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Nexavar Post-marketing Surveillance for Hepatocellular Carcinoma in Japan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01411436
Recruitment Status : Completed
First Posted : August 8, 2011
Last Update Posted : March 4, 2015
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Carcinoma, Hepatocellular Drug: Sorafenib (Nexavar, BAY43-9006)

Study Design

Study Type : Observational
Actual Enrollment : 1637 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Drug Use Investigation of Nexavar (Unresectable Hepatocellular Carcinoma)
Study Start Date : May 2009
Primary Completion Date : March 2014
Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Group 1 Drug: Sorafenib (Nexavar, BAY43-9006)
Patients who have received Nexavar for unresectable HCC

Outcome Measures

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

Secondary Outcome Measures :
  1. Demography [ Time Frame: Baseline ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411436

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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01411436     History of Changes
Other Study ID Numbers: 15039
NEXAVAR-HCC-01 ( Other Identifier: Company Internal )
First Posted: August 8, 2011    Key Record Dates
Last Update Posted: March 4, 2015
Last Verified: March 2015

Keywords provided by Bayer:
unresectable hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs