif in patients with advanced non-small cell lung cancer who have failed at least 6 months on erlotinib or gefitinib.
The Compassionate Use Programme will also provide additional safety information on gilotrif use.
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
- •Patients with pathologically confirmed diagnosis of adenocarcinoma of the lung Stage IV with progressive disease following at least one line of platinum-based cytotoxic chemotherapy
- •Patients progressing after clinical benefit on erlotinib or gefitinib: clinical benefit is defined as stable disease for at least 6 months, or a complete or partial response, or the presence of an activating mutation of the epidermal growth factor (EGF) receptor family.
- •No further treatment option is available.
- •Male and female patients age ≥18 years.
- •Written informed consent that is consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines and local law.
排除标准
- •Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom.
- •Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator, would compromise patient safety.
- •History of cardiac disease that is clinically significant, as judged by the investigator or uncontrolled cardiac disease (including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3).
- •Aspartate amino transferase (AST) or alanine amino transferase (ALT) ≥ three times the upper limit of normal (if related to liver metastases ≥ five times the upper limit of normal).
- •Bilirubin ≥1.5 mg/dl
- •Serum creatinine ≥ 1.5 times of the upper normal limit or calculated/measured creatine clearance ≤ 45ml/min
- •Women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the treatment.
- •Pregnancy or breast feeding.
- •Pre-existing Interstitial Lung Disease (ILD).
- •Patients suitable to be included into afatinib clinical trials
研究组 & 干预措施
afatinib
Experimental
干预措施: Gilotrif (Drug)
结局指标
主要结局
response rate
时间窗: 6 months
次要结局
未报告次要终点
研究者
Keunchil Park
Professor
Samsung Medical Center
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