A Phase 2, Open-label Study of Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 97
- 试验地点
- 64
- 主要终点
- Objective Response Rate (ORR) Per RECIST Version 1.1
研究概览
简要总结
The purpose of the ATLAS study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •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 advanced 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
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
研究组 & 干预措施
Rucaparib
Oral rucaparib (monotherapy)
干预措施: Rucaparib (Drug)
结局指标
主要结局
Objective Response Rate (ORR) Per RECIST Version 1.1
时间窗: Time from first dose to date of progression, up to approximately 19 months
ORR is defined as the proportion of patients with a confirmed response of complete response (CR) or partial response (PR) by RECIST v1.1 as assessed by the investigator. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR), is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
次要结局
- Overall Survival(The total study time for reporting of deaths was approximately 19 months.)
- Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator(Cycle 1 Day 1 to End of Treatment, up to approximately 10 months)
- Pharmacokinetics - Trough (Cmin) Level Rucaparib Concentrations(From Cycle 2 Day 1 to Cycle 4 Day 1, or approximately 2 months)