Overview

Sorafenib in Elderly mRCC

Status:
Completed
Trial end date:
2017-01-16
Target enrollment:
Participant gender:
Summary
This prospective, single arm, multi-center pilot study includes 120 mRCC patients over 65 years, no prior systemic treatment, determined to be candidates for systemic therapy by the investigator. The treatment with Sorafenib should comply with the recommendations written in the local product information. The primary endpoint is overall survival. The secondary endpoints including other effectiveness points, safety and patients characteristics. With 120 completed patients, if the observed survival rate at 12 months is 60%, the width of a 95% confidence interval will be approximately 18%.
Details
Lead Sponsor:
Bayer
Treatments:
Niacinamide
Sorafenib