A Norwegian Observational Trial Evaluating the Treatment of Advanced Renal Cell Cancer Patients Under Treatment of Afinitor
Completed
- Conditions
- Metastatic Renal Cell Carcinoma (mRCC)
- Interventions
- Other: everolimis
- Registration Number
- NCT01390519
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Age > 18 years
- Confirmed diagnosis of advanced renal cell cancer
- Progression on or after one VEGF -TKI (e.g. sunitibin, sorafenib)
- Written informed consent
Exclusion Criteria
None
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Afinitor everolimis Afinitor
- Primary Outcome Measures
Name Time Method Time to progression (TTP) maximum of 12 months after inclusion of the last patient
- Secondary Outcome Measures
Name Time Method Treatment algorithm at end of study Follow up documentation
Quality of life (QoL)(EORTC-QLQ C30) maximum of 12 months after inclusion of the last patient Follow up documentation
Tolerability maximum of 12 months after inclusion of the last patient 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.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇳🇴Trondheim, Norway