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

This study has been completed.
Information provided by:
Bayer Identifier:
First received: August 7, 2011
Last updated: April 10, 2012
Last verified: April 2012
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.

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: Early Access Program)

Resource links provided by NLM:

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, 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 ]

Enrollment: 117
Study Start Date: February 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The target population of this study is patients who received Nexavar for unresectable or advanced RCC.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01412671

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

Additional Information:
Responsible Party: Head Medical Development Japan, Bayer Yakuhin, Ltd. Identifier: NCT01412671     History of Changes
Other Study ID Numbers: 15037  NEXAVAR-RCC-01 
Study First Received: August 7, 2011
Last Updated: April 10, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:
unresectable or advanced renal cell carcinoma

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Diseases
Kidney Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors processed this record on May 22, 2016