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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01412671
First received: August 7, 2011
Last updated: April 10, 2012
Last verified: April 2012
History of Changes

August 7, 2011
April 10, 2012
February 2008
September 2011   (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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01412671 on ClinicalTrials.gov Archive Site
  • 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)] [ Time Frame: After Nexavar administration, up to 1 year ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • The status of therapy with Nexavar [duration of treatment, daily dose] [ Time Frame: After Nexavar administration, up to 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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)

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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

The target population of this study is patients who received Nexavar for unresectable or advanced RCC.
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
117
September 2011
September 2011   (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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01412671
15037, NEXAVAR-RCC-01
No
Head Medical Development Japan, Bayer Yakuhin, Ltd.
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP