Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS19464 | Registry Identifier | EU PAS Register |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Second line therapy | Data collection |
| |
| Third and later line therapy | Data collection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection | Other | Only available evaluations as decided by the investigator based on local clinical practice will be collected. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with dose modifications due to AEs | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of all treatment-emergent non-serious and serious AEs | 12 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Subjects with advanced RCC following prior VEGF-targeted therapy in real life settings.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kepler University Hospital - Urology | Linz | 4020 | Austria | |||
| Universitatsklinikum fur Urologie und Andrologie |
Not provided
Not provided
Not provided
Not provided
| 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 |
| Proportion of subjects with concomitant radiotherapies | 12 months |
| Description of systemic therapy (drug name) planned following cabozantinib discontinuation | Percentage of subjects treated with the following drugs: Sunitinib, Pazopanib, Axitinib, Sorafenib, Bevacizumab, Cytokines, Everolimus, Lenvatinib, Nivolumab, Tivozanib, Experimental trial drug, Other, Unknown) | 12 months |
| Overall best response | Per investigator assessment | 12 months |
| Median Progression Free Survival (PFS) time | 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) | 12 months |
| 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 |
| Salzburg |
| 5020 |
| Austria |
| Imelda Ziekenhuis | Bonheiden | 2820 | Belgium |
| Az Klina | Brasschaat | 2930 | Belgium |
| UZA | Edegem | 2650 | Belgium |
| Jessa Ziekenhuis | Hasselt | 3500 | Belgium |
| Az Damiaan | Ostend | 8400 | Belgium |
| Krajská Nemocnice Liberec, A.S., Komplexní Onkologické Centrum | Liberec | 460 63 | Czechia |
| Fakultni Nemocnice Kralovske Vinohrady (FNKV) - Radioterapeuticka a Onkologicka klinika | Prague | 100 34 | Czechia |
| Thomayerova Nemocnice, Onkologická Klinika 1. LF UK A TN | Prague | 140 59 | Czechia |
| Fakultni Nemocnice na Bulovce, Institut of Radiation Oncology | Prague | 18081 | Czechia |
| CHU Angers | Angers | 49933 | France |
| CH Cote Basque | Bayonne | 64100 | France |
| Centre Hospitalier Universitaire | Besançon | 25030 | France |
| Hopital Saint Andre - CHU de Bordeaux | Bordeaux | 33075 | France |
| Centre Catalan d'Urologie | Cabestany | 66330 | France |
| Centre Maurice Tubiana | Caen | 14000 | France |
| CHU Henri Mondor | Créteil | 94010 | France |
| Grenoble University Hospital | Grenoble | 38043 | France |
| Polyclinique Chénieux | Limoges | 87039 | France |
| L'institut Mutualiste Montsouris | Paris | 75014 | France |
| Hospital De Cornouaille | Quimper | 29107 | France |
| Centre de Lutte Contre le Cancer (CLCC) - Institut Jean Godinot | Reims | 51726 | France |
| Institut de Cancérologie Lucien Neuwirth (ICLN) | Saint-Priest-en-Jarez | 42270 | France |
| Strasbourg Oncologie Liberale | Strasbourg | 67000 | France |
| Hôpitaux Universitaires de Strasbourg | Strasbourg | 67098 | France |
| CHU Tours - Hopital Bretonneau | Tours | 37044 | France |
| Vivantes Klinikum Neukolln | Berlin | 12351 | Germany |
| MVZ- Polyclinic Eisenach | Eisenach | 99817 | Germany |
| Universitaetsklinikum Frankfurt - Department of Urology | Frankfurt | 60590 | Germany |
| University Medical Center Halle (Saale) | Halle | 06120 | Germany |
| University Medical Center Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Asklepios Clinic Altona Hamburg | Hamburg | 22763 | Germany |
| University Medical Center LMU Munich - Campus Grosshadern, Urologische Klinik und Poliklinik Marchionnish R. 15 | München | 81377 | Germany |
| Universitätsklinikum Münster | Münster | D-48149 | Germany |
| MVP MP Saaletal Saalfeld/Saale | Saalfeld | 73718 | Germany |
| Dept of Urology, Eberhard-Karls-University Tuebingen | Tübingen | 72076 | Germany |
| University Medical Center Ulm | Ulm | 89081 | Germany |
| Evaggelismos Hospital | Athens | 10676 | Greece |
| Saint Savvas Hospital | Athens | 11522 | Greece |
| Alexandra Hospital | Athens | 11528 | Greece |
| G.O.H.K "Oi Agioi Anargiroi" | Athens | 14564 | Greece |
| Dep. Medical Oncology, University Hospital of Ioannina | Ioannina | 45500 | Greece |
| Papageorgiou Hospital | Thessaloniki | 56403 | Greece |
| Interbalkan Medical Center | Thessaloniki | 57001 | Greece |
| Azienda Ospedaliera S.Orsola Malpighi di Bologna | Bologna | 40138 | Italy |
| Fondazione IRCCS Istituto Nazionale Dei Tumori | Milan | 20133 | Italy |
| Azienda Ospedaliero Universitaria di Modena | Modena | 41124 | Italy |
| Aorn Cardarelli | Naples | 80131 | Italy |
| National Cancer Institute "Fondazione G. Pascale" IRCCS | Naples | 80131 | Italy |
| Umberto Basso | Padova | 35128 | Italy |
| Azienda Ospedaliero-Universitaria di Parma | Parma | 43126 | Italy |
| Fondazione Salvatore Maugeri - I.R.C.C.S | Pavia | 27100 | Italy |
| IRCCS Azienda Usl Di Reggio Emilia | Reggio Emilia | 42123 | Italy |
| Gemelli Hospital | Roma | 00168 | Italy |
| UOC Oncologia Azienda Ospedaliera Sant-Andrea | Rome | 00189 | Italy |
| Presidio Ospedaliero Santa Chiara | Trento | 38122 | Italy |
| Azienda Ospedaliera Universitaria Integrata Verona | Verona | 37134 | Italy |
| San Bortolo General Hospital | Vicenza | 36100 | Italy |
| Amphia Ziekenhuis | Breda | 4819 EV | Netherlands |
| Deventer Hospital | Deventer | 7416SE | Netherlands |
| Haaglanden Medical Centre | Leidschendam | 2262 BA | Netherlands |
| Franciscus Gasthuis Hospital | Rotterdam | 3118 JH | Netherlands |
| Onkology Center | Bydgoszcz | 85796 | Poland |
| Szpital Kliniczny Przemienienia Panskiego w Poznaniu | Poznan | 61848 | Poland |
| Magodent SP Z O.O. | Warsaw | 01748 | Poland |
| Wojskowy Instytut Medyczny, Klinika Onkologii | Warsaw | 04141 | Poland |
| Dolnoslaskie Centrum Onkologii | Wroclaw | 53413 | Poland |
| Hospital Vall de Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital De La Santa Creu I Sant Pau | Barcelona | 8025 | Spain |
| Hospital Dr. Josep Trueta | Girona | 17007 | Spain |
| Hospital Universitario de León | León | 24080 | Spain |
| Hospital Universitario Lucus Augusti | Lugo | 27003 | Spain |
| Hospital Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Virgen de la Victoria | Málaga | 29017 | Spain |
| Hospital Morales Meseguer | Murcia | 28034 | Spain |
| Hospital Universitario Central de Asturias (Huca) | Oviedo | 33011 | Spain |
| Hospital Universitario Son Espases | Palma de Mallorca | 07120 | Spain |
| Complejo Hospitalario De Navarra | Pamplona | 31008 | Spain |
| Hospital Universitari Parc Tauli | Sabadell | 08208 | Spain |
| Complejo Hospitalario Universitario de Compostela | Santiago de Compostela | 15706 | Spain |
| Hospital Álvaro Cunqueiro de Vigo | Vigo | 36312 | Spain |
| Hospital Clinico Lozano Blesa de Zaragoza | Zaragoza | 50009 | Spain |
| East Kent Hospitals University NHS Foundation Trust | Canterbury | CT1 3NG | United Kingdom |
| Royal Derby Hospital | Derby | DE22 3NE | United Kingdom |
| Freeman Hospital-Northern Centre For Cancer Care | Newcastle | NE7 7DN | United Kingdom |
| Mount Vernon Cancer Centre - East and North Hertfordshire NHS Trust | Northwood | HA62RN | United Kingdom |
| Rosemere Cancer Centre, Royal Preston Hospital | Preston | PR2 9HT | United Kingdom |
| Frimley Health NHS Foundation Trust - Wezham Park and Heatherwood Hospitals | Slough | SL2 4HL | United Kingdom |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
Not provided
Not provided