Clinical trial NCT03744585: Cabozantinib Real-life Use for Advanced Renal Cell Carcinoma in France: a Retrospective Descriptive Non-interventional Study of 2 Cohorts.
Official title: Cabozantinib Real-life Use for Advanced Renal Cell Carcinoma in France: a Retrospective Descriptive Non-interventional Study of 2 Cohorts.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2018-11-16
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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.


Eligibility 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.

Primary outcomes:
measure: Duration of treatment exposure
timeFrame: during the whole study period for a maximum of 28 to 31 months
measure: Dose prescribed at initiation
timeFrame: during the whole study period for a maximum of 28 to 31 months
measure: Average Daily Dose
timeFrame: during the whole study period for a maximum of 28 to 31 months
measure: Number of subjects with ≥1 temporary interruptions
timeFrame: during the whole study period for a maximum of 28 to 31 months
measure: Number of interruptions per subject
timeFrame: during the whole study period for a maximum of 28 to 31 months
measure: Number of subjects with ≥1 dose modification(s)
timeFrame: during the whole study period for a maximum of 28 to 31 months
measure: Number of subjects with permanent discontinuations
timeFrame: during the whole study period for a maximum of 28 to 31 months
Secondary outcomes:
measure: Overall survival of subjects since cabozantinib initiation
timeFrame: during the whole study period for a maximum of 28 to 31 months
measure: Overall survival of subjects since RCC diagnosis.
timeFrame: during the whole study period for a maximum of 28 to 31 months
measure: Overall survival of subjects since metastatic diagnosis
timeFrame: during the whole study period for a maximum of 28 to 31 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Ipsen Central Contact
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: Albiges L, Flechon A, Chevreau C, Topart D, Gravis G, Oudard S, Tourani JM, Geoffrois L, Meriaux E, Thiery-Vuillemin A, Barthelemy P, Ladoire S, Laguerre B, Perrot V, Billard A, Escudier B, Gross-Goupil M. Real-world evidence of cabozantinib in patients with metastatic renal cell carcinoma: Results from the CABOREAL Early Access Program. Eur J Cancer. 2021 Jan;142:102-111. doi: 10.1016/j.ejca.2020.09.030. Epub 2020 Nov 27.