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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00771147
First Posted: October 13, 2008
Last Update Posted: June 15, 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
October 9, 2008
October 13, 2008
June 15, 2012
June 2008
Not Provided
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 ]
Not Provided
Complete list of historical versions of study NCT00771147 on ClinicalTrials.gov Archive Site
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Not Provided
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A Trial to Evaluate the Characteristics of Patients Treated for Advanced Renal Cell Carcinoma With Nexavar ®
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
Evaluation of the efficacy and safety of Nexavar ® in advanced Renal Cell Carcinoma (RCC) and calculation of related medical costs.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:
n.a
Non-Probability Sample
Patients with diagnosis of advanced Renal Cell Carcimona
  • Carcinoma, Renal Cell
  • Carcinoma, Renal Cell (Advanced)
Drug: Sorafenib (Nexavar, BAY43-9006)
Patients with diagnosis of advanced renal cell cancer and decision taken by the investigator to prescribe Nexavar®.
Group 1
Intervention: Drug: Sorafenib (Nexavar, BAY43-9006)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
November 2010
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT00771147
13102
NX0710BE
No
Not Provided
Not Provided
Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
June 2012