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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01411423
Other study ID # 15038
Secondary ID NEXAVAR-RCC-02
Status Completed
Phase
First received
Last updated
Start date April 18, 2008
Est. completion date February 28, 2016

Study information

Verified date June 2018
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 3305
Est. completion date February 28, 2016
Est. primary completion date March 16, 2012
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Patients who are contraindicated based on the product label

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sorafenib (Nexavar, BAY43-9006)
Patients who have received Nexavar for unresectable or advanced RCC.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar After Nexavar administration, up to 1 year
Secondary 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
Secondary 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
Secondary The status of therapy with Nexavar [duration of treatment, daily dose] After Nexavar administration, up to 1 year
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