NCT01801137已完成2 期
A Multicentre Phase III Trial to Determine the Efficacy of RAD 001 (Everolimus, Afinitor) as Second Line Therapy in Patients With Transitional Cell Carcinoma TCC of the Urothelium Which Failed or Progressed After First Line Chemotherapy
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
- Hopital Foch
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Progression-free survival rate at 12 weeks
研究概览
简要总结
A study to determine the efficacy of Everolimus(Afinitor®) as third line therapy in patients with transitional cell carcinoma of the urothelium which failed or progressed after two lines of chemotherapy
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
- •Provision of written informed consent
- •Male or female aged more than 18 years
- •Histologically proven transitional cell carcinoma of the urothelium
- •Metastatic or locally advanced disease not amenable to curative surgery and/or radiotherapy
- •Recurrence or progression after at least one chemotherapy regimen and for unresectable/advanced disease
- •No more than 2 lines of previous chemotherapy..
- •Measurable disease (RECIST criteria)
- •Previously irradiated lesions are not considered measurable- ECOG performance status of 0, 1 or 2
排除标准
- •No prior treatment with anti cancer agents, including radiotherapy, in the last 4 weeks.
- •No currently active CNS involvement
- •No pregnancy. Women of child bearing potential must have a negative pregnancy test.
- •No uncontrolled diabetes
- •No symptomatic coronary artery disease, myocardial infarction within the last six months, congestive cardiac failure greater than New York Heart Association (NYHA) class II, uncontrolled or symptomatic cardiac arrhythmia
研究组 & 干预措施
Afinitor
Experimental
Treatment by Afinitor 10 mg per day
干预措施: Everolimus (Afinitor®) (Drug)
结局指标
主要结局
Progression-free survival rate at 12 weeks
时间窗: 3 months
If a patient has not had an event, Progression-free survival is censored at the date of last adequate tumor assessment.
次要结局
未报告次要终点
研究者
研究点 (1)
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