NCT01118039Unknown2 期
A Phase II Study Assessing SU-011248 in Previously Untreated Patients With Advanced Urothelial Cancer Ineligible for Cisplatin-Based Chemotherapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 41
- 试验地点
- 8
- 主要终点
- Time to disease progression
研究概览
简要总结
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying the side effects of giving sunitinib malate and to see how well it works in treating patients with locally recurrent, locally advanced, unresectable, or metastatic urinary tract cancer.
详细描述
OBJECTIVES:
Primary
- To determine the time to disease progression (defined as the time from diagnosis of metastatic urothelial carcinoma until first confirmed progression of the disease) in patients with locally recurrent, locally advanced, unresectable, or metastatic urothelial cancer treated with sunitinib malate and ineligible for cisplatin-based chemotherapy.
- To determine the safety of this drug in these patients.
Secondary
- To determine the progression-free survival of patients treated with this drug.
- To determine the overall response rate in patients treated with this drug.
- To determine the overall survival of patients treated with this drug.
- To determine the time to treatment failure in patients treated with this drug.
- To determine the pharmacodynamic profile of this drug in pre- and post-treatment serum and tumor tissue (i.e., IL8, VEGF, MMP9, bFGF, p27, Ki-67, and apoptosis [H/E]) at week 6, and if possible, at time of progression.
- To determine the quality of life of patients treated with this drug using the QLQ-C30 version 3 questionnaire.
研究设计
- 研究类型
- Interventional
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Time to disease progression
Safety
次要结局
- Progression-free survival
- Overall response rate
- Overall survival
- Time to treatment failure
- Pharmacodynamic profile
- Quality of life
研究者
研究点 (8)
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