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

Ipsen

Status: Completed

Conditions: Renal Cell Carcinoma

Study type: Observational

Funder types: Industry

Identifiers

NCT03744585

A-FR-60000-006

Details and patient eligibility

About

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.

Enrollment: 450 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

450 participants in 2 patient groups

Cohort 1

Description:

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

Description:

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).