Nexavar Post-marketing Surveillance for Renal Cell Carcinoma in Japan

Special Drug Use Investigation of Nexavar (Unresectable or Advanced Renal Cell Carcinoma)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01411423

Enrollment

3305

Registered

2011-08-08

Start date

2008-04-18

Completion date

2016-02-28

Last updated

2018-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Renal Cell

Keywords

Nexavar, Unresectable or advanced renal cell carcinoma

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 been administered with Nexavar for unresectable or advanced renal cell carcinoma (RCC). 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 15 months, and all patients who received Nexavar will be recruited and followed one year since starting Nexavar administration.

Interventions

DRUGSorafenib (Nexavar, BAY43-9006)

Patients who have received Nexavar for unresectable or advanced RCC.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients who received Nexavar for unresectable or advanced renal cell carcinoma

Exclusion criteria

* Patients who are contraindicated based on the product label

Design outcomes

Primary

Measure	Time frame
Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar	After Nexavar administration, up to 1 year

Secondary

Measure	Time frame
Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease, medical history data, clinical staging, etiology of HCC, Eastern Cooperative Oncology Group-Performance Status (ECOG-PS)]	After Nexavar administration, up to 1 year
Effectiveness evaluation assessment [overall survival, response rate, stable disease rate, progression disease rate] by investigator-determined overall best response [according to the General rule for clinical and pathological studies on RCC]	After Nexavar administration, up to 1 year
The status of therapy with Nexavar [duration of treatment, daily dose]	After Nexavar administration, up to 1 year

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026