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Nexavar Post-marketing Surveillance for Hepatocellular Carcinoma in Japan

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01411436
First received: August 5, 2011
Last updated: September 3, 2014
Last verified: September 2014

August 5, 2011
September 3, 2014
May 2009
March 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01411436 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Nexavar Post-marketing Surveillance for Hepatocellular Carcinoma in Japan
Special Drug Use Investigation of Nexavar (Unresectable Hepatocellular Carcinoma)

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Carcinoma, Hepatocellular
Drug: Sorafenib (Nexavar, BAY43-9006)
Patients who have received Nexavar for unresectable HCC
Group 1
Intervention: Drug: Sorafenib (Nexavar, BAY43-9006)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1200
January 2016
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who received Nexavar for unresectable hepatocellular carcinoma

Exclusion Criteria:

  • Patients who are contraindicated based on the product label
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01411436
15039, NEXAVAR-HCC-01
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP