check_circleStudy Completed

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

Bayer Identifier:

14686

ClinicalTrials.gov Identifier:

NCT00895674

EudraCT Number:

Not Available

EU CT Number:

Not Available
Patient characteristics in advanced renal cell carcinoma and daily practice treatment with Nexavar

Trial purpose

Renal cell carcinoma accounts for roughly 3 % of all cancer. It is a rather aggressive cancer type, which means that patients who present with an advanced disease have a rather poor prognosis. When this study has been started the standard therapy for patients has been cytokines, which might be accompanied by significant toxicities or might fail the therapeutic goal. In these cases sorafenib can be a feasible therapeutic option. This non-interventional study has been created and is being conducted to collect clinical data on the patients' therapy with sorafenib in an everyday treatment schedule. The main goal of this study focuses on patient characteristics and tumor status in RCC treated with sorafenib as well as the treatment duration and safety of sorafenib under everyday treatment conditions.

Key Participants Requirements

Sex

Both

Age

18 - N/A

  • - Patients with diagnosis of advanced RCC and decision taken by the investigator to prescribe Sorafenib

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

Trial summary

Enrollment Goal
2840
Trial Dates
July 2006 - August 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, France
Completed
Many Locations, Netherlands
Completed
Many Locations, Argentina
Completed
Many Locations, Greece
Completed
Many Locations, Slovakia
Completed
Many Locations, Korea, Republic Of
Completed
Many Locations, Philippines
Completed
Many Locations, Germany
Completed
Many Locations, Poland
Completed
Many Locations, Mexico
Completed
Many Locations, Sweden
Completed
Many Locations, Czech Republic
Completed
Many Locations, Austria
Completed
Many Locations, Colombia
Completed
Many Locations, Russia
Completed
Many Locations, China
Completed
Many Locations, Indonesia
Completed
Many Locations, Slovenia

Primary Outcome

  • Tumor status
    date_rangeTime Frame:
    After about 3, 6, 9 and 12 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Treatment duration
    date_rangeTime Frame:
    At end of study after about 12 months
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    Safety Issue:
    No
  • Safety of sorafenib treatment
    date_rangeTime Frame:
    At every documented visit for about 12 months
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    Safety Issue:
    Yes
  • Progression-free survival
    date_rangeTime Frame:
    Calculation at end of study after about 12 months
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    Safety Issue:
    No
  • Status of Metastases
    date_rangeTime Frame:
    After about 3, 6, 9 and 12 months
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    Safety Issue:
    No
  • Performance status (ECOG)
    date_rangeTime Frame:
    After about 3, 6, 9 and 12 months
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    Safety Issue:
    No

Trial design

Patient characteristics in advanced renal cell carcinoma and daily practice treatment with Nexavar
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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