Trial Condition(s):

Carcinoma, Renal Cell

Sorafenib in elderly mRCC

Bayer Identifier:

16399

ClinicalTrials.gov Identifier:

NCT01728948

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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%.

Inclusion Criteria
-  Patients with histologically/cytologically diagnosed metastasis RCC who are candidates for systemic therapy and have decided to accept Sorafenib treatment. 
 - >=65 years of age 
 - Patients who have signed the informed consent 
 - Patients with a life expectancy of ≥12 weeks 
 - No prior systemic treatment
Exclusion Criteria
- The approved local product label must be followed for the exclusion criteria

Trial Summary

Enrollment Goal
60
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, China

Status
Completed
 

Trial Design