Renal Cell Carcinoma
Conditions
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).
Interventions
OTHERData collection
Only available evaluations as decided by the investigator based on local clinical practice will be collected.
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with dose modifications due to AEs | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Description of number of cabozantinib dose modifications (any modification, reduction, temporary interruption, increase 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 cabozantinib starting dose (combination of dose per intake and frequency) | 12 months | — |
| Description of daily dose of cabozantinib received | 12 months | — |
| Description of cabozantinib dose intensity (average daily dose compared to starting dose) | 12 months | — |
| Duration of cabozantinib treatment (expressed as mean and median time to end of treatment) | 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 best response | 12 months | Per investigator assessment |
| 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) |
| Overall Survival (OS) rate at the end of the study | 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 | — |
| Health care resource utilisation: Description of concomitant medications (by drug class and preferred name) associated with the management of treatment-related AEs | 12 months | — |
| Health care resource utilisation: Description of number of unplanned laboratory tests associated with the management of treatment-related AEs | 12 months | — |
| Proportion of subjects with concomitant radiotherapies | 12 months | — |
Other
| Measure | Time frame |
|---|---|
| Incidence of all treatment-emergent non-serious and serious AEs | 12 months |
Countries
Austria, Belgium, Czechia, France, Germany, Greece, Italy, Netherlands, Poland, Spain, United Kingdom
Outcome results
None listed