Nexavar Post-marketing Surveillance for Renal Cell Carcinoma in Japan

Carcinoma, Renal Cell Clinical Trial

Official title:

Special Drug Use Investigation of Nexavar (Unresectable or Advanced Renal Cell Carcinoma)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01411423
• Other study ID #: 15038
• Secondary ID: NEXAVAR-RCC-02
• Status: Completed
• Start date: April 18, 2008
• Est. completion date: February 28, 2016

Study information

• Verified date: June 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3305
• Est. completion date: February 28, 2016
• Est. primary completion date: March 16, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients who are contraindicated based on the product label

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

Intervention

Drug:
• Sorafenib (Nexavar, BAY43-9006)
Patients who have received Nexavar for unresectable or advanced RCC.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar		After Nexavar administration, up to 1 year
Secondary	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
Secondary	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
Secondary	The status of therapy with Nexavar [duration of treatment, daily dose]		After Nexavar administration, up to 1 year

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