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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04510688
Other study ID # SOGUG-2017-A-IEC(REN)-7
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 23, 2019
Est. completion date June 30, 2022

Study information

Verified date October 2022
Source Spanish Oncology Genito-Urinary Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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]).


Recruitment information / eligibility

Status Completed
Enrollment 275
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Male or females, aged 18 years or older. 2. Diagnosis of advanced Renal Cell Carcinoma (RCC) 3. 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. 4. Alive patients who agree to participate and signed the Informed Consent Form (ICF). Exclusion Criteria: 1. Patients who decline consent. 2. Patients whose hospital medical records are unavailable for review.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cabozantinib
Observation of treatment with Cabozantinib

Locations

Country Name City State
Spain Centro Oncológico de Galicia A Coruña Galicia
Spain Hospital Universitario de Badajoz Badajoz Extremadura
Spain Hospital Clínic de Barcelona Barcelona
Spain Hospital de la Santa Creu i Sant Pau Barcelona Catalonia
Spain Hospital Del Mar Barcelona
Spain Hospital Universitari Vall D'Hebron Barcelona
Spain Hospital Universitario de Burgos Burgos
Spain Hospital San Pedro de Alcántara Cáceres
Spain Hospital Provincial de Castellón Castellón De La Plana
Spain Hospital General de Ciudad Real Ciudad Real
Spain Hospital Universitario Reina Sofía Córdoba Andalucía
Spain Complejo Hospitalario Universitario de Ferrol Ferrol Galicia
Spain Hospital Universitario Juan Ramón Jiménez Huelva Andalucía
Spain Complejo Hospitalario de Jaén Jaén Andalucía
Spain Hospital Unviersitario de Gran Canaria Doctor Negrin Las Palmas De Gran Canaria Islas Canarias
Spain Hospital Universitario de León León Castilla Y León
Spain Hospital Universitario Lucus Augusti Lugo
Spain Complejo Hospitalario Universitario Ourense Ourense Galicia
Spain Hospital Universitario Central de Asturias Oviedo Asturias
Spain Hospital Son Llatzer Palma De Mallorca Islas Baleares
Spain Hospital Universitari Son Espases Palma De Mallorca Illes Ballears
Spain Hospital Universitari Sant Joan de Reus Reus Catalunya
Spain Consorci Corporació Sanitària Parc Taulí de Sabadell Sabadell Catalunya
Spain Hospital Universitari Parc Taulí Sabadell Barcelona
Spain Hospital Universitario Nuestra Señora de Candelaria Santa Cruz De Tenerife Islas Canarias
Spain Hospital Virgen de La Salud Toledo
Spain Fundación Instituto Valenciano de Oncología Valencia
Spain Hospital Arnau de Vilanova Valencia
Spain Hospital Clínico Universitario de Valenica Valencia Comunitat Valenciana
Spain Hospital Universitari Dr. Peset Valencia Comunitat Valenciana
Spain Hospital Universitari i Politècnic La Fe Valencia Comunidad Valenciana
Spain Hospital Universitario Alvaro Cunqueiro Vigo

Sponsors (3)

Lead Sponsor Collaborator
Spanish Oncology Genito-Urinary Group Ipsen, Syntax for Science, S.L

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effectiveness: Progression-Free Survival 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 Through study completion, an average of 2 years
Primary Incidence of Adverse Reactions Evaluation of the safety of cabozantinib by recording the incidence of adverse reactions in both MAP and RW cohorts. Through study completion, an average of 2 years
Primary Incidence of dose reductions Evaluation of the safety of cabozantinib by recording the incidence of dose reductions in both MAP and RW cohorts. Through study completion, an average of 2 years
Primary Incidence of temporary interruptions or discontinuations Evaluation of the safety of cabozantinib by recording the Incidence of temporary interruptions or discontinuations in both MAP and RW cohorts. Through study completion, an average of 2 years
Primary Incidence of use of medications to manage adverse reactions Evaluation of the safety of cabozantinib by recording the incidence of use of medications to manage adverse reactions in both MAP and RW cohorts. Through study completion, an average of 2 years
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