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Completed

NCT Number: NCT01411436

Nexavar Post-marketing Surveillance for Hepatocellular Carcinoma in Japan

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who received Nexavar for unresectable hepatocellular carcinoma

Exclusion criteria

  • Patients who are contraindicated based on the product label

Treatment and study plan

Sorafenib (Nexavar, BAY43-9006)

Drug

Patients who have received Nexavar for unresectable HCC

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Special Drug Use Investigation of Nexavar (Unresectable Hepatocellular Carcinoma)

Important dates

Study start
2009
Primary completion
2014
Study completion
2015
First posted
Aug 8, 2011
Registry last updated
Mar 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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