Clinical trial NCT03419572: Non-interventional Study of Cabozantinib in Adults With Advanced Renal Cell Carcinoma
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2018-02-05
Enrollment: 689
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with advanced RCC following prior VEGF-targeted therapy in real life settings.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of subjects with dose modifications due to AEs
timeFrame: 12 months
Secondary outcomes:
measure: Reason for cabozantinib dose modification (any modification, reduction, temporary interruption or discontinuation)
timeFrame: 12 months
measure: Description of number of cabozantinib dose modifications (any modification, reduction, temporary interruption, increase or discontinuation)
timeFrame: 12 months
measure: Median time to first cabozantinib dose modification (any modification, reduction, temporary interruption, increase or discontinuation) due to AEs and for any reason
timeFrame: 12 months
measure: Description of cabozantinib starting dose (combination of dose per intake and frequency)
timeFrame: 12 months
measure: Description of daily dose of cabozantinib received
timeFrame: 12 months
measure: Description of cabozantinib dose intensity (average daily dose compared to starting dose)
timeFrame: 12 months
measure: Duration of cabozantinib treatment (expressed as mean and median time to end of treatment)
timeFrame: 12 months
measure: Proportion of subjects with concomitant radiotherapies
timeFrame: 12 months
measure: Description of systemic therapy (drug name) planned following cabozantinib discontinuation
timeFrame: 12 months
measure: Overall best response
timeFrame: 12 months
measure: Median Progression Free Survival (PFS) time
timeFrame: 12 months
measure: Overall Survival (OS) rate at the end of the study
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: Health care resource utilisation: Description of concomitant medications (by drug class and preferred name) associated with the management of treatment-related AEs
timeFrame: 12 months
measure: Health care resource utilisation: Description of number of unplanned laboratory tests associated with the management of treatment-related AEs
timeFrame: 12 months
Other outcomes:
measure: Incidence of all treatment-emergent non-serious and serious AEs
timeFrame: 12 months
Locations:
city: Linz
country: Austria
facility: Kepler University Hospital - Urology
city: Salzburg
country: Austria
facility: Universitatsklinikum fur Urologie und Andrologie
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Brasschaat
country: Belgium
facility: Az Klina
city: Edegem
country: Belgium
facility: UZA
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Oostende
country: Belgium
facility: Az Damiaan
city: Liberec
country: Czechia
facility: Krajská Nemocnice Liberec, A.S., Komplexní Onkologické Centrum
city: Praha 4
country: Czechia
facility: Thomayerova Nemocnice, Onkologická Klinika 1. LF UK A TN
city: Praha
country: Czechia
facility: Fakultni Nemocnice Kralovske Vinohrady (FNKV) - Radioterapeuticka a Onkologicka klinika
city: Praha
country: Czechia
facility: Fakultni Nemocnice na Bulovce, Institut of Radiation Oncology
city: Angers
country: France
facility: CHU Angers
city: Bayonne
country: France
facility: CH Cote Basque
city: Besançon
country: France
facility: Centre Hospitalier Universitaire
city: Bordeaux
country: France
facility: Hopital Saint Andre - CHU de Bordeaux
city: Cabestany
country: France
facility: Centre Catalan d'Urologie
city: Caen
country: France
facility: Centre Maurice Tubiana
city: Créteil
country: France
facility: CHU Henri Mondor
city: Grenoble
country: France
facility: Grenoble University Hospital
city: Limoges
country: France
facility: Polyclinique Chénieux
city: Paris
country: France
facility: L'institut Mutualiste Montsouris
city: Quimper
country: France
facility: Hospital De Cornouaille
city: Reims
country: France
facility: Centre de Lutte Contre le Cancer (CLCC) - Institut Jean Godinot
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie Lucien Neuwirth (ICLN)
city: Strasbourg
country: France
facility: Strasbourg Oncologie Liberale
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
city: Tours
country: France
facility: CHU Tours - Hopital Bretonneau
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukolln
city: Eisenach
country: Germany
facility: MVZ- Polyclinic Eisenach
city: Frankfurt
country: Germany
facility: Universitaetsklinikum Frankfurt - Department of Urology
city: Halle
country: Germany
facility: University Medical Center Halle (Saale)
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Asklepios Clinic Altona Hamburg
city: München
country: Germany
facility: University Medical Center LMU Munich - Campus Grosshadern, Urologische Klinik und Poliklinik Marchionnish R. 15
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Saalfeld
country: Germany
facility: MVP MP Saaletal Saalfeld/Saale
city: Tuebingen
country: Germany
facility: Dept of Urology, Eberhard-Karls-University Tuebingen
city: Ulm
country: Germany
facility: University Medical Center Ulm
city: Athens
country: Greece
facility: Evaggelismos Hospital
city: Athens
country: Greece
facility: Saint Savvas Hospital
city: Athens
country: Greece
facility: Alexandra Hospital
city: Athens
country: Greece
facility: G.O.H.K "Oi Agioi Anargiroi"
city: Ioánnina
country: Greece
facility: Dep. Medical Oncology, University Hospital of Ioannina
city: Thessaloníki
country: Greece
facility: Papageorgiou Hospital
city: Thessaloníki
country: Greece
facility: Interbalkan Medical Center
city: Bologna
country: Italy
facility: Azienda Ospedaliera S.Orsola Malpighi di Bologna
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale Dei Tumori
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria di Modena
city: Napoli
country: Italy
facility: Aorn Cardarelli
city: Napoli
country: Italy
facility: National Cancer Institute "Fondazione G. Pascale" IRCCS
city: Padova
country: Italy
facility: Umberto Basso
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
city: Pavia
country: Italy
facility: Fondazione Salvatore Maugeri - I.R.C.C.S
city: Reggio Emilia
country: Italy
facility: IRCCS Azienda Usl Di Reggio Emilia
city: Roma
country: Italy
facility: Gemelli Hospital
city: Rome
country: Italy
facility: UOC Oncologia Azienda Ospedaliera Sant-Andrea
city: Trento
country: Italy
facility: Presidio Ospedaliero Santa Chiara
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
city: Vicenza
country: Italy
facility: San Bortolo General Hospital
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Deventer
country: Netherlands
facility: Deventer Hospital
city: Leidschendam
country: Netherlands
facility: Haaglanden Medical Centre
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis Hospital
city: Bydgoszcz
country: Poland
facility: Onkology Center
city: Poznań
country: Poland
facility: Szpital Kliniczny Przemienienia Panskiego w Poznaniu
city: Warsaw
country: Poland
facility: Magodent SP Z O.O.
city: Warsaw
country: Poland
facility: Wojskowy Instytut Medyczny, Klinika Onkologii
city: Wrocław
country: Poland
facility: Dolnoslaskie Centrum Onkologii
city: Barcelona
country: Spain
facility: Hospital Vall de Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital De La Santa Creu I Sant Pau
city: Girona
country: Spain
facility: Hospital Dr. Josep Trueta
city: León
country: Spain
facility: Hospital Universitario de León
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Murcia
country: Spain
facility: Hospital Morales Meseguer
city: Málaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias (Huca)
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
city: Pamplona
country: Spain
facility: Complejo Hospitalario De Navarra
city: Sabadell
country: Spain
facility: Hospital Universitari Parc Tauli
city: Santiago De Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Compostela
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro de Vigo
city: Zaragoza
country: Spain
facility: Hospital Clinico Lozano Blesa de Zaragoza
city: Canterbury
country: United Kingdom
facility: East Kent Hospitals University NHS Foundation Trust
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Newcastle
country: United Kingdom
facility: Freeman Hospital-Northern Centre For Cancer Care
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre - East and North Hertfordshire NHS Trust
city: Preston
country: United Kingdom
facility: Rosemere Cancer Centre, Royal Preston Hospital
city: Slough
country: United Kingdom
facility: Frimley Health NHS Foundation Trust - Wezham Park and Heatherwood Hospitals
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: