check_circleStudy Completed

Carcinoma, Renal Cell, Carcinoma, Renal Cell (Advanced)

Bayer Identifier:

13102

ClinicalTrials.gov Identifier:

NCT00771147

EudraCT Number:

Not Available

EU CT Number:

Not Available
A Trial to Evaluate the Characteristics of Patients Treated for Advanced Renal Cell Carcinoma With Nexavar ®

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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 must be read in conjunction with the Belgian product information

Trial summary

Enrollment Goal
71
Trial Dates
June 2008 - November 2010
Phase
N/A
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Belgium

Primary Outcome

  • 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
    date_rangeTime Frame:
    At 1, 3, 6 and 9 months and after one year
    enhanced_encryption
    Safety Issue:
    no

Trial design

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
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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