NCT00790426已完成2 期
A Phase II Multi-center, Non-randomized, Open Label Study of TKI258 in FGFR3 Mutated and FGFR3 Wild Type Advanced Urothelial Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 9
- 主要终点
- Overall response rate
研究概览
简要总结
This study will evaluate the efficacy of TKI258 in patients with advanced urothelial cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients with transitional cell cancer of the bladder, urethra, ureter, or renal pelvis
- •Patients who have archival tumor tissue available for FGFR3 mutational status screening
- •Patients with progressive disease
- •Patients with measurable disease by RECIST
- •Patients previously treated with at least 1 but not more than 3 systemic cytotoxic regimens with at least one of these regimens including at least one of the following: cisplatin, carboplatin, gemcitabine or taxane administered in the perioperative or advanced setting
- •Age ≥ 18 years
- •WHO Performance Status ≤ 2
- •Patients willing and able to take oral medication, follow scheduled visits, treatment plan and laboratory tests
- •Patients with signed and witnessed informed consent form
- •Patients with adequate organ function
排除标准
- •Patients with brain cancer
- •Patients with other cancers except for certain skin, cervical & prostate cancers
- •Patients who have not recovered from previous cancer treatment
- •Patients who have severe and/or uncontrolled medical conditions which could affect participation in the study
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
FGFR3 wild type
Experimental
干预措施: TKI258 (Drug)
FGFR3 mutant
Experimental
干预措施: TKI258 (Drug)
结局指标
主要结局
Overall response rate
时间窗: 4 months
次要结局
- Progression free survival(4 Months)
- Disease control rate(4 Months)
- overall survival(4 Months)
研究者
研究点 (9)
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