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

Completed

• Conditions: Renal Cell Carcinoma

• Registration Number: NCT03744585
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-06
• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-11-14
• Study First Posted: 2018-11-16
• Primary Completion: 2019-06-07
• Status Verified: 2019-07
• Study Completion: 2019-07-07
• Last Update Submitted: 2019-07-24
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ipsen Central Contact; 🇫🇷 Paris, France