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

August 12, 2022 updated by: Ipsen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

689

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, 4020
        • Kepler University Hospital - Urology
      • Salzburg, Austria, 5020
        • Universitatsklinikum fur Urologie und Andrologie
  • Belgium
      • Bonheiden, Belgium, 2820
        • Imelda Ziekenhuis
      • Brasschaat, Belgium, 2930
        • AZ Klina
      • Edegem, Belgium, 2650
        • UZA
      • Hasselt, Belgium, 3500
        • Jessa Ziekenhuis
      • Oostende, Belgium, 8400
        • AZ Damiaan
  • Czechia
      • Liberec, Czechia, 460 63
        • Krajská Nemocnice Liberec, A.S., Komplexní Onkologické Centrum
      • Praha, Czechia, 100 34
        • Fakultni Nemocnice Kralovske Vinohrady (FNKV) - Radioterapeuticka a Onkologicka klinika
      • Praha, Czechia, 18081
        • Fakultni Nemocnice na Bulovce, Institut of Radiation Oncology
      • Praha 4, Czechia, 140 59
        • Thomayerova Nemocnice, Onkologická Klinika 1. LF UK A TN
  • France
      • Angers, France, 49933
        • CHU Angers
      • Bayonne, France, 64100
        • CH Côte Basque
      • Besançon, France, 25030
        • Centre Hospitalier Universitaire
      • Bordeaux, France, 33075
        • Hopital Saint Andre - CHU de Bordeaux
      • Cabestany, France, 66330
        • Centre Catalan d'Urologie
      • Caen, France, 14000
        • Centre Maurice Tubiana
      • Créteil, France, 94010
        • CHU Henri Mondor
      • Grenoble, France, 38043
        • Grenoble University Hospital
      • Limoges, France, 87039
        • Polyclinique Chenieux
      • Paris, France, 75014
        • L'Institut Mutualiste Montsouris
      • Quimper, France, 29107
        • Hospital De Cornouaille
      • Reims, France, 51726
        • Centre de Lutte Contre le Cancer (CLCC) - Institut Jean Godinot
      • Saint-Priest-en-Jarez, France, 42270
        • Institut de Cancérologie Lucien Neuwirth (ICLN)
      • Strasbourg, France, 67000
        • Strasbourg Oncologie Libérale
      • Strasbourg, France, 67098
        • Hopitaux Universitaires de Strasbourg
      • Tours, France, 37044
        • CHU Tours - Hôpital Bretonneau
  • Germany
      • Berlin, Germany, 12351
        • Vivantes Klinikum Neukölln
      • Eisenach, Germany, 99817
        • MVZ- Polyclinic Eisenach
      • Frankfurt, Germany, 60590
        • Universitaetsklinikum Frankfurt - Department of Urology
      • Halle, Germany, 06120
        • University Medical Center Halle (Saale)
      • Hamburg, Germany, 20246
        • University Medical Center Hamburg-Eppendorf
      • Hamburg, Germany, 22763
        • Asklepios Clinic Altona Hamburg
      • München, Germany, 81377
        • University Medical Center LMU Munich - Campus Grosshadern, Urologische Klinik und Poliklinik Marchionnish R. 15
      • Münster, Germany, D-48149
        • Universitätsklinikum Münster
      • Saalfeld, Germany, 73718
        • MVP MP Saaletal Saalfeld/Saale
      • Tuebingen, Germany, 72076
        • Dept of Urology, Eberhard-Karls-University Tuebingen
      • Ulm, Germany, 89081
        • University Medical Center Ulm
  • Greece
      • Athens, Greece, 10676
        • Evaggelismos Hospital
      • Athens, Greece, 11528
        • Alexandra Hospital
      • Athens, Greece, 11522
        • Saint Savvas Hospital
      • Athens, Greece, 14564
        • G.O.H.K "Oi Agioi Anargiroi"
      • Ioánnina, Greece, 45500
        • Dep. Medical Oncology, University Hospital of Ioannina
      • Thessaloníki, Greece, 56403
        • Papageorgiou Hospital
      • Thessaloníki, Greece, 57001
        • Interbalkan Medical Center
  • Italy
      • Bologna, Italy, 40138
        • Azienda Ospedaliera S.Orsola Malpighi di Bologna
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Modena, Italy, 41124
        • Azienda Ospedaliero Universitaria di Modena
      • Napoli, Italy, 80131
        • AORN Cardarelli
      • Napoli, Italy, 80131
        • National Cancer Institute "Fondazione G. Pascale" IRCCS
      • Padova, Italy, 35128
        • Umberto Basso
      • Parma, Italy, 43126
        • Azienda Ospedaliero-Universitaria di Parma
      • Pavia, Italy, 27100
        • Fondazione Salvatore Maugeri - I.R.C.C.S
      • Reggio Emilia, Italy, 42123
        • IRCCS Azienda Usl Di Reggio Emilia
      • Roma, Italy, 00168
        • Gemelli Hospital
      • Rome, Italy, 00189
        • UOC Oncologia Azienda Ospedaliera Sant-Andrea
      • Trento, Italy, 38122
        • Presidio Ospedaliero Santa Chiara
      • Verona, Italy, 37134
        • Azienda Ospedaliera Universitaria Integrata Verona
      • Vicenza, Italy, 36100
        • San Bortolo General Hospital
  • Netherlands
      • Breda, Netherlands, 4819 EV
        • Amphia Ziekenhuis
      • Deventer, Netherlands, 7416SE
        • Deventer Hospital
      • Leidschendam, Netherlands, 2262 BA
        • Haaglanden Medical Centre
      • Rotterdam, Netherlands, 3118 JH
        • Franciscus Gasthuis Hospital
  • Poland
      • Bydgoszcz, Poland, 85796
        • Onkology Center
      • Poznań, Poland, 61848
        • Szpital Kliniczny Przemienienia Panskiego w Poznaniu
      • Warsaw, Poland, 01748
        • Magodent SP Z O.O.
      • Warsaw, Poland, 04141
        • Wojskowy Instytut Medyczny, Klinika Onkologii
      • Wrocław, Poland, 53413
        • Dolnoslaskie Centrum Onkologii
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Vall de Hebron
      • Barcelona, Spain, 8025
        • Hospital de la Santa Creu i Sant Pau
      • Girona, Spain, 17007
        • Hospital Dr. Josep Trueta
      • León, Spain, 24080
        • Hospital Universitario de Leon
      • Lugo, Spain, 27003
        • Hospital Universitario Lucus Augusti
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Madrid, Spain, 28041
        • Hospital 12 De Octubre
      • Murcia, Spain, 28034
        • Hospital Morales Meseguer
      • Málaga, Spain, 29017
        • Hospital Virgen de la Victoria
      • Oviedo, Spain, 33011
        • Hospital Universitario Central de Asturias (HUCA)
      • Palma De Mallorca, Spain, 07120
        • Hospital Universitario Son Espases
      • Pamplona, Spain, 31008
        • Complejo Hospitalario de Navarra
      • Sabadell, Spain, 08208
        • Hospital Universitari Parc Tauli
      • Santiago De Compostela, Spain, 15706
        • Complejo Hospitalario Universitario de Compostela
      • Vigo, Spain, 36312
        • Hospital Álvaro Cunqueiro de Vigo
      • Zaragoza, Spain, 50009
        • Hospital Clínico Lozano Blesa de Zaragoza
  • United Kingdom
      • Canterbury, United Kingdom, CT1 3NG
        • East Kent Hospitals University NHS Foundation Trust
      • Derby, United Kingdom, DE22 3NE
        • Royal Derby Hospital
      • Newcastle, United Kingdom, NE7 7DN
        • Freeman Hospital-Northern Centre For Cancer Care
      • Northwood, United Kingdom, HA62RN
        • Mount Vernon Cancer Centre - East and North Hertfordshire NHS Trust
      • Preston, United Kingdom, PR2 9HT
        • Rosemere Cancer Centre, Royal Preston Hospital
      • Slough, United Kingdom, SL2 4HL
        • Frimley Health NHS Foundation Trust - Wezham Park and Heatherwood Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with advanced RCC following prior VEGF-targeted therapy in real life settings.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Second line therapy
Data collection
Other: Data collection
Only available evaluations as decided by the investigator based on local clinical practice will be collected.
Third and later line therapy
Data collection
Other: Data collection
Only available evaluations as decided by the investigator based on local clinical practice will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of subjects with dose modifications due to AEs
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reason for cabozantinib dose modification (any modification, reduction, temporary interruption or discontinuation)
Time Frame: 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
12 months
Description of number of cabozantinib dose modifications (any modification, reduction, temporary interruption, increase or discontinuation)
Time Frame: 12 months
12 months
Median time to first cabozantinib dose modification (any modification, reduction, temporary interruption, increase or discontinuation) due to AEs and for any reason
Time Frame: 12 months
12 months
Description of cabozantinib starting dose (combination of dose per intake and frequency)
Time Frame: 12 months
12 months
Description of daily dose of cabozantinib received
Time Frame: 12 months
12 months
Description of cabozantinib dose intensity (average daily dose compared to starting dose)
Time Frame: 12 months
12 months
Duration of cabozantinib treatment (expressed as mean and median time to end of treatment)
Time Frame: 12 months
12 months
Proportion of subjects with concomitant radiotherapies
Time Frame: 12 months
12 months
Description of systemic therapy (drug name) planned following cabozantinib discontinuation
Time Frame: 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)
12 months
Overall best response
Time Frame: 12 months
Per investigator assessment
12 months
Median Progression Free Survival (PFS) time
Time Frame: 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)
12 months
Overall Survival (OS) rate at the end of the study
Time Frame: 12 months
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
Time Frame: 12 months
12 months
Health care resource utilisation: Description of concomitant medications (by drug class and preferred name) associated with the management of treatment-related AEs
Time Frame: 12 months
12 months
Health care resource utilisation: Description of number of unplanned laboratory tests associated with the management of treatment-related AEs
Time Frame: 12 months
12 months

Other Outcome Measures

Outcome Measure
Time Frame
Incidence of all treatment-emergent non-serious and serious AEs
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2018

Primary Completion (Actual)

May 19, 2022

Study Completion (Actual)

May 19, 2022

Study Registration Dates

First Submitted

December 15, 2017

First Submitted That Met QC Criteria

January 26, 2018

First Posted (Actual)

February 5, 2018

Study Record Updates

Last Update Posted (Actual)

August 15, 2022

Last Update Submitted That Met QC Criteria

August 12, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-FR-60000-001
  • EUPAS19464 (Registry Identifier: EU PAS Register)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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