Trial Condition(s):

Carcinoma, Renal Cell

Nexavar post-marketing surveillance for RCC in Japan: Early access program

Bayer Identifier:

15037

ClinicalTrials.gov Identifier:

NCT01412671

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

Inclusion Criteria
- Patients who received Nexavar for unresectable or advanced renal cell carcinoma
Exclusion Criteria
- Patients who are contraindicated based on the product label

Trial Summary

Enrollment Goal
117
Trial Dates
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Phase
N/A
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, Japan

Status
Completed
 

Trial Design