Nexavar Post-marketing Surveillance for Hepatocellular Carcinoma in Japan

NCT01411436 | Completed

• 2 other identifiers: 15039NEXAVAR-HCC-01
• Study Type: observational
• Target: 1,637
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Hepatocellular

Keywords

Nexavar; unresectable hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar

  After Nexavar administration, up to 1 year

Secondary Outcomes (4)

• Demography

  Baseline

• Effectiveness evaluation assessment [overall survival, complete response rate, partial response rate, stable disease rate] by the Response Evaluation Criteria in Solid Tumor (RECIST)

  After Nexavar administration, up to 1 year

• Effectiveness evaluation assessment [time to progression, response rate, stable disease rate, progression rate] by investigator-determined overall best response

  After Nexavar administration, up to 1 year

• 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]

  After Nexavar administration, up to 1 year

Study Arms (1)

Group 1

Drug: Sorafenib (Nexavar, BAY43-9006)

Interventions

Sorafenib (Nexavar, BAY43-9006) DRUG

Patients who have received Nexavar for unresectable HCC

Group 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients who received Nexavar for unresectable hepatocellular carcinoma

You may not qualify if:

• Patients who are contraindicated based on the product label

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, Japan

Location

Related Publications (1)

• Kaneko S, Ikeda K, Matsuzaki Y, Furuse J, Minami H, Okayama Y, Sunaya T, Ito Y, Inuyama L, Okita K. Safety and effectiveness of sorafenib in Japanese patients with hepatocellular carcinoma in daily medical practice: interim analysis of a prospective postmarketing all-patient surveillance study. J Gastroenterol. 2016 Oct;51(10):1011-21. doi: 10.1007/s00535-016-1173-5. Epub 2016 Mar 1.

  PMID: 26931117 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: August 8, 2011
• Study Start: May 1, 2009
• Primary Completion: March 1, 2014
• Study Completion: February 1, 2015
• Last Updated: March 4, 2015

Record last verified: 2015-03

Locations

JP (1)