Spots Global Cancer Trial Database for Nexavar Post-marketing Surveillance for RCC in Japan: Early Access Program

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

Official Title: Special Drug Use Investigation of Nexavar (Unresectable or Advanced Renal Cell Carcinoma: Early Access Program)

Study ID: NCT01412671

Conditions

Carcinoma, Renal Cell

Interventions

Sorafenib (Nexavar, BAY43-9006)

Study Description

Brief 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.

Detailed Description: