Overview

Nexavar Post-marketing Surveillance for RCC in Japan: Early Access Program

Status:
Completed

Trial end date:
2016-02-28

Target enrollment:
0

Participant gender:
All

Summary

This study is an early access program of 'Nexavar post-marketing surveillance (PMS) for renal cell carcinoma (RCC) in Japan' which is a regulatory, local prospective and observational study for patients with unresectable or advanced RCC under real-life practice conditions. The objective of this study is to assess safety and effectiveness of Nexavar at some limited sites which joined to clinical trial of Nexavar, before available of it in the market. The enrollment period is 2 months, and patients who received Nexavar will be recruited and followed one year since starting Nexavar administration. The data of this study will be integrated into the Nexavar PMS and the data will not be analyzed and reported alone.

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Bayer

Treatments:

Niacinamide
Sorafenib

Criteria

Inclusion Criteria:

- Patients who received Nexavar for unresectable or advanced renal cell carcinoma

Exclusion Criteria:

- Patients who are contraindicated based on the product label