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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:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00771147
First received: October 9, 2008
Last updated: June 14, 2012
Last verified: June 2012

October 9, 2008
June 14, 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 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00771147 on ClinicalTrials.gov Archive Site
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00771147
13102, NX0710BE
No
Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP