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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | 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 | 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 |
| 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 | |
| Number of subjects with permanent discontinuations | during the whole study period for a maximum of 28 to 31 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival of subjects since cabozantinib initiation | during the whole study period for a maximum of 28 to 31 months | |
| Overall survival of subjects since RCC diagnosis. | during the whole study period for a maximum of 28 to 31 months |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ipsen Central Contact | Paris | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33253997 | Derived | 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. |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Overall survival of subjects since metastatic diagnosis | during the whole study period for a maximum of 28 to 31 months |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |