A Trial to Evaluate the Characteristics of Patients Treated for Advanced Renal Cell Carcinoma With Nexavar ® - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

October 9, 2008

Last Updated Date

May 12, 2009

Start Date ^†

June 2008

Current Primary Outcome Measures ^†

Proportion of patients who are progression-free at one year according to the RECIST criteria. The proportion of patients who are progression-free at 1, 3, 6 and 9 months will also be calculated [ Time Frame: At 1, 3, 6 and 9 months and after one year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00771147 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

A Trial to Evaluate the Characteristics of Patients Treated for Advanced Renal Cell Carcinoma With Nexavar ®

Official Title ^†

Prospective Open-Label Non-Interventional, Non-Controlled Multi Observational and Pharmaco-Economic Phase IV Trial to Evaluate the Characteristics of Patients Treated for Advanced Renal Cell Carcinoma With Nexavar ® as Well as Effectiveness, Safety and Direct Medical Costs of Nexavar® Treatment Under Daily-Life Treatment Conditions

Brief Summary

Evaluation of the efficacy and safety of Nexavar ® in advanced Renal Cell Carcinoma (RCC) and calculation of related medical costs.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Observational

Study Design ^†

Cohort, Prospective

Condition ^†

Advanced Renal Cell Carcinoma ( RCC)

Intervention ^†

Drug: Nexavar (Sorafenib, BAY43-9006)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

125

Estimated Completion Date

October 2010

Estimated Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Patients with diagnosis of advanced RCC and decision taken by the investigator to prescribe Nexavar®. The patients should have sufficient knowledge of French or Dutch to be able to participate in the Study

Exclusion Criteria:

Exclusion criteria must be read in conjunction with the Belgian product information

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Location Countries ^†

Belgium

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00771147

Responsible Party

Medical Affairs Therapeutic Area Head, Bayer Schering Pharma AG

Secondary IDs ^††

Study Sponsor ^†

Bayer

Collaborators ^††

Investigators ^†

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

May 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.