Spanish Real-World Evidence Cabozantinib (SRWEC)

October 25, 2022 updated by: Spanish Oncology Genito-Urinary Group

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.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
275

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08036
        • Hospital Clínic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Burgos, Spain, 09006
        • Hospital Universitario de Burgos
      • Castellón De La Plana, Spain, 12002
        • Hospital Provincial de Castellon
      • Ciudad Real, Spain, 13005
        • Hospital General de Ciudad Real
      • Cáceres, Spain, 10003
        • Hospital San Pedro De Alcantara
      • Lugo, Spain, 27003
        • Hospital Universitario Lucus Augusti
      • Toledo, Spain, 45004
        • Hospital Virgen de la Salud
      • Valencia, Spain, 46009
        • Fundación Instituto Valenciano de Oncología
      • Valencia, Spain, 46015
        • Hospital Arnau de Vilanova
      • Vigo, Spain, 36312
        • Hospital Universitario Álvaro Cunqueiro
    • Andalucía
      • Córdoba, Andalucía, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Huelva, Andalucía, Spain, 21005
        • Hospital Universitario Juan Ramon Jimenez
      • Jaén, Andalucía, Spain, 23007
        • Complejo Hospitalario de Jaen
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Hospital Universitari Parc Tauli
    • Castilla Y León
      • León, Castilla Y León, Spain, 24008
        • Hospital Universitario de Leon
    • Catalonia
      • Barcelona, Catalonia, Spain, 08041
        • Hospital de la Santa Creu i Sant Pau
    • Catalunya
      • Reus, Catalunya, Spain, 43204
        • Hospital Universitari Sant Joan de Reus
      • Sabadell, Catalunya, Spain, 08208
        • Consorci Corporació Sanitària Parc Taulí de Sabadell
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
    • Comunitat Valenciana
      • Valencia, Comunitat Valenciana, Spain, 46010
        • Hospital Clínico Universitario de Valenica
      • Valencia, Comunitat Valenciana, Spain, 46017
        • Hospital Universitari Dr. Peset
    • Extremadura
      • Badajoz, Extremadura, Spain, 06080
        • Hospital Universitario de Badajoz
    • Galicia
      • A Coruña, Galicia, Spain, 15009
        • Centro Oncologico de Galicia
      • Ferrol, Galicia, Spain, 15405
        • Complejo Hospitalario Universitario de Ferrol
      • Ourense, Galicia, Spain, 32005
        • Complejo Hospitalario Universitario Ourense
    • Illes Ballears
      • Palma De Mallorca, Illes Ballears, Spain, 07120
        • Hospital Universitari Son Espases
    • Islas Baleares
      • Palma De Mallorca, Islas Baleares, Spain, 07198
        • Hospital Son Llàtzer
    • Islas Canarias
      • Las Palmas De Gran Canaria, Islas Canarias, Spain, 35010
        • Hospital Unviersitario de Gran Canaria Doctor Negrin
      • Santa Cruz De Tenerife, Islas Canarias, Spain, 38010
        • Hospital Universitario Nuestra Señora de Candelaria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 2 years
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.
Through study completion, an average of 2 years
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.
Through study completion, an average of 2 years
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.
Through study completion, an average of 2 years
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.
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Spanish Oncology Genito-Urinary Group

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ipsen
Syntax for Science, S.L

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cristina Suárez, MD, Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 23, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SOGUG-2017-A-IEC(REN)-7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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