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Nexavar Post-marketing Surveillance for Renal Cell Carcinoma in Japan

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01411423
First received: August 5, 2011
Last updated: April 10, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Carcinoma, Renal Cell
 Drug: Sorafenib (Nexavar, BAY43-9006)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Drug Use Investigation of Nexavar (Unresectable or Advanced Renal Cell Carcinoma)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ] [ 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 ]

Enrollment: 3304
Study Start Date: April 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Sorafenib (Nexavar, BAY43-9006)
Patients who have received Nexavar for unresectable or advanced RCC.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who are contraindicated based on the product label
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411423

Locations
Japan
Many Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Head Medical Development Japan, Bayer Yakuhin, Ltd.
ClinicalTrials.gov Identifier: NCT01411423     History of Changes
Other Study ID Numbers: 15038, NEXAVAR-RCC-02
Study First Received: August 5, 2011
Last Updated: April 10, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:
Nexavar
Unresectable or advanced renal cell carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Kidney Diseases
Urologic Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013