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

Metastatic Renal Cell Carcinoma (mRCC) Clinical Trial

— OSAT  

Official title:

Observational Study Evaluating Efficacy, Tolerability and Treatment Algorithm of Advanced Renal Cell Cancer Patients Under Afinitor Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01390519
• Other study ID #: CRAD001LNO03
• Status: Completed
• Phase: N/A
• First received: June 30, 2011
• Last updated: January 12, 2016
• Start date: June 2011
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Etisk Komite Nord
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma (mRCC)

Intervention

Other:
• everolimis

Locations

Country	Name	City	State
Norway	Novartis Investigative Site	Kristiansand
Norway	Novartis Investigative Site	Tromsø
Norway	Novartis Investigative Site	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression (TTP)		maximum of 12 months after inclusion of the last patient	No
Secondary	Treatment algorithm	Follow up documentation	at end of study	No
Secondary	Quality of life (QoL)(EORTC-QLQ C30)	Follow up documentation	maximum of 12 months after inclusion of the last patient	No
Secondary	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	Yes