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

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ClinicalTrials.gov Identifier: NCT03744585
Recruitment Status : Completed
First Posted : November 16, 2018
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Description
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Brief Summary:
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.

Condition or disease
Renal Cell Carcinoma

Study Design
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Study Type : Observational
Actual Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cabozantinib Real-life Use for Advanced Renal Cell Carcinoma in France: a Retrospective Descriptive Non-interventional Study of 2 Cohorts.
Actual Study Start Date : November 6, 2018
Actual Primary Completion Date : June 7, 2019
Actual Study Completion Date : July 7, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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).


Outcome Measures
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Primary Outcome Measures :
  1. Duration of treatment exposure [ Time Frame: during the whole study period for a maximum of 28 to 31 months ]
  2. Dose prescribed at initiation [ Time Frame: during the whole study period for a maximum of 28 to 31 months ]
  3. 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

  4. Number of subjects with ≥1 temporary interruptions [ Time Frame: during the whole study period for a maximum of 28 to 31 months ]
  5. Number of interruptions per subject [ Time Frame: during the whole study period for a maximum of 28 to 31 months ]
  6. Number of subjects with ≥1 dose modification(s) [ Time Frame: during the whole study period for a maximum of 28 to 31 months ]
  7. Number of subjects with permanent discontinuations [ Time Frame: during the whole study period for a maximum of 28 to 31 months ]

Secondary Outcome Measures :
  1. Overall survival of subjects since cabozantinib initiation [ Time Frame: during the whole study period for a maximum of 28 to 31 months ]
  2. Overall survival of subjects since RCC diagnosis. [ Time Frame: during the whole study period for a maximum of 28 to 31 months ]
  3. Overall survival of subjects since metastatic diagnosis [ Time Frame: during the whole study period for a maximum of 28 to 31 months ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03744585


Locations
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France
Ipsen Central Contact
Paris, France
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03744585    
Other Study ID Numbers: A-FR-60000-006
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases