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

Completed

• Conditions: Carcinoma, Renal Cell; Carcinoma, Renal Cell (Advanced)
• Interventions: Drug: Sorafenib (Nexavar, BAY43-9006)

• Registration Number: NCT00771147
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-10-09
• Study First Submitted QC: 2008-10-10
• Study First Posted: 2008-10-13
• Study Completion: 2010-11
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-14
• Last Update Posted: 2012-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Sorafenib (Nexavar, BAY43-9006)	-

Primary Outcome Measures

Name	Time	Method
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	At 1, 3, 6 and 9 months and after one year