check_circleStudy Completed
Carcinoma, Hepatocellular
Bayer Identifier:
15039
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Nexavar post-marketing surveillance for hepatocellular carcinoma in Japan
Trial purpose
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.
Key Participants Requirements
Sex
BothAge
0 - N/ATrial summary
Enrollment Goal
1637Trial Dates
May 2009 - February 2015Phase
N/ACould I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations, Japan |
Primary Outcome
- Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavardate_rangeTime Frame:After Nexavar administration, up to 1 yearenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Demographydate_rangeTime Frame:Baselineenhanced_encryptionNoSafety Issue:
- Effectiveness evaluation assessment [overall survival, complete response rate, partial response rate, stable disease rate] by the Response Evaluation Criteria in Solid Tumor (RECIST)date_rangeTime Frame:After Nexavar administration, up to 1 yearenhanced_encryptionNoSafety Issue:
- Effectiveness evaluation assessment [time to progression, response rate, stable disease rate, progression rate] by investigator-determined overall best responsedate_rangeTime Frame:After Nexavar administration, up to 1 yearenhanced_encryptionNoSafety Issue:
- 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]date_rangeTime Frame:After Nexavar administration, up to 1 yearenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A