NCT00683306Approved For Marketing不适用
Multicentre, Open Label, Extension Study of Treatment With Gefitinib(IRESSA™) for Patients Completing Other Gefitinib Clinical Studies Who May Benefit From Gefitinib Treatment
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
- 发起方
- AstraZeneca
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to provide gefitinib treatment to patients who, on completion or closure of other gefitinib clinical studies, were either receiving placebo treatment, or are continuing on the same dose and regimen of gefitinib established in their preceding study, for as long as the patients continue to derive benefit.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have completed preceding gefitinib therapy from either the 1839IL/0709 (250mg dosing) study or 1839IL/0710 (250mg dosing) study and in the opinion of the investigator may benefit from further gefitinib treatment.
- •No more than 14 days lapse in gefitinib treatment between the patient completing the preceding gefitinib clinical study and beginning of this study except when agreed by the AstraZeneca physician.
排除标准
- •Any evidence of clinically active interstitial lung disease (patients with chronic,stable, radiographic changes who are asymptomatic need not be excluded).
- •In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).
- •Withdrawal, at any time, from the preceding gefitinib study.
- •Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort
研究者
研究点 (1)
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