Non-interventional Study of Cabozantinib in Adults With Advanced Renal Cell Carcinoma
- Conditions
- Renal Cell Carcinoma
- Interventions
- Other: Data collection
- 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
- Arm && Interventions
Group Intervention Description Third and later line therapy Data collection Data collection Second line therapy Data collection Data collection
- Primary Outcome Measures
Name Time Method The proportion of subjects with dose modifications due to AEs 12 months
- Secondary Outcome Measures
Name Time Method Description of cabozantinib dose intensity (average daily dose compared to starting dose) 12 months Proportion of subjects with concomitant radiotherapies 12 months Overall best response 12 months Per investigator assessment
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
Krajská Nemocnice Liberec, A.S., Komplexní Onkologické Centrum
🇨🇿Liberec, Czechia
Az Damiaan
🇧🇪Oostende, Belgium
Fakultni Nemocnice na Bulovce, Institut of Radiation Oncology
🇨🇿Praha, Czechia
Thomayerova Nemocnice, Onkologická Klinika 1. LF UK A TN
🇨🇿Praha 4, Czechia
Fakultni Nemocnice Kralovske Vinohrady (FNKV) - Radioterapeuticka a Onkologicka klinika
🇨🇿Praha, Czechia
CHU Angers
🇫🇷Angers, France
CH Cote Basque
🇫🇷Bayonne, France
Centre Hospitalier Universitaire
🇫🇷Besançon, France
Hopital Saint Andre - CHU de Bordeaux
🇫🇷Bordeaux, France
Centre Catalan d'Urologie
🇫🇷Cabestany, France
Centre Maurice Tubiana
🇫🇷Caen, France
Polyclinique Chénieux
🇫🇷Limoges, France
L'institut Mutualiste Montsouris
🇫🇷Paris, France
CHU Henri Mondor
🇫🇷Créteil, France
Grenoble University Hospital
🇫🇷Grenoble, France
Hospital De Cornouaille
🇫🇷Quimper, France
Strasbourg Oncologie Liberale
🇫🇷Strasbourg, France
Centre de Lutte Contre le Cancer (CLCC) - Institut Jean Godinot
🇫🇷Reims, France
Institut de Cancérologie Lucien Neuwirth (ICLN)
🇫🇷Saint-Priest-en-Jarez, France
Hôpitaux Universitaires de Strasbourg
🇫🇷Strasbourg, France
CHU Tours - Hopital Bretonneau
🇫🇷Tours, France
Vivantes Klinikum Neukolln
🇩🇪Berlin, Germany
MVZ- Polyclinic Eisenach
🇩🇪Eisenach, Germany
University Medical Center Hamburg-Eppendorf
🇩🇪Hamburg, Germany
University Medical Center Halle (Saale)
🇩🇪Halle, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
University Medical Center LMU Munich - Campus Grosshadern, Urologische Klinik und Poliklinik Marchionnish R. 15
🇩🇪München, Germany
MVP MP Saaletal Saalfeld/Saale
🇩🇪Saalfeld, Germany
Asklepios Clinic Altona Hamburg
🇩🇪Hamburg, Germany
University Medical Center Ulm
🇩🇪Ulm, Germany
Dept of Urology, Eberhard-Karls-University Tuebingen
🇩🇪Tuebingen, Germany
Evaggelismos Hospital
🇬🇷Athens, Greece
Alexandra Hospital
🇬🇷Athens, Greece
Papageorgiou Hospital
🇬🇷Thessaloníki, Greece
Dep. Medical Oncology, University Hospital of Ioannina
🇬🇷Ioánnina, Greece
Interbalkan Medical Center
🇬🇷Thessaloníki, Greece
Azienda Ospedaliera S.Orsola Malpighi di Bologna
🇮🇹Bologna, Italy
Fondazione IRCCS Istituto Nazionale Dei Tumori
🇮🇹Milano, Italy
Aorn Cardarelli
🇮🇹Napoli, Italy
Azienda Ospedaliero Universitaria di Modena
🇮🇹Modena, Italy
National Cancer Institute "Fondazione G. Pascale" IRCCS
🇮🇹Napoli, Italy
Umberto Basso
🇮🇹Padova, Italy
Fondazione Salvatore Maugeri - I.R.C.C.S
🇮🇹Pavia, Italy
Azienda Ospedaliero-Universitaria di Parma
🇮🇹Parma, Italy
IRCCS Azienda Usl Di Reggio Emilia
🇮🇹Reggio Emilia, Italy
Gemelli Hospital
🇮🇹Roma, Italy
UOC Oncologia Azienda Ospedaliera Sant-Andrea
🇮🇹Rome, Italy
Azienda Ospedaliera Universitaria Integrata Verona
🇮🇹Verona, Italy
Presidio Ospedaliero Santa Chiara
🇮🇹Trento, Italy
San Bortolo General Hospital
🇮🇹Vicenza, Italy
Deventer Hospital
🇳🇱Deventer, Netherlands
Amphia Ziekenhuis
🇳🇱Breda, Netherlands
Onkology Center
🇵🇱Bydgoszcz, Poland
Magodent SP Z O.O.
🇵🇱Warsaw, Poland
Franciscus Gasthuis Hospital
🇳🇱Rotterdam, Netherlands
Hospital Vall de Hebron
🇪🇸Barcelona, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital De La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario de León
🇪🇸León, Spain
Hospital Dr. Josep Trueta
🇪🇸Girona, Spain
Hospital Universitario Lucus Augusti
🇪🇸Lugo, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Morales Meseguer
🇪🇸Murcia, Spain
Hospital Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital Universitario Central de Asturias (Huca)
🇪🇸Oviedo, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Complejo Hospitalario De Navarra
🇪🇸Pamplona, Spain
Hospital Universitario Son Espases
🇪🇸Palma De Mallorca, Spain
Hospital Universitari Parc Tauli
🇪🇸Sabadell, Spain
Complejo Hospitalario Universitario de Compostela
🇪🇸Santiago De Compostela, Spain
Royal Derby Hospital
🇬🇧Derby, United Kingdom
Hospital Clinico Lozano Blesa de Zaragoza
🇪🇸Zaragoza, Spain
Hospital Álvaro Cunqueiro de Vigo
🇪🇸Vigo, Spain
East Kent Hospitals University NHS Foundation Trust
🇬🇧Canterbury, United Kingdom
Freeman Hospital-Northern Centre For Cancer Care
🇬🇧Newcastle, United Kingdom
Mount Vernon Cancer Centre - East and North Hertfordshire NHS Trust
🇬🇧Northwood, United Kingdom
Rosemere Cancer Centre, Royal Preston Hospital
🇬🇧Preston, United Kingdom
Frimley Health NHS Foundation Trust - Wezham Park and Heatherwood Hospitals
🇬🇧Slough, United Kingdom
G.O.H.K "Oi Agioi Anargiroi"
🇬🇷Athens, Greece
Haaglanden Medical Centre
🇳🇱Leidschendam, Netherlands
Wojskowy Instytut Medyczny, Klinika Onkologii
🇵🇱Warsaw, Poland
Saint Savvas Hospital
🇬🇷Athens, Greece
Szpital Kliniczny Przemienienia Panskiego w Poznaniu
🇵🇱Poznań, Poland
Dolnoslaskie Centrum Onkologii
🇵🇱Wrocław, Poland
Universitaetsklinikum Frankfurt - Department of Urology
🇩🇪Frankfurt, Germany