NCT02278978Unknown2 期
A Phase II Trial of BIBF1120 in Patients With Advanced FGFR3 Mutated, FGFR3 Overexpressed, or FGFR3 Wild Type Urothelial Carcinoma of Urinary Bladder, Urethra, Ureter, and Renal Pelvis and Who Have Failed Platinum-based Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Response rate assessed by RECEST version 1.1
研究概览
简要总结
BIBF1120 in patients with advanced FGFR3 mutated, FGFR3 overexpressed, or FGFR3 wild type urothelial carcinoma of urinary bladder, urethra, ureter, and renal pelvis and who have failed platinum-based chemotherapy.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological confirmation of urothelial carcinoma , with metastatic disease
- •Measurable disease
- •Previously treated with platinum-based chemotherapy administered
排除标准
- •Radiographic evidence of cavitary or necrotic tumours
- •Active brain metastasis.Leptomeningeal metastasis
- •Chemotherapy, radiotherapy, targeted therapy with monoclonal antibodies or small tyrosine kinase inhibitors
- •Grade 1 treatment-related toxicity from previous chemotherapy, radiotherapy, or targeted therapy
- •Prior treatment with BIBF 1120 or other VEGFR inhibitors
- •Significant cardiovascular diseases:
- •Pericardial effusion
- •Significant bleeding or thrombosis
- •Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
- •Major injuries within the past 10 days with incomplete wound healing and/or planned surgery during the on-treatment study period
研究组 & 干预措施
FGFR3 mutated
Experimental
BIBF 1120 in patients with advanced FGFR3 mutated
干预措施: BIBF1120 (Drug)
FGFR3 overexpressed
Experimental
BIBF 1120 in patients with advanced FGFR3 overexpressed
干预措施: BIBF1120 (Drug)
FGFR3 wild type
Experimental
BIBF 1120 in patients with advanced FGFR3 wild type
干预措施: BIBF1120 (Drug)
结局指标
主要结局
Response rate assessed by RECEST version 1.1
时间窗: 2 months
To define the response rate of BIBF1120 in patients with advanced FGFR3-mutated,overexpressed,wild type UC and who have failed platinum-based chemotherapy.
次要结局
未报告次要终点
研究者
研究点 (1)
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