check_circleStudy Completed

Carcinoma, Hepatocellular

Bayer Identifier:

15039

ClinicalTrials.gov Identifier:

NCT01411436

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

Both

Age

0 - N/A
  • - Patients who received Nexavar for unresectable hepatocellular carcinoma

  • - Patients who are contraindicated based on the product label

Trial summary

Enrollment Goal
1637
Trial Dates
May 2009 - February 2015
Phase
N/A
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, Japan

Primary Outcome

  • Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar
    date_rangeTime Frame:
    After Nexavar administration, up to 1 year
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Demography
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No
  • 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 year
    enhanced_encryption
    Safety Issue:
    No
  • Effectiveness evaluation assessment [time to progression, response rate, stable disease rate, progression rate] by investigator-determined overall best response
    date_rangeTime Frame:
    After Nexavar administration, up to 1 year
    enhanced_encryption
    Safety Issue:
    No
  • 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 year
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

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