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This is a Norwegian prospective registration, observational study of patients with advanced renal cell cancer on Afinitor treatment after failure of one Tyrosine Kinase Inhibitor (TKI) ( e.g. sunitinib or sorafenib). The goal is to document the treatment algorithm of these patients in Norway and the efficacy and tolerability of Afinitor® in a pure 2.line setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Afinitor | Afinitor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| everolimis | Other |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression (TTP) | maximum of 12 months after inclusion of the last patient |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment algorithm | Follow up documentation | at end of study |
| Quality of life (QoL)(EORTC-QLQ C30) | Follow up documentation | maximum of 12 months after inclusion of the last patient |
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Inclusion Criteria:
Exclusion Criteria:
None
Other protocol-defined inclusion/exclusion criteria may apply
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Patients with advanced renal cell cancer whose disease has progressed on or after one VEGF-TKI therapy
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Kristiansand | 4615 | Norway | |||
| Novartis Investigative Site |
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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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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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None Retained
| Tolerability | This will partly be assessed by registration of compliance (patient booklet), QoL and safety. Safety assessments will consist of monitoring and recording adverse events and serious adverse events. | maximum of 12 months after inclusion of the last patient |
| Tromsø |
| 9038 |
| Norway |
| Novartis Investigative Site | Trondheim | 7006 | Norway |
| 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 |