NCT00246974已完成2 期
An Open Randomised Phase II Study Of Gemcitabine Plus Cisplatin +/- Concomitant or Sequential ZD1839 in Patients With Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium
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
- 125
- 试验地点
- 1
- 主要终点
- Time to progression (TTP)
研究概览
简要总结
The primary objective of the study is to assess the activity of ZD1839 250 mg once daily in addition to the standard chemotherapy in patients with advanced or metastatic transitional cell carcinoma of the urothelium by estimating the time to progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically or cytologically-confirmed transitional cell carcinoma of the urothelium
- •Locally advanced or metastatic disease
- •At least one measurable lesion as defined by RECIST
- •Chemotherapy-naiv
排除标准
- •Previous chemotherapy or other systemic antitumour therapy
- •Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma, cervical cancer in situ or locally limited prostate cancer
研究组 & 干预措施
1
Active Comparator
Cisplatin + Gemcitabin
干预措施: Gemcitabine (Drug)
1
Active Comparator
Cisplatin + Gemcitabin
干预措施: Cisplatin (Drug)
2
Experimental
Cisplatin + Gemcitabin + Gefitinib
干预措施: Gemcitabine (Drug)
2
Experimental
Cisplatin + Gemcitabin + Gefitinib
干预措施: Cisplatin (Drug)
2
Experimental
Cisplatin + Gemcitabin + Gefitinib
干预措施: Gefitinib (Drug)
结局指标
主要结局
Time to progression (TTP)
次要结局
- 6. Safety and tolerability
- 1. Response rate
- 2. Overall survival time
- 3. Time to treatment failure
- 4. Disease control rate
- 5. Duration of response
研究者
研究点 (1)
Loading locations...
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