Nexavar Post-marketing Surveillance for Hepatocellular Carcinoma in Japan
This study is currently recruiting participants.
Verified June 2013 by Bayer
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01411436
First received: August 5, 2011
Last updated: June 12, 2013
Last verified: June 2013
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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.
| 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 |
| Estimated 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
|
Eligibility| 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.
Criteria
Inclusion Criteria:
- Patients who received Nexavar for unresectable hepatocellular carcinoma
Exclusion Criteria:
- Patients who are contraindicated based on the product label
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411436
Contacts
| Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com |
Locations
| Japan | |
| Recruiting | |
| Many locations, Japan | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Head Medical Development Japan, Bayer Yakuhin Co.LTD. |
| ClinicalTrials.gov Identifier: | NCT01411436 History of Changes |
| Other Study ID Numbers: | 15039, NEXAVAR-HCC-01 |
| Study First Received: | August 5, 2011 |
| Last Updated: | June 12, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Bayer:
|
Nexavar unresectable hepatocellular carcinoma |
Additional relevant MeSH terms:
|
Carcinoma, Hepatocellular Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Liver Diseases Sorafenib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013