EUCTR2017-004166-10-DE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
相关药物
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 regimens for locally advanced unresectable or metastatic disease and c onfirmed radiologic disease progression during or following recent treatment. The principal investigator is
- •responsible for ensuring the patient has received standard of care treatment as appropriate in the country of enrollment, taking into account the patient’s current health status as well as how they responded to/tolerated prior treatment(s).
- •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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