NCT00621361已完成1 期
A Phase I, Multi-Centre, Open-Label, Dose Selection Study to Assess the Safety and Tolerability of Cediranib (RECENTIN™, AZD2171) in Combination With Etoposide and Cisplatin (EP) as First Line Therapy for Lung Cancer Patients With Extensive Stage or Metastatic Disease for Whom EP Would be a Standard Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Assess the safety and tolerability of Cediranib (RECENTIN™, AZD2171) in combination with etoposide and cisplatin (EP).
研究概览
简要总结
This study is to assess the safety and tolerability of Cediranib (RECENTIN™, AZD2171)in combination with etoposide and cisplatin (EP) as first line treatment for lung cancer patients with extensive stage or metastatic disease for whom EP would be a standard therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer diagnosis and stage (histological or cytological confirmed extensive stage lung cancer, which EP would be considered a standard therapy, required at the time of diagnosis.)
- •No prior chemotherapy or immunotherapy for advanced stage lung cancer (prior radiotherapy will be permitted if it is outside of the measurable field and greater than or equal to 2 weeks prior to entry to the study.)
- •WHO performance status 0-2
排除标准
- •Untreated unstable brain or meningeal metastases
- •Patient with inappropriate laboratory tests values
- •Inadequate bone marrow reserve.
研究组 & 干预措施
2
Active Comparator
Etoposide + Cisplatin
干预措施: Cisplatin (Drug)
1
Experimental
干预措施: AZD2171 (Drug)
2
Active Comparator
Etoposide + Cisplatin
干预措施: Etoposide (Drug)
结局指标
主要结局
Assess the safety and tolerability of Cediranib (RECENTIN™, AZD2171) in combination with etoposide and cisplatin (EP).
时间窗: From date of consent through to data cut-off, 7th August 2009.
次要结局
- Preliminary efficacy assessment of Cediranib in combination with etoposide & cisplatin using available tumor assessment data to assess response rate,duration of response,change in tumor size(only those with measurable disease)& progression free survival(From date of randomisation through to data cut-off, 7th August 2009.)
研究者
研究点 (1)
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