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Nexavar Post-marketing Surveillance for Renal Cell Carcinoma in Japan

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ClinicalTrials.gov Identifier: NCT01411423
Recruitment Status : Completed
First Posted : August 8, 2011
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

August 5, 2011
August 8, 2011
June 5, 2018
April 18, 2008
March 16, 2012   (Final data collection date for primary outcome measure)
Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar [ Time Frame: After Nexavar administration, up to 1 year ]
Same as current
Complete list of historical versions of study NCT01411423 on ClinicalTrials.gov Archive Site
  • 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)] [ Time Frame: 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] [ Time Frame: After Nexavar administration, up to 1 year ]
  • The status of therapy with Nexavar [duration of treatment, daily dose] [ Time Frame: After Nexavar administration, up to 1 year ]
Same as current
Not Provided
Not Provided
 
Nexavar Post-marketing Surveillance for Renal Cell Carcinoma in Japan
Special Drug Use Investigation of Nexavar (Unresectable or Advanced Renal Cell Carcinoma)
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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
This study is all cases investigation of which the enrollment period is 15 months, and all patients who received Nexavar for unresectable or advanced RCC will be recruited.
Carcinoma, Renal Cell
Drug: Sorafenib (Nexavar, BAY43-9006)
Patients who have received Nexavar for unresectable or advanced RCC.
Group 1
Intervention: Drug: Sorafenib (Nexavar, BAY43-9006)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3305
3300
February 28, 2016
March 16, 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who are contraindicated based on the product label
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01411423
15038
NEXAVAR-RCC-02 ( Other Identifier: Company Internal )
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
June 2018