Non-interventional Study of Cabozantinib in Adults With Advanced Renal Cell Carcinoma
CASSIOPE
Prospective Non Interventional Study of Cabozantinib Tablets in Adults With Advanced Renal Cell Carcinoma Following Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Therapy
2 other identifiers
observational
689
11 countries
91
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2018
Longer than P75 for all trials
91 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2017
CompletedFirst Posted
Study publicly available on registry
February 5, 2018
CompletedStudy Start
First participant enrolled
April 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 19, 2022
CompletedAugust 15, 2022
August 1, 2022
4.1 years
December 15, 2017
August 12, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The proportion of subjects with dose modifications due to AEs
12 months
Secondary Outcomes (15)
Reason for cabozantinib dose modification (any modification, reduction, temporary interruption or discontinuation)
12 months
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
- +10 more secondary outcomes
Other Outcomes (1)
Incidence of all treatment-emergent non-serious and serious AEs
12 months
Study Arms (2)
Second line therapy
Data collection
Third and later line therapy
Data collection
Interventions
Only available evaluations as decided by the investigator based on local clinical practice will be collected.
Eligibility Criteria
Subjects with advanced RCC following prior VEGF-targeted therapy in real life settings.
You may qualify if:
- Age ≥18 years old
- Has a diagnosis of advanced RCC
- Has received at least one prior VEGF-targeted therapy
- Not concurrently involved in an interventional study
- Consents to participate in this noninterventional study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (91)
Kepler University Hospital - Urology
Linz, 4020, Austria
Universitatsklinikum fur Urologie und Andrologie
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
Napoli, 80131, Italy
National Cancer Institute "Fondazione G. Pascale" IRCCS
Napoli, 80131, Italy
Umberto Basso
Padua, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2017
First Posted
February 5, 2018
Study Start
April 24, 2018
Primary Completion
May 19, 2022
Study Completion
May 19, 2022
Last Updated
August 15, 2022
Record last verified: 2022-08