EUCTR2017-004166-10-IT进行中（未招募）1 期
A Phase 2, Open-label Study of Rucaparib in Patients with Locally Advanced or Metastatic Urothelial Carcinoma - ATLAS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 97
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Have histologically or cytologically confirmed locally advanced unresectable or metastatic transitional cell carcinoma of the urothelium (renal pelvis, ureter, urinary bladder or urethra)
- •Received 1 or 2 prior treatment standard of care regimens for advanced unresectable or metastatic disease
- •Confirmed radiologic disease progression during or following recent treatment
- •Mandatory biopsy is required during screening
- •Measurable disease per RECIST v1.1
- •Adequate organ function
- •ECOG 0 or 1
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •Prior treatment with a PARP inhibitor
- •Symptomatic and/or untreated CNS metastases
- •Duodenal stent and/or any gastrointestinal disorder that may interfere with absorption of rucaparib
研究者
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