A Randomized, Placebo-controlled Phase II Study to Compare the Efficacy and Safety of SU011248 Versus Placebo in Patients With Advanced Urothelial Transitional Cell Carcinoma Who Have Failed or Are Intolerant to Cisplatin-based Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 5
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of this study is to find out if SU011248 works and if it is safe in patients with advanced transitional cell carcinoma.
详细描述
The study objectives include the determination of the antitumor effect of SU011248 in patients with urothelial transitional cell carcinoma and to also determine the toxicities and tolerability of SU011248 in patients with urothelial transitional cell carcinoma who have failed or are intolerant to cisplatin-based chemotherapy.
The primary endpoint of the study is to compare progression free survival at 4 months in patients who received SU011248 plus BSC versus patients who received placebo plus BSC
The secondary endpoint is to compare the objective response rate and duration of response in patients who received SU011248 plus BSC versus patients who received placebo plus BSC, to describe the QOL and safety profile of SU011248 when compared to placebo and to describe the overall survival in patients who received SU011248 plus BSC versus patients who received placebo plus BSC
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
- Single (Participant)
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/cytologically proven inoperable, metastatic or recurrent transitional cell carcinoma of the urothelial tract
- •Mixed histology with predominant TCC allowed.
- •Failed, intolerant or ineligible for cisplatin based chemo
- •Measurable Disease (RECIST)Not previously irradiated.
- •Recovered from previous acute treatment to grade 1(CTCAE Vers. 3.0)
- •No weight loss >/- 10% within 28 days of day 0
- •Adequate Organ Function
排除标准
- •Adenocarcinoma, squamous carcinoma or other histology without any components of transitional carcinoma.
- •Small cell histology
- •More than one previous systemic chemo
- •Excised metastases without remaining measureable disease
- •Prior therapy with angiogenesis inhibitors
研究组 & 干预措施
Arm 1
SU011248 - 4 weeks on followed by 2 weeks rest period every 6 weeks
干预措施: SU011248 (Drug)
Arm 2
1 50 mg capsule OD PO for 4 weeks with 2 week rest until disease progression. Any patient with disease progression will be unblinded and patients on the placebo arm may then be considered for the open label Sutent treatment.
干预措施: Placebo (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 4 months
次要结局
- Change in health-related quality of life(Study Duration)
- Number of participants that develop an adverse event to treatment.(Study Duration)
- Overall Survival(Study Duration)
- objective response rate(Study Duration)
- duration of response(study duration)
研究者
Tina Cheng
Principal Investigator
AHS Cancer Control Alberta