A Non-interventional Retrospective Study to Describe Early Clinical Experience With Cabozantinib in Patients With Advanced Renal Cell Carcinoma in the United Kingdom (UK)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 108
- 试验地点
- 6
- 主要终点
- Distribution of cabozantinib starting dose.
研究概览
简要总结
Clinical experience with cabozantinib is limited in the UK and Ireland and there is anecdotal evidence of there being variability between clinicians in terms of where cabozantinib is used in the treatment pathway. The present study aims to collate and report the experiences of a sample of National Health Service (NHS) Trusts that enrolled patients onto the managed access programme. The study will describe the positioning of cabozantinib in the treatment pathway, associated clinical outcomes and characteristics of patients with advanced RCC receiving cabozantinib in this early clinical experience setting. The results will provide valuable information for collective learning on how to prescribe and manage cabozantinib and its optimal positioning in the patient pathway. Overall, the findings will contribute to a better understanding of how best to manage patients with advanced RCC in routine practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •A diagnosis of advanced RCC
- •Prescribed cabozantinib as part of the Managed Access Programme (MAP) (alive or deceased at study data collection)
- •Aged ≥18 years at start of cabozantinib treatment.
排除标准
- •Decline or lack the capacity to consent for researcher access to their medical records (if living)
- •Hospital medical records are unavailable for review
结局指标
主要结局
Distribution of cabozantinib starting dose.
时间窗: Baseline
Distribution, mean (SD) and median (quartiles) cabozantinib starting dose.
Distribution of reasons for dose modifications.
时间窗: 24 months
Median time to first dose modification
时间窗: 24 months
Positioning of cabozantinib in the treatment pathway
时间窗: 24 months
Positioning of cabozantinib in the treatment pathway (second line, third line, fourth line or above)
Daily dose during treatment
时间窗: 24 months
Mean (SD) and median (quartiles) cabozantinib daily dose during treatment.
Proportion of patients with dose modifications
时间窗: 24 months
Proportion of patients with dose modifications and mean (SD) and median (quartiles) number of dose modifications per patient.
Proportion of patients permanently discontinuing cabozantinib.
时间窗: 24 months
Distribution of reasons for discontinuation of treatment
时间窗: 24 months
Median duration of cabozantinib treatment (months)
时间窗: 24 months
Distribution of relevant concomitant treatments
时间窗: 24 months
Radiation procedures, denosumab, bisphosphonates.
Distribution of systemic therapies prescribed for advanced RCC after discontinuation of cabozantinib.
时间窗: 24 months
次要结局
- Progression Free Survival (PFS)(3, 6, 9, 12, 18 and 24 months and median PFS.)
- Overall Survival (OS)(6, 12, 18 and 24 months)
- Distribution of RCC stage and histological type at initial RCC diagnosis(baseline)
- Distribution of metastatic sites.(baseline)
- Distribution of International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk group(baseline)
- Time (months) from advanced RCC diagnosis to cabozantinib initiation.(baseline)
- Distribution of RCC stage at cabozantinib initiation.(baseline)
- Objective Response Rate (ORR)(3, 6, 9 and 12 months)