Spanish Real-World Evidence Cabozantinib

NCT04510688 | Completed

• 1 other identifier: SOGUG-2017-A-IEC(REN)-7
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 32

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

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Managed Access Program (MAP) patients

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

Drug: Cabozantinib

Real World (RW) patients

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

Drug: Cabozantinib

Interventions

Cabozantinib DRUG

Observation of treatment with Cabozantinib

Managed Access Program (MAP) patients; Real World (RW) patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Data from patients with Renal Cell Carcinoma (RCC) currently under tretament at the study site or data from deceased patients with RCC

You may qualify if:

• 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).

You may not qualify if:

• Patients who decline consent.
• Patients whose hospital medical records are unavailable for review.

Sponsors & Collaborators

• Spanish Oncology Genito-Urinary Group: lead
• Syntax for Science, S.L: collaborator
• Ipsen: collaborator

Study Sites (32)

Hospital Universitario Reina Sofía

Córdoba, Andalusia, 14004, Spain

Location

Hospital Universitario Juan Ramón Jiménez

Huelva, Andalusia, 21005, Spain

Location

Complejo Hospitalario de Jaén

Jaén, Andalusia, 23007, Spain

Location

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

Hospital Universitari Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital Unviersitario de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, Canary Islands, 35010, Spain

Location

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Canary Islands, 38010, Spain

Location

Hospital Universitario de León

León, Castille and León, 24008, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08041, Spain

Location

Hospital Universitari Sant Joan de Reus

Reus, Catalonia, 43204, Spain

Location

Consorci Corporació Sanitària Parc Taulí de Sabadell

Sabadell, Catalonia, 08208, Spain

Location

Hospital Universitario de Badajoz

Badajoz, Extremadura, 06080, Spain

Location

Centro Oncológico de Galicia

A Coruña, Galicia, 15009, Spain

Location

Complejo Hospitalario Universitario de Ferrol

Ferrol, Galicia, 15405, Spain

Location

Complejo Hospitalario Universitario Ourense

Ourense, Galicia, 32005, Spain

Location

Hospital Universitari Son Espases

Palma de Mallorca, Illes Ballears, 07120, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital Clínico Universitario de Valenica

Valencia, Valencia, 46010, Spain

Location

Hospital Universitari Dr. Peset

Valencia, Valencia, 46017, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, Valencia, 46026, Spain

Location

Hospital Del Mar

Barcelona, 08003, Spain

Location

Hospital Universitari Vall D'Hebron

Barcelona, 08035, Spain

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario de Burgos

Burgos, 09006, Spain

Location

Hospital Provincial de Castellón

Castellon, 12002, Spain

Location

Hospital San Pedro de Alcántara

Cáceres, 10003, Spain

Location

Hospital General de Ciudad Real

Ciudad Real, 13005, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, 27003, Spain

Location

Hospital Virgen de La Salud

Toledo, 45004, Spain

Location

Fundación Instituto Valenciano de Oncología

Valencia, 46009, Spain

Location

Hospital Arnau de Vilanova

Valencia, 46015, Spain

Location

Hospital Universitario Alvaro Cunqueiro

Vigo, 36312, Spain

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

cabozantinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Cristina Suárez, MD

  Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: August 12, 2020
• Study Start: October 23, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (32)