Status:
COMPLETED
SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
Lead Sponsor:
Pfizer
Conditions:
Carcinoma, Renal Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to test whether SU011248 has activity and is safe compared to interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).
Eligibility Criteria
Inclusion
- Histologically confirmed renal cell carcinoma of clear cell histology with metastases
- Evidence of measurable disease by radiographic technique
- Eastern Cooperative Oncology Group \[ECOG\] performance status of 0 or 1
Exclusion
- Prior systemic (including adjuvant or neoadjuvant) therapy of any kind for RCC
- History of or known brain metastases
- Serious acute or chronic illness or recent history of significant cardiac abnormality
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT00083889
Start Date
August 1 2004
End Date
September 1 2008
Last Update
January 26 2010
Active Locations (123)
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1
Pfizer Investigational Site
Jonesboro, Arkansas, United States, 72401
2
Pfizer Investigational Site
La Jolla, California, United States, 92037
3
Pfizer Investigational Site
La Jolla, California, United States, 92093
4
Pfizer Investigational Site
Los Angeles, California, United States, 90095