NCT01599754

Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 724 (actual)
• Sponsor: SFJ Pharma Ltd. II · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Clear Cell Renal Carcinoma

Interventions

Type	Name	Description
DRUG	Axitinib	Axitinib 5 mg twice daily
DRUG	Placebo	Placebo twice daily

Timeline

• Start date: 2012-04-01
• Primary completion: 2017-10-10
• Completion: 2018-05-01
• First posted: 2012-05-16
• Last updated: 2019-09-20
• Results posted: 2019-08-28

Locations

106 sites across 9 countries: United States, China, France, Hong Kong, India, Japan, South Korea, Spain, Taiwan