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

Completed

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

• Registration Number: NCT01412671
• Lead Sponsor: Bayer

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

Not available

Study Timeline

• Study Start: 2008-02-27
• Study First Submitted: 2011-08-07
• Study First Submitted QC: 2011-08-07
• Study First Posted: 2011-08-09
• Primary Completion: 2011-09-21
• 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: 117

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, clinical staging of RCC, 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