Status:
COMPLETED
A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Astellas Pharma Inc
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate canc...
Eligibility Criteria
Inclusion
- Randomized, Double Blind Treatment Period:
- Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
- Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy
- Progressive disease despite androgen deprivation therapy as defined by rising PSA levels or progressive soft tissue or bony disease
- No prior treatment with cytotoxic chemotherapy
- Asymptomatic or mildly symptomatic from prostate cancer
Exclusion
- Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment
- Known or suspected brain metastasis or active leptomeningeal disease
- History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer
- Open-Label Treatment Period:
- The following inclusion criteria apply to patients receiving enzalutamide or placebo during double-blind treatment.
- Eligible patients must meet all inclusion criteria.
- Received randomized double-blind treatment in PREVAIL;
- Open-label day 1 visit is within 6 months after this amendment is approved and becomes effective at the study site;
- Is willing to maintain androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or has had a bilateral orchiectomy;
- The exclusion criteria apply only to patients starting new treatment with enzalutamide after receiving placebo as randomized treatment. Each patient must not meet any of the following criteria:
- Has taken commercially available enzalutamide (Xtandi);
- Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment
- Known or suspected brain metastasis or active leptomeningeal disease
Key Trial Info
Start Date :
September 16 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2019
Estimated Enrollment :
1717 Patients enrolled
Trial Details
Trial ID
NCT01212991
Start Date
September 16 2010
End Date
February 14 2019
Last Update
March 17 2020
Active Locations (269)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
2
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
3
The University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States, 85719
4
The University of Arizona Cancer Certer-North Campus
Tucson, Arizona, United States, 85719