NCT03330886已完成不适用
An Observational Study of the Safety of Atezolizumab in Patients With Advanced or Metastatic Urothelial Carcinoma in Argentina
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Percentage of Participants with Adverse Events (AE)
研究概览
简要总结
The main purpose is to study the safety and effectiveness of atezolizumab in patients with locally advanced or metastatic urothelial carcinoma whose disease has worsened during or following platinum-containing chemotherapy, or within 12 months of receiving platinum-containing chemotherapy, either before (neoadjuvant) or after (adjuvant) surgical treatment in common clinical practice settings in Argentina.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed an informed consent form submitted to the Administración Nacional de Medicamentos Alimentos y Tecnología Médica (ANMAT)
- •Histologically or cytologically documented locally advanced or metastatic urothelial carcinoma (including renal pelvis, ureters, urinary bladder, and urethra).
- •Have received at least one dose of atezolizumab as per local label and clinical practice.
排除标准
- •Contraindicated atezolizumab therapy
结局指标
主要结局
Percentage of Participants with Adverse Events (AE)
时间窗: Up to approximately 2 years.
次要结局
- Overall Survival (OS)(Up to approximately 2 years.)
- Percentage of participants with Confirmed Objective Response (ORR) of Complete Response (CR) or Partial Response (PR)(Up to approximately 2 years.)
- Duration of Response (DOR)(Up to approximately 2 years.)
- Progression Free Survival (PFS)(Up to approximately 2 years.)
研究者
研究点 (1)
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