A Norwegian Observational Trial Evaluating the Treatment of Advanced Renal Cell Cancer Patients Under Treatment of Afinitor

Completed

• Conditions: Metastatic Renal Cell Carcinoma (mRCC)

• 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

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-30
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-11
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-12
• Last Update Posted: 2016-01-13

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

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
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.
Treatment algorithm	at end of study	Follow up documentation

Trial Locations

Locations (1)

Novartis Investigative Site; 🇳🇴 Trondheim, Norway