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NCT00771147 Clinical Trial

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

Carcinoma, Renal Cell Clinical Trial

— PONDIAC  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00771147
Other study ID # 13102
Secondary ID NX0710BE
Status Completed
Phase N/A
First received October 9, 2008
Last updated June 14, 2012
Start date June 2008
Est. completion date November 2010

Study information
Verified date June 2012
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 71
Est. completion date November 2010
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Sorafenib (Nexavar, BAY43-9006)
Patients with diagnosis of advanced renal cell cancer and decision taken by the investigator to prescribe Nexavar®.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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