Nexavar Post-marketing Surveillance for Renal Cell Carcinoma in Japan

June 4, 2018 updated by: Bayer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3305

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Multiple Locations, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who are contraindicated based on the product label

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Sorafenib (Nexavar, BAY43-9006)
Patients who have received Nexavar for unresectable or advanced RCC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar
Time Frame: After Nexavar administration, up to 1 year
After Nexavar administration, up to 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
After Nexavar administration, up to 1 year
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
After Nexavar administration, up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2008

Primary Completion (Actual)

March 16, 2012

Study Completion (Actual)

February 28, 2016

Study Registration Dates

First Submitted

August 5, 2011

First Submitted That Met QC Criteria

August 5, 2011

First Posted (Estimate)

August 8, 2011

Study Record Updates

Last Update Posted (Actual)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 4, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15038
  • NEXAVAR-RCC-02 (Other Identifier: Company Internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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3
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