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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01412671
First Posted: August 9, 2011
Last Update Posted: April 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bayer
  Purpose
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 ]

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 ]
  • 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 ]

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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412671


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

Additional Information:
Responsible Party: Head Medical Development Japan, Bayer Yakuhin, Ltd.
ClinicalTrials.gov Identifier: NCT01412671     History of Changes
Other Study ID Numbers: 15037
NEXAVAR-RCC-01 ( Other Identifier: Company Internal )
First Submitted: August 7, 2011
First Posted: August 9, 2011
Last Update Posted: April 12, 2012
Last Verified: April 2012

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
Niacinamide
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs