Spanish Real-World Evidence Cabozantinib

Renal Cell Carcinoma Clinical Trial

— SRWEC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04510688
• Other study ID #: SOGUG-2017-A-IEC(REN)-7
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

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