NCT03419572已完成不适用
Prospective Non Interventional Study of Cabozantinib Tablets in Adults With Advanced Renal Cell Carcinoma Following Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 689
- 试验地点
- 91
- 主要终点
- The proportion of subjects with dose modifications due to AEs
研究概览
简要总结
The objective of this study is to understand the utilization of cabozantinib in subjects with advanced renal cell carcinoma (RCC) following prior VEGF-targeted therapy in real life settings in terms of dose modifications due to adverse events (AEs) when used as a second line therapy or third and later line therapy. Other patterns of use of cabozantinib will also be described.
详细描述
The study will follow the real-life management of patients in clinical practice. Visits will take place according to the study site's clinical practice. Cabozantinib is to be administered as directed by the investigator according to the study site's usual clinical practice and the Cabometyx™ Summary of Product Characteristics (SmPC).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old
- •Has a diagnosis of advanced RCC
- •Has received at least one prior VEGF-targeted therapy
- •For whom the treating physician has decided to start treatment with cabozantinib tablets prior to inclusion
- •No previous exposure to cabozantinib prior to inclusion
- •Not concurrently involved in an interventional study
- •Consents to participate in this noninterventional study
排除标准
- •There are no exclusion criteria for this study.
结局指标
主要结局
The proportion of subjects with dose modifications due to AEs
时间窗: 12 months
次要结局
- Proportion of subjects with concomitant radiotherapies(12 months)
- Overall best response(12 months)
- Description of cabozantinib dose intensity (average daily dose compared to starting dose)(12 months)
- Health care resource utilisation: number of visits to health care professionals (hospitalisation, surgical procedure, emergency room, physician, homecare by nurse) associated with the management of treatment-related AEs(12 months)
- Description of number of cabozantinib dose modifications (any modification, reduction, temporary interruption, increase or discontinuation)(12 months)
- Description of cabozantinib starting dose (combination of dose per intake and frequency)(12 months)
- Description of daily dose of cabozantinib received(12 months)
- Duration of cabozantinib treatment (expressed as mean and median time to end of treatment)(12 months)
- Median Progression Free Survival (PFS) time(12 months)
- Reason for cabozantinib dose modification (any modification, reduction, temporary interruption or discontinuation)(12 months)
- Median time to first cabozantinib dose modification (any modification, reduction, temporary interruption, increase or discontinuation) due to AEs and for any reason(12 months)
- Description of systemic therapy (drug name) planned following cabozantinib discontinuation(12 months)
- Overall Survival (OS) rate at the end of the study(12 months)
- Health care resource utilisation: Description of number of unplanned laboratory tests associated with the management of treatment-related AEs(12 months)
- Health care resource utilisation: Description of concomitant medications (by drug class and preferred name) associated with the management of treatment-related AEs(12 months)
研究者
研究点 (91)
Loading locations...
相似试验
进行中（未招募）
不适用
Study of Cabozantinib as Monotherapy or in Combination With Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma Under Real-life Clinical Setting in 1st Line Treatment.Advanced Renal Cell CarcinomaMetastatic Renal Cell CarcinomaNCT03647878Ipsen224
招募中
2 期
Cabozantinib in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer and Those With Other Genotypes: ROS1 or NTRK Fusions or Increased MET or AXL ActivityNon-Small Cell Lung CancerNCT01639508Memorial Sloan Kettering Cancer Center86
进行中（未招募）
3 期
A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted TherapyDifferentiated Thyroid CancerNCT03690388Exelixis187
进行中（未招募）
1 期
Study of cabozantinib in metastatic renal carcinoma in aged fragile patientsEUCTR2019-001639-30-ESSpanish Oncology Genitourinary Group - SOGUG50
终止
1 期
Cabozantinib in Patients With Advanced Hepatocellular Carcinoma With Child Pugh Class B Cirrhosis After First-Line TherapyAdvanced Adult Hepatocellular CarcinomaNCT04497038University of Michigan Rogel Cancer Center3