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: DemographyEffectiveness 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
Click here and search for drug information provided by the FDA. Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
Starting date: May 2009
Last updated: March 3, 2015
|