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Renal Cell CarcinomaCASSIOPENCT03419572

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

An observational study of Renal Cell Carcinoma, run by Ipsen at 91 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Data collection
How many people
689 participants
Where
91 sitesin 11 countries
Study dates
24 Apr 2018to 19 May 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • There are no exclusion criteria for this study.

Trial locations and contacts

91 sites in 11 countries.

91 sites in 11 countries

Spain17 sites

  • Hospital Vall de Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital De La Santa Creu I Sant Pau

    Barcelona, 8025

  • Hospital Dr. Josep Trueta

    Girona, 17007

  • Hospital Universitario de León

    León, 24080

  • Hospital Universitario Lucus Augusti

    Lugo, 27003

  • Hospital Ramón y Cajal

    Madrid, 28034

  • Hospital 12 de Octubre

    Madrid, 28041

  • Hospital Virgen de la Victoria

    Málaga, 29017

  • Hospital Morales Meseguer

    Murcia, 28034

  • Hospital Universitario Central de Asturias (Huca)

    Oviedo, 33011

  • Hospital Universitario Son Espases

    Palma de Mallorca, 07120

  • Complejo Hospitalario De Navarra

    Pamplona, 31008

  • Hospital Universitari Parc Tauli

    Sabadell, 08208

  • Complejo Hospitalario Universitario de Compostela

    Santiago de Compostela, 15706

  • Hospital Álvaro Cunqueiro de Vigo

    Vigo, 36312

  • Hospital Clinico Lozano Blesa de Zaragoza

    Zaragoza, 50009

Other trials in Spain

France16 sites

  • CHU Angers

    Angers, 49933

  • CH Cote Basque

    Bayonne, 64100

  • Centre Hospitalier Universitaire

    Besançon, 25030

  • Hopital Saint Andre - CHU de Bordeaux

    Bordeaux, 33075

  • Centre Catalan d'Urologie

    Cabestany, 66330

  • Centre Maurice Tubiana

    Caen, 14000

  • CHU Henri Mondor

    Créteil, 94010

  • Grenoble University Hospital

    Grenoble, 38043

  • Polyclinique Chénieux

    Limoges, 87039

  • L'institut Mutualiste Montsouris

    Paris, 75014

  • Hospital De Cornouaille

    Quimper, 29107

  • Centre de Lutte Contre le Cancer (CLCC) - Institut Jean Godinot

    Reims, 51726

  • Institut de Cancérologie Lucien Neuwirth (ICLN)

    Saint-Priest-en-Jarez, 42270

  • Strasbourg Oncologie Liberale

    Strasbourg, 67000

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67098

  • CHU Tours - Hopital Bretonneau

    Tours, 37044

Other trials in France

Italy14 sites

  • Azienda Ospedaliera S.Orsola Malpighi di Bologna

    Bologna, 40138

  • Fondazione IRCCS Istituto Nazionale Dei Tumori

    Milan, 20133

  • Azienda Ospedaliero Universitaria di Modena

    Modena, 41124

  • Aorn Cardarelli

    Naples, 80131

  • National Cancer Institute "Fondazione G. Pascale" IRCCS

    Naples, 80131

  • Umberto Basso

    Padova, 35128

  • Azienda Ospedaliero-Universitaria di Parma

    Parma, 43126

  • Fondazione Salvatore Maugeri - I.R.C.C.S

    Pavia, 27100

  • IRCCS Azienda Usl Di Reggio Emilia

    Reggio Emilia, 42123

  • Gemelli Hospital

    Roma, 00168

  • UOC Oncologia Azienda Ospedaliera Sant-Andrea

    Rome, 00189

  • Presidio Ospedaliero Santa Chiara

    Trento, 38122

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37134

  • San Bortolo General Hospital

    Vicenza, 36100

Other trials in Italy

Germany11 sites

  • Vivantes Klinikum Neukolln

    Berlin, 12351

  • MVZ- Polyclinic Eisenach

    Eisenach, 99817

  • Universitaetsklinikum Frankfurt - Department of Urology

    Frankfurt, 60590

  • University Medical Center Halle (Saale)

    Halle, 06120

  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20246

  • Asklepios Clinic Altona Hamburg

    Hamburg, 22763

  • University Medical Center LMU Munich - Campus Grosshadern, Urologische Klinik und Poliklinik Marchionnish R. 15

    München, 81377

  • Universitätsklinikum Münster

    Münster, D-48149

  • MVP MP Saaletal Saalfeld/Saale

    Saalfeld, 73718

  • Dept of Urology, Eberhard-Karls-University Tuebingen

    Tübingen, 72076

  • University Medical Center Ulm

    Ulm, 89081

Other trials in Germany

Greece7 sites

  • Evaggelismos Hospital

    Athens, 10676

  • Saint Savvas Hospital

    Athens, 11522

  • Alexandra Hospital

    Athens, 11528

  • G.O.H.K "Oi Agioi Anargiroi"

    Athens, 14564

  • Dep. Medical Oncology, University Hospital of Ioannina

    Ioannina, 45500

  • Papageorgiou Hospital

    Thessaloniki, 56403

  • Interbalkan Medical Center

    Thessaloniki, 57001

Other trials in Greece

United Kingdom6 sites

  • East Kent Hospitals University NHS Foundation Trust

    Canterbury, CT1 3NG

  • Royal Derby Hospital

    Derby, DE22 3NE

  • Freeman Hospital-Northern Centre For Cancer Care

    Newcastle, NE7 7DN

  • Mount Vernon Cancer Centre - East and North Hertfordshire NHS Trust

    Northwood, HA62RN

  • Rosemere Cancer Centre, Royal Preston Hospital

    Preston, PR2 9HT

  • Frimley Health NHS Foundation Trust - Wezham Park and Heatherwood Hospitals

    Slough, SL2 4HL

Other trials in United Kingdom

Belgium5 sites

  • Imelda Ziekenhuis

    Bonheiden, 2820

  • Az Klina

    Brasschaat, 2930

  • UZA

    Edegem, 2650

  • Jessa Ziekenhuis

    Hasselt, 3500

  • Az Damiaan

    Ostend, 8400

Other trials in Belgium

Poland5 sites

  • Onkology Center

    Bydgoszcz, 85796

  • Szpital Kliniczny Przemienienia Panskiego w Poznaniu

    Poznan, 61848

  • Magodent SP Z O.O.

    Warsaw, 01748

  • Wojskowy Instytut Medyczny, Klinika Onkologii

    Warsaw, 04141

  • Dolnoslaskie Centrum Onkologii

    Wroclaw, 53413

Other trials in Poland

Czechia4 sites

  • Krajská Nemocnice Liberec, A.S., Komplexní Onkologické Centrum

    Liberec, 460 63

  • Fakultni Nemocnice Kralovske Vinohrady (FNKV) - Radioterapeuticka a Onkologicka klinika

    Prague, 100 34

  • Thomayerova Nemocnice, Onkologická Klinika 1. LF UK A TN

    Prague, 140 59

  • Fakultni Nemocnice na Bulovce, Institut of Radiation Oncology

    Prague, 18081

Other trials in Czechia

Netherlands4 sites

  • Amphia Ziekenhuis

    Breda, 4819 EV

  • Deventer Hospital

    Deventer, 7416SE

  • Haaglanden Medical Centre

    Leidschendam, 2262 BA

  • Franciscus Gasthuis Hospital

    Rotterdam, 3118 JH

Other trials in Netherlands

Austria2 sites

  • Kepler University Hospital - Urology

    Linz, 4020

  • Universitatsklinikum fur Urologie und Andrologie

    Salzburg, 5020

Other trials in Austria

About this study

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

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.

Read the 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).

Being tested
Data collection
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Data collectionOther

    Only available evaluations as decided by the investigator based on local clinical practice will be collected.

Study groups in NCT03419572
Study groupRoleWhat they receive
Second line therapyData collection
Receives: Other: Data collection
Third and later line therapyData collection
Receives: Other: Data collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of subjects with dose modifications due to AEs

    Measured: 12 months

Secondary outcomes (15)

  1. 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

    Measured: 12 months

  2. Description of number of cabozantinib dose modifications (any modification, reduction, temporary interruption, increase or discontinuation)

    Measured: 12 months

  3. Median time to first cabozantinib dose modification (any modification, reduction, temporary interruption, increase or discontinuation) due to AEs and for any reason

    Measured: 12 months

  4. Description of cabozantinib starting dose (combination of dose per intake and frequency)

    Measured: 12 months

  5. Description of daily dose of cabozantinib received

    Measured: 12 months

  6. Description of cabozantinib dose intensity (average daily dose compared to starting dose)

    Measured: 12 months

  7. Duration of cabozantinib treatment (expressed as mean and median time to end of treatment)

    Measured: 12 months

  8. Proportion of subjects with concomitant radiotherapies

    Measured: 12 months

  9. 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)

    Measured: 12 months

  10. Overall best response

    Per investigator assessment

    Measured: 12 months

  11. 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)

    Measured: 12 months

  12. Overall Survival (OS) rate at the end of the study

    Measured: 12 months

  13. 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

    Measured: 12 months

  14. Health care resource utilisation: Description of concomitant medications (by drug class and preferred name) associated with the management of treatment-related AEs

    Measured: 12 months

  15. Health care resource utilisation: Description of number of unplanned laboratory tests associated with the management of treatment-related AEs

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2018
  2. Study start24 Apr 2018
  3. Primary completion19 May 2022
  4. Study completion19 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
689 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03419572
Sponsor's protocol ID
F-FR-60000-001
Other IDs
EUPAS19464
Acronym
CASSIOPE
Status last verified
Aug 2022
First submitted
15 Dec 2017
Last updated
15 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Renal Cell Carcinoma, run by Ipsen at 91 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in Spain, France, Italy, Germany, Greece and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of subjects with dose modifications due to AEs (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03419572.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022.

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