Clinical trial · Observational
Cabozantinib Real-life Use for Advanced Renal Cell Carcinoma in France: a Retrospective Descriptive Non-interventional Study of 2 Cohorts.
NCT03744585CI-TRIAL-00039755CABOREALcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- 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).
- label
- 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).
Primary outcomes (7)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDAlbiges 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. PMID 33253997