Cabozantinib Real-life Use for Advanced Renal Cell Carcinoma in France: a Retrospective Descriptive Non-interventional Study of 2 Cohorts. (CABOREAL)

July 24, 2019 updated by: Ipsen
The primary objective of the study is to describe the real-life conditions of use and exposure of cabozantinib in France in two cohorts defined by their treatment initiation period.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

450

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

  • France
      • Paris, France
        • Ipsen Central Contact

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cohort 1: subjects who received at least one dose of cabozantinib during the ATU period (12/09/2016 to 09/12/2016) for the treatment of advanced RCC. Cohort 2: subjects who received at least one dose of cabozantinib during the first six months after the ATU period (10/12/2016 to 16/02/2018).

Description

Inclusion Criteria:

  • Any subjects from the participating sites (dead or alive) who have received at least one dose of cabozantinib within the ATU program or between 10/12/2016 and 16/02/2018 and for whom the medical file is available

Exclusion Criteria:

  • Patients alive at study initiation who have not received information notice
  • who have opposed to data collection.

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

Cohorts and Interventions

Group / Cohort
Cohort 1
Subjects who received at least one dose of cabozantinib during the Authorization for Use (ATU) period (12/09/2016 to 09/12/2016) for the treatment of advanced Renal Cell Carcinoma (RCC).
Cohort 2
Subjects who received at least one dose of cabozantinib during the first six months after the ATU period (10/12/2016 to 16/02/2018).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of treatment exposure
Time Frame: during the whole study period for a maximum of 28 to 31 months
during the whole study period for a maximum of 28 to 31 months
Dose prescribed at initiation
Time Frame: during the whole study period for a maximum of 28 to 31 months
during the whole study period for a maximum of 28 to 31 months
Average Daily Dose
Time Frame: during the whole study period for a maximum of 28 to 31 months
average daily dose received by subject during the treatment exposure
during the whole study period for a maximum of 28 to 31 months
Number of subjects with ≥1 temporary interruptions
Time Frame: during the whole study period for a maximum of 28 to 31 months
during the whole study period for a maximum of 28 to 31 months
Number of interruptions per subject
Time Frame: during the whole study period for a maximum of 28 to 31 months
during the whole study period for a maximum of 28 to 31 months
Number of subjects with ≥1 dose modification(s)
Time Frame: during the whole study period for a maximum of 28 to 31 months
during the whole study period for a maximum of 28 to 31 months
Number of subjects with permanent discontinuations
Time Frame: during the whole study period for a maximum of 28 to 31 months
during the whole study period for a maximum of 28 to 31 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival of subjects since cabozantinib initiation
Time Frame: during the whole study period for a maximum of 28 to 31 months
during the whole study period for a maximum of 28 to 31 months
Overall survival of subjects since RCC diagnosis.
Time Frame: during the whole study period for a maximum of 28 to 31 months
during the whole study period for a maximum of 28 to 31 months
Overall survival of subjects since metastatic diagnosis
Time Frame: during the whole study period for a maximum of 28 to 31 months
during the whole study period for a maximum of 28 to 31 months

Collaborators and Investigators

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

Sponsor

Ipsen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 6, 2018

Primary Completion (Actual)

June 7, 2019

Study Completion (Actual)

July 7, 2019

Study Registration Dates

First Submitted

November 14, 2018

First Submitted That Met QC Criteria

November 14, 2018

First Posted (Actual)

November 16, 2018

Study Record Updates

Last Update Posted (Actual)

July 26, 2019

Last Update Submitted That Met QC Criteria

July 24, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-FR-60000-006

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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