- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04510688
Spanish Real-World Evidence Cabozantinib (SRWEC)
Study of the Effectiveness and Safety of Cabozantinib Treatment in Patients With Advanced Renal Cell Carcinoma (RCC) Under a Spanish Managed Access Program and Real-world Practice
RCC (Renal Cell Carcinoma) is the most common form of kidney cancer, accounting for 2-3% of all adult malignancies and for 90% of all kidney cancers. The incidence of RCC has steadily increased over the past two decades, showing a plateau in recent years. Many patients with RCC remain asymptomatic until late disease stages and other patients have disease at diagnosis (metastatic RCC or mRCC).
Recently, the tyrosine kinase inhibitor (TKI) cabozantinib was approved as a first-line therapy for patients with advanced clear-cell RCC (ccRCC). Cabozantinib was initially approved for patients previously treated with antiangiogenic therapy based on the phase 3 METEOR study, which demonstrated a clinical benefit compared with everolimus.
Immunotherapy has been also developed in ccRCC.
The frontline treatment paradigm for ccRCC has evolved, particularly for intermediate-/poor-risk patients, with the recent addition of cabozantinib and nivolumab/ipilimumab (immunotherapy), but overall survival data are needed to understand their benefit-to-risk profiles compared with established therapies.
In October 2016, the Spanish Agency of medicines (AEMPS) granted the temporary Authorization for special use to Cabometyx® 20/40/60 mg within a Managed Access Program (MAP) for the treatment of advanced RCC in adults following prior VEGF-targeted therapy (Vascular Endothelial Growth Factor targeted therapy). The MAP allows the possibility of using a medicinal product which is not yet commercially available or approved. By the end of the MAP period, on July 2017, 136 patients had been included by 61 centers who received at least one dose of Cabometyx® for the treatment of advanced RCC.
Since then, Cabometyx® 20/40/60 mg was made commercially available for the treatment of advanced RCC in adults following prior VEGF-targeted therapy. After the commercialization of Cabometyx® in July 2017 in Spain, the inclusion of new patients in the MAP was closed but those patients that were already included continued receiving Cabometyx® free of charge until clinical decision. In July 2018, the European Commission approved a new indication for adult patients previously untreated with intermediate or poor risk.
Based on this rationale, the aim of this study is to obtain safety and effectiveness information regarding the use of cabozantinib in a non-selected RCC population, both in patients that received this agent under the MAP or under routine clinical prescription (real-world [RW]).
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Barcelona, Spain, 08003
- Hospital Del Mar
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Barcelona, Spain, 08036
- Hospital Clínic de Barcelona
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Barcelona, Spain, 08035
- Hospital Universitari Vall d'Hebron
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Burgos, Spain, 09006
- Hospital Universitario de Burgos
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Castellón De La Plana, Spain, 12002
- Hospital Provincial de Castellón
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Ciudad Real, Spain, 13005
- Hospital General de Ciudad Real
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Cáceres, Spain, 10003
- Hospital San Pedro de Alcántara
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Lugo, Spain, 27003
- Hospital Universitario Lucus Augusti
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Toledo, Spain, 45004
- Hospital Virgen de la Salud
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Valencia, Spain, 46009
- Fundación Instituto Valenciano de Oncología
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Valencia, Spain, 46015
- Hospital Arnau de Vilanova
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Vigo, Spain, 36312
- Hospital Universitario Alvaro Cunqueiro
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Andalucía
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Córdoba, Andalucía, Spain, 14004
- Hospital Universitario Reina Sofia
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Huelva, Andalucía, Spain, 21005
- Hospital Universitario Juan Ramon Jimenez
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Jaén, Andalucía, Spain, 23007
- Complejo Hospitalario de Jaén
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Asturias
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Oviedo, Asturias, Spain, 33011
- Hospital Universitario Central de Asturias
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Barcelona
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Sabadell, Barcelona, Spain, 08208
- Hospital Universitari Parc Tauli
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Castilla Y León
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León, Castilla Y León, Spain, 24008
- Hospital Universitario de Leon
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Catalonia
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Barcelona, Catalonia, Spain, 08041
- Hospital de la Santa Creu i Sant Pau
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Catalunya
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Reus, Catalunya, Spain, 43204
- Hospital Universitari Sant Joan de Reus
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Sabadell, Catalunya, Spain, 08208
- Consorci Corporació Sanitària Parc Taulí de Sabadell
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Comunidad Valenciana
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Valencia, Comunidad Valenciana, Spain, 46026
- Hospital Universitari i Politecnic La Fe
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Comunitat Valenciana
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Valencia, Comunitat Valenciana, Spain, 46010
- Hospital Clínico Universitario de Valenica
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Valencia, Comunitat Valenciana, Spain, 46017
- Hospital Universitari Dr. Peset
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Extremadura
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Badajoz, Extremadura, Spain, 06080
- Hospital Universitario de Badajoz
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Galicia
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A Coruña, Galicia, Spain, 15009
- Centro Oncológico de Galicia
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Ferrol, Galicia, Spain, 15405
- Complejo Hospitalario Universitario de Ferrol
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Ourense, Galicia, Spain, 32005
- Complejo Hospitalario Universitario Ourense
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Illes Ballears
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Palma De Mallorca, Illes Ballears, Spain, 07120
- Hospital Universitari Son Espases
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Islas Baleares
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Palma De Mallorca, Islas Baleares, Spain, 07198
- Hospital Son Llatzer
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Islas Canarias
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Las Palmas De Gran Canaria, Islas Canarias, Spain, 35010
- Hospital Unviersitario de Gran Canaria Doctor Negrin
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Santa Cruz De Tenerife, Islas Canarias, Spain, 38010
- Hospital Universitario Nuestra Señora de Candelaria
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male or females, aged 18 years or older.
- Diagnosis of advanced Renal Cell Carcinoma (RCC)
- Alive or dead patients at study initiation who received at least one dose of cabozantinib for the treatment of RCC between October 2016 and 1 st June 2019.
- Alive patients who agree to participate and signed the Informed Consent Form (ICF).
Exclusion Criteria:
- Patients who decline consent.
- Patients whose hospital medical records are unavailable for review.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Managed Access Program (MAP) patients
Patients with RCC treated with cabozantinib under a Managed Access Program (MAP) prior to Cabometyx® marketing authorization
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Observation of treatment with Cabozantinib
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Real World (RW) patients
Patients with RCC treated with cabozantinib as routine clinical prescription (Real World), with treatment started after Cabometyx® marketing authorization
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Observation of treatment with Cabozantinib
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effectiveness: Progression-Free Survival
Time Frame: Through study completion, an average of 2 years
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Evaluation of the effectiveness of cabozantinib in terms of investigator-assessed PFS (Progression-Free Survival) based on the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
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Through study completion, an average of 2 years
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Incidence of Adverse Reactions
Time Frame: Through study completion, an average of 2 years
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Evaluation of the safety of cabozantinib by recording the incidence of adverse reactions in both MAP and RW cohorts.
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Through study completion, an average of 2 years
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Incidence of dose reductions
Time Frame: Through study completion, an average of 2 years
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Evaluation of the safety of cabozantinib by recording the incidence of dose reductions in both MAP and RW cohorts.
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Through study completion, an average of 2 years
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Incidence of temporary interruptions or discontinuations
Time Frame: Through study completion, an average of 2 years
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Evaluation of the safety of cabozantinib by recording the Incidence of temporary interruptions or discontinuations in both MAP and RW cohorts.
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Through study completion, an average of 2 years
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Incidence of use of medications to manage adverse reactions
Time Frame: Through study completion, an average of 2 years
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Evaluation of the safety of cabozantinib by recording the incidence of use of medications to manage adverse reactions in both MAP and RW cohorts.
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Through study completion, an average of 2 years
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Collaborators and Investigators
Investigators
- Principal Investigator: Cristina Suárez, MD, Investigator
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOGUG-2017-A-IEC(REN)-7
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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