A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer
NCT ID: NCT00510718
Last Updated: 2019-10-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
140 participants
INTERVENTIONAL
2007-07-23
2018-04-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
NONE
Study Groups
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1
MDV3100
MDV3100
MDV3100 daily until progression or dose-limiting toxicity
Interventions
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MDV3100
MDV3100 daily until progression or dose-limiting toxicity
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration);
3. Progressive disease after medical or surgical castration,
Exclusion Criteria
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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Dana-Farber Cancer Institute (DFCI)
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
MSKCC- Sidney Kimmel Center
New York, New York, United States
Oregon Health & Science University
Portland, Oregon, United States
Investigational Pharmacy Services
Houston, Texas, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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References
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Gibbons JA, Ouatas T, Krauwinkel W, Ohtsu Y, van der Walt JS, Beddo V, de Vries M, Mordenti J. Clinical Pharmacokinetic Studies of Enzalutamide. Clin Pharmacokinet. 2015 Oct;54(10):1043-55. doi: 10.1007/s40262-015-0271-5.
Scher HI, Beer TM, Higano CS, Anand A, Taplin ME, Efstathiou E, Rathkopf D, Shelkey J, Yu EY, Alumkal J, Hung D, Hirmand M, Seely L, Morris MJ, Danila DC, Humm J, Larson S, Fleisher M, Sawyers CL; Prostate Cancer Foundation/Department of Defense Prostate Cancer Clinical Trials Consortium. Antitumour activity of MDV3100 in castration-resistant prostate cancer: a phase 1-2 study. Lancet. 2010 Apr 24;375(9724):1437-46. doi: 10.1016/S0140-6736(10)60172-9. Epub 2010 Apr 14.
Other Identifiers
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C3431009
Identifier Type: OTHER
Identifier Source: secondary_id
S-3100-1-01
Identifier Type: -
Identifier Source: org_study_id
NCT00513812
Identifier Type: -
Identifier Source: nct_alias
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