SRWEC: Spanish Real-World Evidence Cabozantinib

Sponsor

Spanish Oncology Genito-Urinary Group (Other)

Overall Status

Recruiting

CT.gov ID

NCT04510688

Collaborator

Syntax for Science, S.L (Industry), Ipsen (Industry)

300

Enrollment

Locations

33.2

Anticipated Duration (Months)

9.4

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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]).

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Carcinoma	Drug: Cabozantinib

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Case-Only

Time Perspective:

Other

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

Actual Study Start Date :

Oct 23, 2019

Anticipated Primary Completion Date :

Mar 31, 2022

Anticipated Study Completion Date :

Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Managed Access Program (MAP) patients Patients with RCC treated with cabozantinib under a Managed Access Program (MAP) prior to Cabometyx® marketing authorization	Drug: Cabozantinib 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	Drug: Cabozantinib Observation of treatment with Cabozantinib

Arm

Intervention/Treatment

Managed Access Program (MAP) patients

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

Drug: Cabozantinib

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

Drug: Cabozantinib

Observation of treatment with Cabozantinib

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Reina Sofía	Córdoba	Andalucía	Spain	14004
2	Hospital Universitario Juan Ramón Jiménez	Huelva	Andalucía	Spain	21005
3	Complejo Hospitalario de Jaén	Jaén	Andalucía	Spain	23007
4	Hospital Universitario Central de Asturias	Oviedo	Asturias	Spain	33011
5	Hospital Universitari Parc Taulí	Sabadell	Barcelona	Spain	08208
6	Hospital Universitario de León	León	Castilla Y León	Spain	24008
7	Hospital de la Santa Creu i Sant Pau	Barcelona	Catalonia	Spain	08041
8	Hospital Universitari Sant Joan de Reus	Reus	Catalunya	Spain	43204
9	Consorci Corporació Sanitària Parc Taulí de Sabadell	Sabadell	Catalunya	Spain	08208
10	Hospital Universitari i Politècnic La Fe	Valencia	Comunidad Valenciana	Spain	46026
11	Hospital Clínico Universitario de Valenica	Valencia	Comunitat Valenciana	Spain	46010
12	Hospital Universitari Dr. Peset	Valencia	Comunitat Valenciana	Spain	46017
13	Hospital Universitario de Badajoz	Badajoz	Extremadura	Spain	06080
14	Centro Oncológico de Galicia	A Coruña	Galicia	Spain	15009
15	Complejo Hospitalario Universitario de Ferrol	Ferrol	Galicia	Spain	15405
16	Complejo Hospitalario Universitario Ourense	Ourense	Galicia	Spain	32005
17	Hospital Universitari Son Espases	Palma De Mallorca	Illes Ballears	Spain	07120
18	Hospital Son Llatzer	Palma De Mallorca	Islas Baleares	Spain	07198
19	Hospital Unviersitario de Gran Canaria Doctor Negrin	Las Palmas De Gran Canaria	Islas Canarias	Spain	35010
20	Hospital Universitario Nuestra Señora de Candelaria	Santa Cruz De Tenerife	Islas Canarias	Spain	38010
21	Hospital Del Mar	Barcelona		Spain	08003
22	Hospital Universitari Vall D'Hebron	Barcelona		Spain	08035
23	Hospital Clínic de Barcelona	Barcelona		Spain	08036
24	Hospital Universitario de Burgos	Burgos		Spain	09006
25	Hospital Provincial de Castellón	Castellón De La Plana		Spain	12002
26	Hospital General de Ciudad Real	Ciudad Real		Spain	13005
27	Hospital San Pedro de Alcántara	Cáceres		Spain	10003
28	Hospital Universitario Lucus Augusti	Lugo		Spain	27003
29	Hospital Virgen de La Salud	Toledo		Spain	45004
30	Fundación Instituto Valenciano de Oncología	Valencia		Spain	46009
31	Hospital Arnau de Vilanova	Valencia		Spain	46015
32	Hospital Universitario Alvaro Cunqueiro	Vigo		Spain	36312

Sponsors and Collaborators

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

Investigators

Principal Investigator: Cristina Suárez, MD, Investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Spanish Oncology Genito-Urinary Group

ClinicalTrials.gov Identifier:

NCT04510688

Other Study ID Numbers:

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

First Posted:

Aug 12, 2020

Last Update Posted:

Sep 22, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Renal Cell

Study Results

No Results Posted as of Sep 22, 2021