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NCT Number: NCT01390519

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

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.

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Key information

Conditions

Metastatic Renal Cell Carcinoma (mRCC) Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Kristiansand, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

everolimis

Other

Other names: RAD001

Primary outcomes

  1. Time to progression (TTP)

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

Secondary outcomes

  1. Treatment algorithm

    Time frame: at end of study

    Follow up documentation

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

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

    Follow up documentation

  3. 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: OSAT

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jul 11, 2011
Registry last updated
Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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