Renal Cell CarcinomaSRWECNCT04510688
Spanish Real-World Evidence Cabozantinib
An observational study of Renal Cell Carcinoma, run by Spanish Oncology Genito-Urinary Group at 32 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Cabozantinib
- How many people
- 275 participants
- Where
- 32 sitesSpain
- Study dates
- 23 Oct 2019to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Data from patients with Renal Cell Carcinoma (RCC) currently under tretament at the study site or data from deceased patients with RCC
Who may be able to join
- 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).
Who cannot join
- Patients who decline consent.
- Patients whose hospital medical records are unavailable for review.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Spain32 sites
Centro Oncológico de Galicia
A Coruña, Galicia, 15009
Hospital Universitario de Badajoz
Badajoz, Extremadura, 06080
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041
Hospital Del Mar
Barcelona, 08003
Hospital Universitari Vall D'Hebron
Barcelona, 08035
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital Universitario de Burgos
Burgos, 09006
Hospital San Pedro de Alcántara
Cáceres, 10003
Hospital Provincial de Castellón
Castellon, 12002
Hospital General de Ciudad Real
Ciudad Real, 13005
Hospital Universitario Reina Sofía
Córdoba, Andalusia, 14004
Complejo Hospitalario Universitario de Ferrol
Ferrol, Galicia, 15405
Hospital Universitario Juan Ramón Jiménez
Huelva, Andalusia, 21005
Complejo Hospitalario de Jaén
Jaén, Andalusia, 23007
Hospital Unviersitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, Canary Islands, 35010
Hospital Universitario de León
León, Castille and León, 24008
Hospital Universitario Lucus Augusti
Lugo, 27003
Complejo Hospitalario Universitario Ourense
Ourense, Galicia, 32005
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, 07198
Hospital Universitari Son Espases
Palma de Mallorca, Illes Ballears, 07120
Hospital Universitari Sant Joan de Reus
Reus, Catalonia, 43204
Hospital Universitari Parc Taulí
Sabadell, Barcelona, 08208
Consorci Corporació Sanitària Parc Taulí de Sabadell
Sabadell, Catalonia, 08208
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Canary Islands, 38010
Hospital Virgen de La Salud
Toledo, 45004
Hospital Clínico Universitario de Valenica
Valencia, Valencia, 46010
Hospital Universitari Dr. Peset
Valencia, Valencia, 46017
Hospital Universitari i Politècnic La Fe
Valencia, Valencia, 46026
Fundación Instituto Valenciano de Oncología
Valencia, 46009
Hospital Arnau de Vilanova
Valencia, 46015
Hospital Universitario Alvaro Cunqueiro
Vigo, 36312
About this study
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
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.
Read more
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
- Being tested
- Cabozantinib
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabozantinibDrug
Observation of treatment with Cabozantinib
| Study group | Role | What they receive |
|---|---|---|
| Managed Access Program (MAP) patients | Patients with RCC treated with cabozantinib under a Managed Access Program (MAP) prior to Cabometyx® marketing authorization Receives: 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 Receives: Drug: Cabozantinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start23 Oct 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Oncology Genito-Urinary Group
- Sponsor type
- University, hospital or other
- Collaborators
- Syntax for Science, S.L, Ipsen
- Responsible party
- Sponsor
- Investigators
- Cristina Suárez, MD, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510688
- Sponsor's protocol ID
- SOGUG-2017-A-IEC(REN)-7
- Acronym
- SRWEC
- Status last verified
- Oct 2022
- First submitted
- 29 Jun 2020
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04510688
- Acronym / sponsor ID
- SRWEC / SOGUG-2017-A-IEC(REN)-7
- Conditions
- Renal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Spanish Oncology Genito-Urinary GroupUniversity, hospital or other
- Collaborators
- Syntax for Science, S.L, Ipsen
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]).
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Managed Access Program (MAP) patients | – | Drug: CabozantinibPatients with RCC treated with cabozantinib under a Managed Access Program (MAP) prior to Cabometyx® marketing authorization |
| Real World (RW) patients | – | Drug: CabozantinibPatients with RCC treated with cabozantinib as routine clinical prescription (Real World), with treatment started after Cabometyx® marketing authorization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data from patients with Renal Cell Carcinoma (RCC) currently under tretament at the study site or data from deceased patients with RCC
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- Patients who decline consent.
- Patients whose hospital medical records are unavailable for review.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CabozantinibObservation of treatment with Cabozantinib | Drug | Managed Access Program (MAP) patients, Real World (RW) patients |
Primary outcome
Effectiveness: Progression-Free Survival
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Renal Cell Carcinoma
RecruitingObservational study
Genetic Analysis of Birt Hogg-Dube Syndrome and Characterization of Predisposition to Kidney Cancer
Kidney Neoplasms, Kidney Cancer
Active, not recruitingPhase 1/2
Study of ST-1898 in Advanced Renal Cell Carcinoma
Advanced Renal Cell Carcinoma
Active, not recruitingPhase 1/2
Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingObservational study
Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease
Malignant Neoplasms, Hereditary Neoplastic Syndromes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina Suárez, MD principal investigator
Investigator
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma, run by Spanish Oncology Genito-Urinary Group at 32 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness: Progression-Free Survival (time frame: Through study completion, an average of 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.