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

Renal Cell Carcinoma Clinical Trial

— CASSIOPE  

Official title:

Prospective Non Interventional Study of Cabozantinib Tablets in Adults With Advanced Renal Cell Carcinoma Following Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03419572
• Other study ID #: F-FR-60000-001
• Secondary ID: EUPAS19464
• Status: Completed
• Start date: April 24, 2018
• Est. completion date: May 19, 2022

Study information

• Verified date: August 2022
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 689
• Est. completion date: May 19, 2022
• Est. primary completion date: May 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Other:
• Data collection
Only available evaluations as decided by the investigator based on local clinical practice will be collected.

Locations

Country	Name	City	State
Austria	Kepler University Hospital - Urology	Linz
Austria	Universitatsklinikum fur Urologie und Andrologie	Salzburg
Belgium	Imelda Ziekenhuis	Bonheiden
Belgium	Az Klina	Brasschaat
Belgium	UZA	Edegem
Belgium	Jessa Ziekenhuis	Hasselt
Belgium	Az Damiaan	Oostende
Czechia	Krajská Nemocnice Liberec, A.S., Komplexní Onkologické Centrum	Liberec
Czechia	Fakultni Nemocnice Kralovske Vinohrady (FNKV) - Radioterapeuticka a Onkologicka klinika	Praha
Czechia	Fakultni Nemocnice na Bulovce, Institut of Radiation Oncology	Praha
Czechia	Thomayerova Nemocnice, Onkologická Klinika 1. LF UK A TN	Praha 4
France	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	CHU Henri Mondor	Créteil
France	Grenoble University Hospital	Grenoble
France	Polyclinique Chénieux	Limoges
France	L'institut Mutualiste Montsouris	Paris
France	Hospital De Cornouaille	Quimper
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	Strasbourg Oncologie Liberale	Strasbourg
France	CHU Tours - Hopital Bretonneau	Tours
Germany	Vivantes Klinikum Neukolln	Berlin
Germany	MVZ- Polyclinic Eisenach	Eisenach
Germany	Universitaetsklinikum Frankfurt - Department of Urology	Frankfurt
Germany	University Medical Center Halle (Saale)	Halle
Germany	Asklepios Clinic Altona Hamburg	Hamburg
Germany	University Medical Center Hamburg-Eppendorf	Hamburg
Germany	University Medical Center LMU Munich - Campus Grosshadern, Urologische Klinik und Poliklinik Marchionnish R. 15	München
Germany	Universitätsklinikum Münster	Münster
Germany	MVP MP Saaletal Saalfeld/Saale	Saalfeld
Germany	Dept of Urology, Eberhard-Karls-University Tuebingen	Tuebingen
Germany	University Medical Center Ulm	Ulm
Greece	Alexandra Hospital	Athens
Greece	Evaggelismos Hospital	Athens
Greece	G.O.H.K "Oi Agioi Anargiroi"	Athens
Greece	Saint Savvas Hospital	Athens
Greece	Dep. Medical Oncology, University Hospital of Ioannina	Ioánnina
Greece	Interbalkan Medical Center	Thessaloníki
Greece	Papageorgiou Hospital	Thessaloníki
Italy	Azienda Ospedaliera S.Orsola Malpighi di Bologna	Bologna
Italy	Fondazione IRCCS Istituto Nazionale Dei Tumori	Milano
Italy	Azienda Ospedaliero Universitaria di Modena	Modena
Italy	Aorn Cardarelli	Napoli
Italy	National Cancer Institute "Fondazione G. Pascale" IRCCS	Napoli
Italy	Umberto Basso	Padova
Italy	Azienda Ospedaliero-Universitaria di Parma	Parma
Italy	Fondazione Salvatore Maugeri - I.R.C.C.S	Pavia
Italy	IRCCS Azienda Usl Di Reggio Emilia	Reggio Emilia
Italy	Gemelli Hospital	Roma
Italy	UOC Oncologia Azienda Ospedaliera Sant-Andrea	Rome
Italy	Presidio Ospedaliero Santa Chiara	Trento
Italy	Azienda Ospedaliera Universitaria Integrata Verona	Verona
Italy	San Bortolo General Hospital	Vicenza
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Deventer Hospital	Deventer
Netherlands	Haaglanden Medical Centre	Leidschendam
Netherlands	Franciscus Gasthuis Hospital	Rotterdam
Poland	Onkology Center	Bydgoszcz
Poland	Szpital Kliniczny Przemienienia Panskiego w Poznaniu	Poznan
Poland	Magodent SP Z O.O.	Warsaw
Poland	Wojskowy Instytut Medyczny, Klinika Onkologii	Warsaw
Poland	Dolnoslaskie Centrum Onkologii	Wroclaw
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital De La Santa Creu I Sant Pau	Barcelona
Spain	Hospital Vall de Hebron	Barcelona
Spain	Hospital Dr. Josep Trueta	Girona
Spain	Hospital Universitario de León	León
Spain	Hospital Universitario Lucus Augusti	Lugo
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Virgen de la Victoria	Málaga
Spain	Hospital Morales Meseguer	Murcia
Spain	Hospital Universitario Central de Asturias (Huca)	Oviedo
Spain	Hospital Universitario Son Espases	Palma De Mallorca
Spain	Complejo Hospitalario De Navarra	Pamplona
Spain	Hospital Universitari Parc Tauli	Sabadell
Spain	Complejo Hospitalario Universitario de Compostela	Santiago De Compostela
Spain	Hospital Álvaro Cunqueiro de Vigo	Vigo
Spain	Hospital Clinico Lozano Blesa de Zaragoza	Zaragoza
United Kingdom	East Kent Hospitals University NHS Foundation Trust	Canterbury
United Kingdom	Royal Derby Hospital	Derby
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

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

Austria,  Belgium,  Czechia,  France,  Germany,  Greece,  Italy,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of all treatment-emergent non-serious and serious AEs		12 months
Primary	The proportion of subjects with dose modifications due to AEs		12 months
Secondary	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
Secondary	Description of number of cabozantinib dose modifications (any modification, reduction, temporary interruption, increase or discontinuation)		12 months
Secondary	Median time to first cabozantinib dose modification (any modification, reduction, temporary interruption, increase or discontinuation) due to AEs and for any reason		12 months
Secondary	Description of cabozantinib starting dose (combination of dose per intake and frequency)		12 months
Secondary	Description of daily dose of cabozantinib received		12 months
Secondary	Description of cabozantinib dose intensity (average daily dose compared to starting dose)		12 months
Secondary	Duration of cabozantinib treatment (expressed as mean and median time to end of treatment)		12 months
Secondary	Proportion of subjects with concomitant radiotherapies		12 months
Secondary	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
Secondary	Overall best response	Per investigator assessment	12 months
Secondary	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
Secondary	Overall Survival (OS) rate at the end of the study		12 months
Secondary	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
Secondary	Health care resource utilisation: Description of concomitant medications (by drug class and preferred name) associated with the management of treatment-related AEs		12 months
Secondary	Health care resource utilisation: Description of number of unplanned laboratory tests associated with the management of treatment-related AEs		12 months