Determine Effect of Enzalutamide (MDV3100) on the Androgen Signaling Pathway in Correlation With the Anti-tumor Effects of Enzalutamide
NCT ID: NCT01091103
Last Updated: 2018-10-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2010-02-18
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
NONE
Study Groups
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Enzalutamide
Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth. Study drug treatment continued until disease progression, unacceptable toxicity, or withdrawal.
Enzalutamide
Interventions
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Enzalutamide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presence of metastatic disease to the bone
* Ongoing androgen deprivation therapy
Exclusion Criteria
* Metastases in the brain
18 Years
MALE
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Medical Monitor
Role: STUDY_DIRECTOR
Medivation, Inc.
Locations
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MD Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Efstathiou E, Titus M, Wen S, Hoang A, Karlou M, Ashe R, Tu SM, Aparicio A, Troncoso P, Mohler J, Logothetis CJ. Molecular characterization of enzalutamide-treated bone metastatic castration-resistant prostate cancer. Eur Urol. 2015 Jan;67(1):53-60. doi: 10.1016/j.eururo.2014.05.005. Epub 2014 May 29.
Other Identifiers
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C3431017
Identifier Type: OTHER
Identifier Source: secondary_id
CRPC-MDA-1
Identifier Type: -
Identifier Source: org_study_id
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