NCT00344773已完成2 期
An Open-label, Multi-centre Study to Evaluate Efficacy and Safety of Gefitinib as the First-line Treatment for Locally Advanced (IIIB), Metastatic (IV) or Recurrent Pulmonary Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.
研究概览
简要总结
The purpose of this study is to evaluate the overall objective tumor response rate (ORR) of Gefitinib.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients require histological biopsy and paraffin block more than 5mg from the original tumour or metastatic site to perform EGFR mutational analysis
- •WHO Performance Status 0-2
- •No prior chemotherapy, biological or immunological therapy/surgery
排除标准
- •Any evidence of clinically active interstitial lung disease
- •Newly diagnosed CNS metastases that have not yet been definitively treated with surgery /radiation
- •Patients with previously diagnosed and treated CNS metastases or spinal cord compression
研究组 & 干预措施
Gefitinib
Experimental
Gefitinib 250mg tablet once daily
干预措施: Gefitinib (Drug)
结局指标
主要结局
Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.
时间窗: baseline to 12 months
Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients. RECIST criteria: CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diameter of target lesions PD = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet above criteria
次要结局
- Progression Free Survival (PFS)(baseline to 4 months)
- Safety Profile: Participants With Adverse Events(baseline to end of study)
- Overall Survival (OS)(baseline to 12 months)
研究者
研究点 (1)
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