Study of CP-751,871 in Combination With Docetaxel and Prednisone in Patients With Hormone Insensitive Prostate Cancer (HRPC)
NCT ID: NCT00313781
Last Updated: 2013-04-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
204 participants
INTERVENTIONAL
2006-05-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
For patients treated with docetaxel and prednisone only, who progress during treatment, CP-751,871 will be added to the regimen to test reversibility of chemoresistance.
CP-751,871
CP-750,871 is administered intravenously at a dose of 20 mg/kg on day 1 of each 21-day cycle (for patient convenience and logistical management, the dose of CP-751,871 may be deferred up to 7 days).
docetaxel
Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2.
prednisone
Prednisone is administered at a dose of 5 mg twice daily.
B
docetaxel
Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2.
prednisone
Prednisone is administered at a dose of 5 mg twice daily.
Interventions
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CP-751,871
CP-750,871 is administered intravenously at a dose of 20 mg/kg on day 1 of each 21-day cycle (for patient convenience and logistical management, the dose of CP-751,871 may be deferred up to 7 days).
docetaxel
Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2.
prednisone
Prednisone is administered at a dose of 5 mg twice daily.
docetaxel
Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2.
prednisone
Prednisone is administered at a dose of 5 mg twice daily.
Eligibility Criteria
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Inclusion Criteria
* Adequate bone marrow, liver and kidney function
Exclusion Criteria
18 Years
MALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
Orange, Ohio, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
Pfizer Investigational Site
Montreal, Quebec, Canada
Pfizer Investigational Site
Montreal, Quebec, Canada
Pfizer Investigational Site
Berlin, , Germany
Pfizer Investigational Site
München, , Germany
Pfizer Investigational Site
A Coruña, A Coruña, Spain
Pfizer Investigational Site
Barcelona, Barcelona, Spain
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, Spain
Pfizer Investigational Site
Sankt Gallen, , Switzerland
Pfizer Investigational Site
Sutton, Surrey, United Kingdom
Pfizer Investigational Site
Glasgow, , United Kingdom
Pfizer Investigational Site
Glasgow, , United Kingdom
Pfizer Investigational Site
Guildford, , United Kingdom
Countries
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References
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de Bono JS, Piulats JM, Pandha HS, Petrylak DP, Saad F, Aparicio LM, Sandhu SK, Fong P, Gillessen S, Hudes GR, Wang T, Scranton J, Pollak MN. Phase II randomized study of figitumumab plus docetaxel and docetaxel alone with crossover for metastatic castration-resistant prostate cancer. Clin Cancer Res. 2014 Apr 1;20(7):1925-34. doi: 10.1158/1078-0432.CCR-13-1869. Epub 2014 Feb 17.
Related Links
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Other Identifiers
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A4021011
Identifier Type: -
Identifier Source: org_study_id
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