Non-interventional Study of Cabozantinib in Adults With Advanced Renal Cell Carcinoma
- Conditions
- Renal Cell Carcinoma
- Registration Number
- NCT03419572
- Lead Sponsor
- Ipsen
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 689
- 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
- There are no exclusion criteria for this study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of subjects with dose modifications due to AEs 12 months
- Secondary Outcome Measures
Name Time Method Overall best response 12 months Per investigator assessment
Description of cabozantinib dose intensity (average daily dose compared to starting dose) 12 months Proportion of subjects with concomitant radiotherapies 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 Defined as the time between the start date of cabozantinib and the date of progression or death. Clinical and radiographic (assessed by the investigator based on RECIST 1.1)
Reason for cabozantinib dose modification (any modification, reduction, temporary interruption or discontinuation) 12 months Percentage of subjects with the following reasons - Disease progression, Adverse event, Subject non-compliance, Treatment resumed or re escalated, Subject decision, Clinical / investigator decision, Other
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 Percentage of subjects treated with the following drugs: Sunitinib, Pazopanib, Axitinib, Sorafenib, Bevacizumab, Cytokines, Everolimus, Lenvatinib, Nivolumab, Tivozanib, Experimental trial drug, Other, Unknown)
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
Trial Locations
- Locations (91)
Kepler University Hospital - Urology
🇦🇹Linz, Austria
Universitatsklinikum fur Urologie und Andrologie
🇦🇹Salzburg, Austria
Imelda Ziekenhuis
🇧🇪Bonheiden, Belgium
Az Klina
🇧🇪Brasschaat, Belgium
UZA
🇧🇪Edegem, Belgium
Jessa Ziekenhuis
🇧🇪Hasselt, Belgium
Az Damiaan
🇧🇪Oostende, Belgium
Krajská Nemocnice Liberec, A.S., Komplexní Onkologické Centrum
🇨🇿Liberec, Czechia
Thomayerova Nemocnice, Onkologická Klinika 1. LF UK A TN
🇨🇿Praha 4, Czechia
Fakultni Nemocnice Kralovske Vinohrady (FNKV) - Radioterapeuticka a Onkologicka klinika
🇨🇿Praha, Czechia
Scroll for more (81 remaining)Kepler University Hospital - Urology🇦🇹Linz, Austria