Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Nexavar Post-marketing Surveillance for Hepatocellular Carcinoma in Japan

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Bayer Identifier:
First received: August 5, 2011
Last updated: December 1, 2014
Last verified: December 2014

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.

Condition Intervention
Carcinoma, Hepatocellular
Drug: Sorafenib (Nexavar, BAY43-9006)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Drug Use Investigation of Nexavar (Unresectable Hepatocellular Carcinoma)

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar [ Time Frame: After Nexavar administration, up to 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Demography [ Time Frame: Baseline ] [ Designated as 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) [ Time Frame: After Nexavar administration, up to 1 year ] [ Designated as safety issue: No ]
  • Effectiveness evaluation assessment [time to progression, response rate, stable disease rate, progression rate] by investigator-determined overall best response [ Time Frame: After Nexavar administration, up to 1 year ] [ Designated as 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] [ Time Frame: After Nexavar administration, up to 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: May 2009
Estimated Study Completion Date: January 2016
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Sorafenib (Nexavar, BAY43-9006)
Patients who have received Nexavar for unresectable HCC


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The target population of this study is patients who received Nexavar for unresectable HCC.


Inclusion Criteria:

  • Patients who received Nexavar for unresectable hepatocellular carcinoma

Exclusion Criteria:

  • Patients who are contraindicated based on the product label
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01411436

Many locations, Japan
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer Identifier: NCT01411436     History of Changes
Other Study ID Numbers: 15039, NEXAVAR-HCC-01
Study First Received: August 5, 2011
Last Updated: December 1, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:
unresectable hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial processed this record on February 27, 2015