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

Novartis Pharmaceuticals30 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Metastatic Renal Cell Carcinoma (mRCC)

Interventions

everolimisOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Novartis Investigative Site

Kristiansand, Norway

Novartis Investigative Site

Tromsø, Norway

Novartis Investigative Site

Trondheim, Norway

Outcomes

Primary Outcomes

Time to progression (TTP)

Time frame: maximum of 12 months after inclusion of the last patient

Secondary Outcomes

Treatment algorithm

Follow up documentation

Time frame: at end of study

Quality of life (QoL)(EORTC-QLQ C30)

Follow up documentation

Time frame: maximum of 12 months after inclusion of the last patient

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.

Time frame: maximum of 12 months after inclusion of the last patient

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.