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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The proportion of subjects with dose modifications due to AEs
Time Frame: 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 19, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 19, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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