Nexavar Post-marketing Surveillance for Renal Cell Carcinoma in Japan

Completed

• Conditions: Carcinoma, Renal Cell
• Interventions: Drug: Sorafenib (Nexavar, BAY43-9006)

• Registration Number: NCT01411423
• Lead Sponsor: Bayer

Brief Summary

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have been administered with Nexavar for unresectable or advanced renal cell carcinoma (RCC). The objective of this study is to assess safety and effectiveness of Nexavar under real-life practice conditions. This study is an all case investigation of which the enrollment period is 15 months, and all patients who received Nexavar will be recruited and followed one year since starting Nexavar administration.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-18
• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-08-05
• Study First Posted: 2011-08-08
• Primary Completion: 2012-03-16
• Study Completion: 2016-02-28
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-04
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3305

Inclusion Criteria

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

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Exclusion Criteria

• Patients who are contraindicated based on the product label

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Sorafenib (Nexavar, BAY43-9006)	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar	After Nexavar administration, up to 1 year

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease, medical history data, clinical staging, etiology of HCC, Eastern Cooperative Oncology Group-Performance Status (ECOG-PS)]	After Nexavar administration, up to 1 year
Effectiveness evaluation assessment [overall survival, response rate, stable disease rate, progression disease rate] by investigator-determined overall best response [according to the General rule for clinical and pathological studies on RCC]	After Nexavar administration, up to 1 year
The status of therapy with Nexavar [duration of treatment, daily dose]	After Nexavar administration, up to 1 year