Sunitinib in Metastatic Renal Cancer

Carcinoma, Renal Cell Clinical Trial

Official title: Phase II Study of Sunitinib in Metastatic Renal Cancer With Non-clear Cell Histology

Status Completed

Clinical Trial Summary

Sunitinib is the registered treatment for first-line therapy of metastatic clear-cell carcinoma of the kidney.Data from the Expanded Access Study have shown activity also in non-clear cell renal cancer (NCCRC). The aim of this study is to prospectively evaluate the anti-tumor activity and safety of sunitinib as a first-line therapy in metastatic NCCRC patients.

Clinical Trial Description

This is a prospective, open label, multicenter phase II study to evaluate efficacy of Sunitinib (in advanced/metastatic renal cancer with non-clear cell histology (papillary or chromophobe).

Sunitinib will be administered orally at a dose of 50 mg once daily, in six weeks cycles consisting of 4 weeks on treatment followed by 2 weeks off.

Treatment with the study drug will continue until tumor progression or unacceptable toxicity.

The planned total sample size for this study is 55 patients. Approximately 10 study sites will be involved. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell

• NCT number: NCT01034878
• Study type: Interventional
• Source: Istituto Clinico Humanitas
• Status: Completed
• Phase: Phase 2
• Start date: December 2009
• Completion date: December 2014