Trial Condition(s):
Carcinoma, Hepatocellular
Nexavar post-marketing surveillance for hepatocellular carcinoma in Japan
Bayer Identifier:
15039
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
- Patients who received Nexavar for unresectable hepatocellular carcinoma
Exclusion Criteria
- Patients who are contraindicated based on the product label
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many locations, Japan | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Special drug use investigation of Nexavar (unresectable hepatocellular carcinoma)
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Incidence of adverse drug reactions and serious adverse events in subjects who received NexavarTimeframe: After Nexavar administration, up to 1 year
Secondary Outcome
- DemographyTimeframe: Baseline
- Effectiveness evaluation assessment [overall survival, complete response rate, partial response rate, stable disease rate] by the Response Evaluation Criteria in Solid Tumor (RECIST)Timeframe: After Nexavar administration, up to 1 year
- Effectiveness evaluation assessment [time to progression, response rate, stable disease rate, progression rate] by investigator-determined overall best responseTimeframe: After Nexavar administration, up to 1 year
- 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]Timeframe: After Nexavar administration, up to 1 year
Additional Information
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