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The purpose of this study is to describe the real-life use of Cabometyx® in monotherapy or in combination with nivolumab in Belgium in patients with advanced or metastatic Renal Cell Carcinoma (1st, 2nd and later lines of treatment)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1st line | |||
| 2nd line | |||
| later lines |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment line | Treatment line will be assessed at baseline. It is a percentage of patients receiving cabozantinib as 1st, 2nd or later lines of treatment or cabozantinib in monotherapy or in combination with nivolumab as 1st line of treatment. | Baseline |
| Dose reductions and reasons | Number of dose reductions and reason | From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop |
| Treatment interruptions and reason | Number of treatment interruptions and reason | From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop |
| Treatment discontinuations and reason | Number of patients with permanent discontinuation and reason | From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop |
| Alternative dose schedule | Number of patients with schedules other than 1 pill at fixed dose/day for the total treatment period | From baseline until the end of study up to 9 months |
| Mean number of any dose modification | From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop | |
| Median number of any dose modification | From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life score | Changes in quality of life data by comparing changes in scores on Using the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (NFKSI-19). It describes the severity, interference, and frequency rates. | From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop |
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Inclusion Criteria:
Exclusion Criteria:
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advanced or metastatic renal cell carcinoma
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onze-Lieve-vrouw Ziekenhuis Aalst | Aalst | 9300 | Belgium | |||
| Imeldaziekenhuis |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications.
Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
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Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).
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| Median time to any first dose modification | From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop |
| Median time to end of treatment | From baseline until the end of study up to 9 months |
| Duration of treatment exposure | From baseline until the end of study up to 9 months |
| Dose prescribed at initiation | Number of patients with dose of 60 mg/day, 40 mg/day or 20 mg/day at baseline | Baseline |
| Average daily dose | Estimation of average daily dose received by subject during the treatment exposure | From baseline until the end of study up to 9 months |
| Progression Free Survival (PFS) | Radiological progression using RECIST 1.1 or investigator assessed or according to local standard of care or death; PFS evaluated at least every 12 weeks under treatment with cabozantinib | From baseline until the end of study up to 9 months |
| Objective Response Rate | Percent of patients with partial and complete response during the treatment with cabozantinib | From baseline until the end of study up to 9 months |
| Disease Control Rate | Percent of patients with stable disease, partial and complete response during the treatment with cabozantinib | From baseline until the end of study up to 9 months |
| Bonheiden |
| 2820 |
| Belgium |
| Clinique Saint-Luc Bouge | Bouge | 5004 | Belgium |
| AZ Sint-Jan Brugge | Bruges | 8000 | Belgium |
| AZ Sint-Lucas | Bruges | 8310 | Belgium |
| UZ Brussel | Brussels | 1090 | Belgium |
| Ziekenhuis Oost-Limburg Genk | Genk | 3600 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| Hôpital de Jolimont | La Louvière | 7100 | Belgium |
| CHC MontLegia | Liège | 4000 | Belgium |
| CHR Citadelle Liège | Liège | 4000 | Belgium |
| CHU Liège / Sart-Tilman | Liège | 4000 | Belgium |
| Hôpital Ambroise-Paré Mons | Mons | 7000 | Belgium |
| CHU Charleroi - site André Vésale | Montigny-le-Tilleul | 6110 | Belgium |
| Clinique Saint-Pierre | Ottignies | 1340 | Belgium |
| AZ Delta | Roeselare | 8800 | Belgium |
| AZ Glorieux | Ronse | 9600 | Belgium |
| CHWAPI | Tournai | 7500 | Belgium |
| AZ Turnhout | Turnhout | 2300 | Belgium |
| CHR Verviers | Verviers | 4800 | Belgium |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| 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 |
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