Status:
COMPLETED
Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer
Lead Sponsor:
Pfizer
Conditions:
Kidney Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer.
Eligibility Criteria
Inclusion
- Histologically documented metastatic renal cell cancer with a component of clear cell histology.
- Evidence of measurable disease.
- Patients with mRCC must have received no prior systemic first-line therapy or must have progressive disease per RECIST (version 1.0) after one prior systemic first line regimen for metastatic disease containing sunitinib, cytokine(s), or both.
Exclusion
- Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy.
- Major surgery less that 4 weeks or radiation less than 2 weeks of starting study drug.
Key Trial Info
Start Date :
August 25 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2021
Estimated Enrollment :
492 Patients enrolled
Trial Details
Trial ID
NCT00920816
Start Date
August 25 2009
End Date
April 29 2021
Last Update
May 6 2022
Active Locations (125)
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1
Advanced Medical Specialties
Miami, Florida, United States, 33143
2
Advanced Medical Specialties
Miami, Florida, United States, 33176
3
Illinois Cancer Specialists
Arlington Heights, Illinois, United States, 60005
4
Illinois Cancer Specialists
Niles, Illinois, United States, 60714