Safety and Tolerability Study of MDV3100 in Combination With Docetaxel in Men With Advanced Prostate Cancer
NCT ID: NCT01565928
Last Updated: 2019-04-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
23 participants
INTERVENTIONAL
2012-01-24
2018-02-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MDV3100
MDV3100
4 x 40 mg capsules, orally, once per day
Interventions
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MDV3100
4 x 40 mg capsules, orally, once per day
Eligibility Criteria
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Inclusion Criteria
* Men, 18 years of age or older;
* Histologically or cytologically confirmed adenocarcinoma of the prostate;
* Ongoing androgen deprivation therapy
Exclusion Criteria
* Known or suspected brain metastasis;
* History of another malignancy within the previous 5 years;
* Prior treatment with docetaxel-based chemotherapy
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 Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Countries
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Other Identifiers
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C3431002
Identifier Type: OTHER
Identifier Source: secondary_id
MDV3100-06
Identifier Type: -
Identifier Source: org_study_id
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