Nexavar Post-marketing Surveillance for Hepatocellular Carcinoma in Japan

Carcinoma, Hepatocellular Clinical Trial

Official title:

Special Drug Use Investigation of Nexavar (Unresectable Hepatocellular Carcinoma)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01411436
• Other study ID #: 15039
• Secondary ID: NEXAVAR-HCC-01
• Status: Completed
• Phase: N/A
• First received: August 5, 2011
• Last updated: March 3, 2015
• Start date: May 2009
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• 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 received Nexavar for unresectable hepatocellular carcinoma (HCC). 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 2 or 3 months (dependent on sites) for Child-Pugh A; for Child-Pugh B or C, the enrollment continues until agreement to stop with Pharmaceuticals Medical Devices Agency (PMDA). All patients who have received Nexavar will be recruited and followed one year since starting Nexavar administration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1637
• Est. completion date: February 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who received Nexavar for unresectable hepatocellular carcinoma

Exclusion Criteria:

• Patients who are contraindicated based on the product label

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• Sorafenib (Nexavar, BAY43-9006)
Patients who have received Nexavar for unresectable HCC

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	Yes
Secondary	Demography		Baseline	No
Secondary	Effectiveness evaluation assessment [overall survival, complete response rate, partial response rate, stable disease rate] by the Response Evaluation Criteria in Solid Tumor (RECIST)		After Nexavar administration, up to 1 year	No
Secondary	Effectiveness evaluation assessment [time to progression, response rate, stable disease rate, progression rate] by investigator-determined overall best response		After Nexavar administration, up to 1 year	No
Secondary	The status of therapy with Nexavar [duration of treatment, daily dose] in a various settings according to baseline data [such as demographic data, Child-Pugh status, ECOG-PS]		After Nexavar administration, up to 1 year	No

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