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

January 12, 2016 updated by: Novartis Pharmaceuticals

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Kristiansand, Norway, 4615
        • Novartis Investigative Site
      • Tromsø, Norway, 9038
        • Novartis Investigative Site
      • Trondheim, Norway, 7006
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced renal cell cancer whose disease has progressed on or after one VEGF-TKI therapy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Afinitor
Other: everolimis
Other Names:
  • RAD001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to progression (TTP)
Time Frame: maximum of 12 months after inclusion of the last patient
maximum of 12 months after inclusion of the last patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment algorithm
Time Frame: at end of study
Follow up documentation
at end of study
Quality of life (QoL)(EORTC-QLQ C30)
Time Frame: maximum of 12 months after inclusion of the last patient
Follow up documentation
maximum of 12 months after inclusion of the last patient
Tolerability
Time Frame: 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.
maximum of 12 months after inclusion of the last patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 30, 2011

First Submitted That Met QC Criteria

July 7, 2011

First Posted (Estimate)

July 11, 2011

Study Record Updates

Last Update Posted (Estimate)

January 13, 2016

Last Update Submitted That Met QC Criteria

January 12, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRAD001LNO03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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