Spanish Real-World Evidence Cabozantinib

NCT ID: NCT04510688

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 275 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-23
• Study Completion Date: 2022-06-30

Brief 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]).

Conditions

Renal Cell Carcinoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Study Groups

Managed Access Program (MAP) patients

Patients with RCC treated with cabozantinib under a Managed Access Program (MAP) prior to Cabometyx® marketing authorization

Cabozantinib

Intervention Type: DRUG

Observation of treatment with Cabozantinib

Real World (RW) patients

Patients with RCC treated with cabozantinib as routine clinical prescription (Real World), with treatment started after Cabometyx® marketing authorization

Cabozantinib

Intervention Type: DRUG

Observation of treatment with Cabozantinib

Interventions

Cabozantinib

Observation of treatment with Cabozantinib

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Syntax for Science, S.L

INDUSTRY

Sponsor Role: collaborator

Ipsen

INDUSTRY

Sponsor Role: collaborator

Spanish Oncology Genito-Urinary Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cristina Suárez, MD

Role: PRINCIPAL_INVESTIGATOR

Investigator

Locations

Hospital Universitario Reina Sofía

Córdoba, Andalusia, Spain

Hospital Universitario Juan Ramón Jiménez

Huelva, Andalusia, Spain

Complejo Hospitalario de Jaén

Jaén, Andalusia, Spain

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, Spain

Hospital Universitari Parc Taulí

Sabadell, Barcelona, Spain

Hospital Unviersitario de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, Canary Islands, Spain

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Canary Islands, Spain

Hospital Universitario de León

León, Castille and León, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Hospital Universitari Sant Joan de Reus

Reus, Catalonia, Spain

Consorci Corporació Sanitària Parc Taulí de Sabadell

Sabadell, Catalonia, Spain

Hospital Universitario de Badajoz

Badajoz, Extremadura, Spain

Centro Oncológico de Galicia

A Coruña, Galicia, Spain

Complejo Hospitalario Universitario de Ferrol

Ferrol, Galicia, Spain

Complejo Hospitalario Universitario Ourense

Ourense, Galicia, Spain

Hospital Universitari Son Espases

Palma de Mallorca, Illes Ballears, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Hospital Clínico Universitario de Valenica

Valencia, Valencia, Spain

Hospital Universitari Dr. Peset

Valencia, Valencia, Spain

Hospital Universitari i Politècnic La Fe

Valencia, Valencia, Spain

Hospital Del Mar

Barcelona, , Spain

Hospital Universitari Vall D'Hebron

Barcelona, , Spain

Hospital Clínic de Barcelona

Barcelona, , Spain

Hospital Universitario de Burgos

Burgos, , Spain

Hospital Provincial de Castellón

Castellon, , Spain

Hospital San Pedro de Alcántara

Cáceres, , Spain

Hospital General de Ciudad Real

Ciudad Real, , Spain

Hospital Universitario Lucus Augusti

Lugo, , Spain

Hospital Virgen de La Salud

Toledo, , Spain

Fundación Instituto Valenciano de Oncología

Valencia, , Spain

Hospital Arnau de Vilanova

Valencia, , Spain

Hospital Universitario Alvaro Cunqueiro

Vigo, , Spain

Countries

Spain

Other Identifiers

SOGUG-2017-A-IEC(REN)-7

Identifier Type: -

Identifier Source: org_study_id