Study of CP-751,871 in Combination With Docetaxel and Prednisone in Patients With Hormone Insensitive Prostate Cancer (HRPC)
Information source: Pfizer
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostatic Neoplasms
Intervention: CP-751,871 (Drug); docetaxel (Drug); prednisone (Drug); docetaxel (Drug); prednisone (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer Oncology Clinical Trial Information Service, Phone: 1-877-369-9753, Email: PfizerCancerTrials@emergingmed.com
Summary
To test the efficacy of CP-751,871 combined with docetaxel and prednisone in the treatment
of prostate cancer that is refractory to hormone therapy
Clinical Details
Official title: A Phase 2, Randomized, Non-Comparative, Two-Arm Open Label, Multiple-Center Study Of CP-751,871 In Combination With Docetaxel/Prednisone In Chemotherapy- Naive (Arm A) And Docetaxel/Prednisone Refractory (Arm B) Patients With Hormone Insensitive Prostate Cancer
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Primary outcome: PSA responseAntitumor efficacy measured as Objective Responses using PSA Working Group and RECIST criteria.
Secondary outcome: Safety and tolerabilitySafety,pharmacokinetics,pharmacodynamics of CP-751,871/docetaxel/prednisone progression-free survival Quality of Life Outcomes
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Diagnosis of metastatic, progressive hormone refractory prostate cancer
- Adequate bone marrow, liver and kidney function
Exclusion Criteria:
- Previous treatment with chemotherapy
Locations and Contacts
Pfizer Oncology Clinical Trial Information Service, Phone: 1-877-369-9753, Email: PfizerCancerTrials@emergingmed.com
Pfizer Investigational Site, Berlin 12200, Germany; Active, not recruiting
Pfizer Investigational Site, Muenchen 81675, Germany; Active, not recruiting
Pfizer Investigational Site, A CORUÑA 15006, Spain; Active, not recruiting
Pfizer Investigational Site, BARCELONA 08035, Spain; Active, not recruiting
Pfizer Investigational Site, St. Gallen CH-9007, Switzerland; Active, not recruiting
Pfizer Investigational Site, Guildford GU2 7WG, United Kingdom; Recruiting
Pfizer Investigational Site, Glasgow G12 0YH, United Kingdom; Recruiting
Pfizer Investigational Site, HOSPITALET DE LLOBREGAT, BARCELONA 08907, Spain; Active, not recruiting
Pfizer Investigational Site, Los Angeles, California 90048, United States; Recruiting
Pfizer Investigational Site, New York, New York 10032, United States; Active, not recruiting
Pfizer Investigational Site, Cleveland, Ohio 44195-0001, United States; Completed
Pfizer Investigational Site, Cleveland, Ohio 44106, United States; Recruiting
Pfizer Investigational Site, Orange Village, Ohio 44122, United States; Recruiting
Pfizer Investigational Site, South Euclid, Ohio 44121, United States; Recruiting
Pfizer Investigational Site, Philadelphia, Pennsylvania 19111-2497, United States; Active, not recruiting
Pfizer Investigational Site, Montreal, Quebec H3T 1E2, Canada; Active, not recruiting
Pfizer Investigational Site, Montreal, Quebec H2L 4M1, Canada; Active, not recruiting
Pfizer Investigational Site, Sutton, Surrey SM2 5PT, United Kingdom; Active, not recruiting
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: May 2006
Ending date: December 2010
Last updated: October 13, 2009
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