Status:
COMPLETED
Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Astellas Pharma Inc
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Conditions:
Castration-Resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemothera...
Eligibility Criteria
Inclusion
- Progressive prostate cancer
- Medical or surgical castration with testosterone less than 50 ng/dl
- One or two prior chemotherapy regimens. At least one chemotherapy regimen must have contained docetaxel
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate bone marrow, hepatic, and renal function
- Able to swallow the study drug and comply with study requirements
- Informed consent
Exclusion
- Metastases in the brain or active epidural disease
- Another malignancy within the previous 5 years
- Clinically significant cardiovascular disease
- Gastrointestinal disorder affecting absorption
Key Trial Info
Start Date :
September 30 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2017
Estimated Enrollment :
1199 Patients enrolled
Trial Details
Trial ID
NCT00974311
Start Date
September 30 2009
End Date
November 2 2017
Last Update
December 11 2018
Active Locations (249)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
3
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
4
Premiere Oncology of Arizona
Scottsdale, Arizona, United States, 85258