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

Renal Cell Carcinoma Clinical Trial

— CABOREAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03744585
• Other study ID #: A-FR-60000-006
• Status: Completed
• Start date: November 6, 2018
• Est. completion date: July 7, 2019

Study information

• Verified date: July 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: July 7, 2019
• Est. primary completion date: June 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Locations

Country	Name	City	State
France	Ipsen Central Contact	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of treatment exposure		during the whole study period for a maximum of 28 to 31 months
Primary	Dose prescribed at initiation		during the whole study period for a maximum of 28 to 31 months
Primary	Average Daily Dose	average daily dose received by subject during the treatment exposure	during the whole study period for a maximum of 28 to 31 months
Primary	Number of subjects with =1 temporary interruptions		during the whole study period for a maximum of 28 to 31 months
Primary	Number of interruptions per subject		during the whole study period for a maximum of 28 to 31 months
Primary	Number of subjects with =1 dose modification(s)		during the whole study period for a maximum of 28 to 31 months
Primary	Number of subjects with permanent discontinuations		during the whole study period for a maximum of 28 to 31 months
Secondary	Overall survival of subjects since cabozantinib initiation		during the whole study period for a maximum of 28 to 31 months
Secondary	Overall survival of subjects since RCC diagnosis.		during the whole study period for a maximum of 28 to 31 months
Secondary	Overall survival of subjects since metastatic diagnosis		during the whole study period for a maximum of 28 to 31 months