Status:
TERMINATED
Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy
Lead Sponsor:
Pfizer
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
This study will compare the safety and efficacy of sunitinib in combination with prednisone versus placebo and prednisone in patients that have metastatic castration-resistant prostate cancer that has...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed adenocarcinoma of the prostate.
- Progressive, metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy (resistant or intolerant).
- Progressive disease based on PSA progression, RECIST, or positive bone scan.
- ECOG 0 or 1.
Exclusion
- Prior treatment with sunitinib and/or more than 1 prior chemotherapy regimen in the metastatic disease setting.
- Chemotherapy within 3 weeks.
- Impending complications from bone metastases.
- Ongoing urinary obstruction.
- Cardiac dysfunction, QTc \>470 msec.
- CNS involvement.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
873 Patients enrolled
Trial Details
Trial ID
NCT00676650
Start Date
July 1 2008
End Date
December 1 2011
Last Update
March 8 2013
Active Locations (205)
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1
Pfizer Investigational Site
Decatur, Alabama, United States, 35601
2
Pfizer Investigational Site
Huntsville, Alabama, United States, 35801
3
Pfizer Investigational Site
Huntsville, Alabama, United States, 35805
4
Pfizer Investigational Site
Anaheim, California, United States, 92801