NCT04416646已完成不适用
Cabozantinib in the Elderly With Metastatic Renal Cell Carcinoma: Observational Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical tolerability of Cabozantinib
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Cabozantinib in the treatment of patients with renal cell carcinoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 70 years
- •Histological diagnosis of Renal Cell Carcinoma (any histology, with the exclusion of urothelial carcinomas)
- •Locally advanced disease or metastatic disease (any site, measurable or non- measurable lesions), progressing after at least one line of VEGFR-targeted therapy (as per official registration of the drug at AIFA, in case of extension to first-line treatment, TKI-naïve patients will also be eligible), with or without previous exposure to check-point inhibitors.
- •Life expectancy of at least 3 months
- •Adequate hepatic, renal and bone marrow function as judged by the treating oncologist.
- •Written informed consent
排除标准
- •Inability to swallow cabozantinib tablets
- •Serious comorbidities or cognitive impairment, which may interfere with cabozantinib administration and/or patient's follow up, as judged by the treating physician
- •Absence of a reliable caregiver, as judged by the treating physician
结局指标
主要结局
Clinical tolerability of Cabozantinib
时间窗: Average of 1 year
the main purpose is to register the Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\]
次要结局
- Description of response rate of patients treated with Cabozantinib.(From date of randomization until the date of last documented, assessed up to 18 months")
研究者
Umberto basso
Doctor of Medicine I level
Istituto Oncologico Veneto IRCCS
研究点 (1)
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