Nexavar Post-marketing Surveillance for RCC in Japan: Early Access Program

Special Drug Use Investigation of Nexavar (Unresectable or Advanced Renal Cell Carcinoma: Early Access Program)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01412671

Enrollment

117

Registered

2011-08-09

Start date

2008-02-27

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 an early access program of 'Nexavar post-marketing surveillance (PMS) for renal cell carcinoma (RCC) in Japan' which is a regulatory, local prospective and observational study for patients with unresectable or advanced RCC under real-life practice conditions. The objective of this study is to assess safety and effectiveness of Nexavar at some limited sites which joined to clinical trial of Nexavar, before available of it in the market. The enrollment period is 2 months, and patients who received Nexavar will be recruited and followed one year since starting Nexavar administration. The data of this study will be integrated into the Nexavar PMS and the data will not be analyzed and reported alone.

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
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
Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease, clinical staging of RCC, Eastern Cooperative Oncology Group-Performance Status (ECOG-PS)]	After Nexavar administration, up to 1 year

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026