A Study to Evaluate the Safety and Efficacy of Enzalutamide in Chemotherapy-Naïve, Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
NCT ID: NCT01663415
Last Updated: 2012-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2012-08-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Enzalutamide
Enzalutamide
oral
Interventions
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Enzalutamide
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Castrate testosterone level
* Maintenance of surgical or medical castration for duration of study
* Radiographically visible metastatic disease
* Symptomatic from prostate cancer
* Eastern Cooperative Oncology Group (ECOG) 0-2
* Life expectancy \>=6 months
Exclusion Criteria
* Prior cytotoxic chemotherapy for prostate cancer
* Prior use of ketoconazole or abiraterone acetate or other investigational agent that blocks androgen synthesis or targets androgen receptor
* History of seizure or condition that may predispose to seizure
* History of loss of consciousness or transient ischemic attack within 12 months
* Clinically significant cardiovascular disease
MALE
No
Sponsors
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Medivation, Inc.
INDUSTRY
Astellas Pharma Global Development, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Senior Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Countries
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Other Identifiers
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9785-UC-0001
Identifier Type: -
Identifier Source: org_study_id