Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients — ATLAS  

Clear Cell Renal Carcinoma Clinical Trial

Official title: Adjuvant Axitinib Treatment of Renal Cancer: A Randomized Double-blind Phase 3 Study of Adjuvant Axitinib vs. Placebo in Subjects at High Risk of Recurrent RCC

Status Terminated

Clinical Trial Summary

The purpose of this trial is to determine if adjuvant therapy with axitinib will prevent or delay the recurrence of renal cell cancer after surgery to remove the primary tumor in high risk patients.

Clinical Trial Description

This is a prospective, randomized, double blind placebo controlled Phase 3 trial of oral axitinib starting at 5 mg twice daily given 3 years vs. placebo.

Approximately 700 patients will be randomized in a 1:1 ratio between axitinib vs placebo. ;

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Clear Cell Renal Carcinoma
• Kidney Neoplasms

• NCT number: NCT01599754
• Study type: Interventional
• Source: SFJ Pharmaceuticals, Inc.
• Status: Terminated
• Phase: Phase 3
• Start date: April 2012
• Completion date: May 2018