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Nexavar Post-marketing Surveillance for Hepatocellular Carcinoma in Japan

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Carcinoma, Hepatocellular

Intervention: Sorafenib (Nexavar, BAY43-9006) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

Official title: Special Drug Use Investigation of Nexavar (Unresectable Hepatocellular Carcinoma)

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar

Secondary outcome:

Demography

Effectiveness evaluation assessment [overall survival, complete response rate, partial response rate, stable disease rate] by the Response Evaluation Criteria in Solid Tumor (RECIST)

Effectiveness evaluation assessment [time to progression, response rate, stable disease rate, progression rate] by investigator-determined overall best response

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]

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients who received Nexavar for unresectable hepatocellular carcinoma

Exclusion Criteria:

- Patients who are contraindicated based on the product label

Locations and Contacts

Many locations, Japan
Additional Information

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Starting date: May 2009
Last updated: March 3, 2015

Page last updated: August 23, 2015

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