Status:
COMPLETED
A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer
Lead Sponsor:
Pfizer
Conditions:
Kidney Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To compare the disease free survival time and safety of sunitinib with placebo in adjuvant treatment patients at high risk of recurrent kidney cancer after surgery.
Eligibility Criteria
Inclusion
- High risk renal cancer per modified UISS criteria
- Eastern Cooperative Oncology Group (ECOG) 0-2
- predominant clear cell histology
- No prior anti-cancer treatment
- Kidney tumor has been removed
- No evidence of macroscopic disease following surgery
Exclusion
- Histologically undifferentiated carcinomas or collecting duct carcinoma, lymphoma, sarcoma or subjects with metastatic renal sites.
- Diagnosis of any second malignancy within the last 5 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for 12 months
- known HIV or Hepatitis
- any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2017
Estimated Enrollment :
674 Patients enrolled
Trial Details
Trial ID
NCT00375674
Start Date
August 1 2007
End Date
September 7 2017
Last Update
September 21 2018
Active Locations (115)
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1
Ronald Reagan UCLA Medical Center Department of Pharmaceutical Services
Los Angeles, California, United States, 90095
2
UCLA Clark Urology Center
Los Angeles, California, United States, 90095
3
Emory University Hospital
Atlanta, Georgia, United States, 30322
4
The Emory Clinic, Inc
Atlanta, Georgia, United States, 30322