Non-interventional Study of Cabozantinib in Adults With Advanced Renal Cell Carcinoma

N/ACompletedNCT03419572

Ipsen689 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

689

Conditions

Renal Cell Carcinoma

Interventions

Data collectionOTHER

Only available evaluations as decided by the investigator based on local clinical practice will be collected.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 exclusion criteria for this study.

Locations (91)

Outcomes

Primary Outcomes

The proportion of subjects with dose modifications due to AEs

Time frame: 12 months

Secondary Outcomes

Reason for cabozantinib dose modification (any modification, reduction, temporary interruption or discontinuation)

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

Time frame: 12 months

Description of number of cabozantinib dose modifications (any modification, reduction, temporary interruption, increase or discontinuation)

Time frame: 12 months

Median time to first cabozantinib dose modification (any modification, reduction, temporary interruption, increase or discontinuation) due to AEs and for any reason

Time frame: 12 months

Description of cabozantinib starting dose (combination of dose per intake and frequency)

Time frame: 12 months

Description of daily dose of cabozantinib received

Time frame: 12 months

Description of cabozantinib dose intensity (average daily dose compared to starting dose)

Time frame: 12 months

Duration of cabozantinib treatment (expressed as mean and median time to end of treatment)

Time frame: 12 months

Proportion of subjects with concomitant radiotherapies

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

Ostend, Belgium

Krajská Nemocnice Liberec, A.S., Komplexní Onkologické Centrum

Liberec, Czechia

Fakultni Nemocnice Kralovske Vinohrady (FNKV) - Radioterapeuticka a Onkologicka klinika

Prague, Czechia

Thomayerova Nemocnice, Onkologická Klinika 1. LF UK A TN

Prague, Czechia

...and 81 more locations