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

Carcinoma, Renal Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01412671
• Other study ID #: 15037
• Secondary ID: NEXAVAR-RCC-01
• Status: Completed
• Start date: February 27, 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: February 28, 2016
• Est. primary completion date: September 21, 2011
• 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, clinical staging of RCC, 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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