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

NCT ID: NCT03419572

Last Updated: 2022-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

689 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-24

Study Completion Date

2022-05-19

Brief Summary

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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

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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).

Conditions

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Renal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Second line therapy

Data collection

Data collection

Intervention Type OTHER

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

Third and later line therapy

Data collection

Data collection

Intervention Type OTHER

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

Interventions

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Data collection

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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Kepler University Hospital - Urology

Linz, , Austria

Site Status

Universitatsklinikum fur Urologie und Andrologie

Salzburg, , Austria

Site Status

Imelda Ziekenhuis

Bonheiden, , Belgium

Site Status

Az Klina

Brasschaat, , Belgium

Site Status

UZA

Edegem, , Belgium

Site Status

Jessa Ziekenhuis

Hasselt, , Belgium

Site Status

Az Damiaan

Ostend, , Belgium

Site Status

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

Liberec, , Czechia

Site Status

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

Prague, , Czechia

Site Status

Thomayerova Nemocnice, Onkologická Klinika 1. LF UK A TN

Prague, , Czechia

Site Status

Fakultni Nemocnice na Bulovce, Institut of Radiation Oncology

Prague, , Czechia

Site Status

CHU Angers

Angers, , France

Site Status

CH Cote Basque

Bayonne, , France

Site Status

Centre Hospitalier Universitaire

Besançon, , France

Site Status

Hopital Saint Andre - CHU de Bordeaux

Bordeaux, , France

Site Status

Centre Catalan d'Urologie

Cabestany, , France

Site Status

Centre Maurice Tubiana

Caen, , France

Site Status

CHU Henri Mondor

Créteil, , France

Site Status

Grenoble University Hospital

Grenoble, , France

Site Status

Polyclinique Chénieux

Limoges, , France

Site Status

L'institut Mutualiste Montsouris

Paris, , France

Site Status

Hospital De Cornouaille

Quimper, , France

Site Status

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

Reims, , France

Site Status

Institut de Cancérologie Lucien Neuwirth (ICLN)

Saint-Priest-en-Jarez, , France

Site Status

Strasbourg Oncologie Liberale

Strasbourg, , France

Site Status

Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status

CHU Tours - Hopital Bretonneau

Tours, , France

Site Status

Vivantes Klinikum Neukolln

Berlin, , Germany

Site Status

MVZ- Polyclinic Eisenach

Eisenach, , Germany

Site Status

Universitaetsklinikum Frankfurt - Department of Urology

Frankfurt, , Germany

Site Status

University Medical Center Halle (Saale)

Halle, , Germany

Site Status

University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Asklepios Clinic Altona Hamburg

Hamburg, , Germany

Site Status

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

München, , Germany

Site Status

Universitätsklinikum Münster

Münster, , Germany

Site Status

MVP MP Saaletal Saalfeld/Saale

Saalfeld, , Germany

Site Status

Dept of Urology, Eberhard-Karls-University Tuebingen

Tübingen, , Germany

Site Status

University Medical Center Ulm

Ulm, , Germany

Site Status

Evaggelismos Hospital

Athens, , Greece

Site Status

Saint Savvas Hospital

Athens, , Greece

Site Status

Alexandra Hospital

Athens, , Greece

Site Status

G.O.H.K "Oi Agioi Anargiroi"

Athens, , Greece

Site Status

Dep. Medical Oncology, University Hospital of Ioannina

Ioannina, , Greece

Site Status

Papageorgiou Hospital

Thessaloniki, , Greece

Site Status

Interbalkan Medical Center

Thessaloniki, , Greece

Site Status

Azienda Ospedaliera S.Orsola Malpighi di Bologna

Bologna, , Italy

Site Status

Fondazione IRCCS Istituto Nazionale Dei Tumori

Milan, , Italy

Site Status

Azienda Ospedaliero Universitaria di Modena

Modena, , Italy

Site Status

Aorn Cardarelli

Napoli, , Italy

Site Status

National Cancer Institute "Fondazione G. Pascale" IRCCS

Napoli, , Italy

Site Status

Umberto Basso

Padua, , Italy

Site Status

Azienda Ospedaliero-Universitaria di Parma

Parma, , Italy

Site Status

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

Pavia, , Italy

Site Status

IRCCS Azienda Usl Di Reggio Emilia

Reggio Emilia, , Italy

Site Status

Gemelli Hospital

Roma, , Italy

Site Status

UOC Oncologia Azienda Ospedaliera Sant-Andrea

Rome, , Italy

Site Status

Presidio Ospedaliero Santa Chiara

Trento, , Italy

Site Status

Azienda Ospedaliera Universitaria Integrata Verona

Verona, , Italy

Site Status

San Bortolo General Hospital

Vicenza, , Italy

Site Status

Amphia Ziekenhuis

Breda, , Netherlands

Site Status

Deventer Hospital

Deventer, , Netherlands

Site Status

Haaglanden Medical Centre

Leidschendam, , Netherlands

Site Status

Franciscus Gasthuis Hospital

Rotterdam, , Netherlands

Site Status

Onkology Center

Bydgoszcz, , Poland

Site Status

Szpital Kliniczny Przemienienia Panskiego w Poznaniu

Poznan, , Poland

Site Status

Magodent SP Z O.O.

Warsaw, , Poland

Site Status

Wojskowy Instytut Medyczny, Klinika Onkologii

Warsaw, , Poland

Site Status

Dolnoslaskie Centrum Onkologii

Wroclaw, , Poland

Site Status

Hospital Vall de Hebron

Barcelona, , Spain

Site Status

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status

Hospital De La Santa Creu I Sant Pau

Barcelona, , Spain

Site Status

Hospital Dr. Josep Trueta

Girona, , Spain

Site Status

Hospital Universitario de León

León, , Spain

Site Status

Hospital Universitario Lucus Augusti

Lugo, , Spain

Site Status

Hospital Ramón y Cajal

Madrid, , Spain

Site Status

Hospital 12 de Octubre

Madrid, , Spain

Site Status

Hospital Virgen de la Victoria

Málaga, , Spain

Site Status

Hospital Morales Meseguer

Murcia, , Spain

Site Status

Hospital Universitario Central de Asturias (Huca)

Oviedo, , Spain

Site Status

Hospital Universitario Son Espases

Palma de Mallorca, , Spain

Site Status

Complejo Hospitalario De Navarra

Pamplona, , Spain

Site Status

Hospital Universitari Parc Tauli

Sabadell, , Spain

Site Status

Complejo Hospitalario Universitario de Compostela

Santiago de Compostela, , Spain

Site Status

Hospital Álvaro Cunqueiro de Vigo

Vigo, , Spain

Site Status

Hospital Clinico Lozano Blesa de Zaragoza

Zaragoza, , Spain

Site Status

East Kent Hospitals University NHS Foundation Trust

Canterbury, , United Kingdom

Site Status

Royal Derby Hospital

Derby, , United Kingdom

Site Status

Freeman Hospital-Northern Centre For Cancer Care

Newcastle, , United Kingdom

Site Status

Mount Vernon Cancer Centre - East and North Hertfordshire NHS Trust

Northwood, , United Kingdom

Site Status

Rosemere Cancer Centre, Royal Preston Hospital

Preston, , United Kingdom

Site Status

Frimley Health NHS Foundation Trust - Wezham Park and Heatherwood Hospitals

Slough, , United Kingdom

Site Status

Countries

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Austria Belgium Czechia France Germany Greece Italy Netherlands Poland Spain United Kingdom

Other Identifiers

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EUPAS19464

Identifier Type: REGISTRY

Identifier Source: secondary_id

F-FR-60000-001

Identifier Type: -

Identifier Source: org_study_id

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