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Study of CP-751,871 in Combination With Docetaxel and Prednisone in Patients With Hormone Insensitive Prostate Cancer (HRPC)

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NCT00313781

Last updated on December 16, 2017
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Los Angeles, California, 90048 United States
See other locations
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prostatic Neoplasms
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of metastatic, progressive hormone refractory prostate cancer

- Adequate bone marrow, liver and kidney function

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Previous treatment with chemotherapy

NCT00313781
Pfizer
Completed
Study of CP-751,871 in Combination With Docetaxel and Prednisone in Patients With Hormone Insensitive Prostate Cancer (HRPC)

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Study of CP-751,871 in Combination With Docetaxel and Prednisone in Patients With Hormone Insensitive Prostate Cancer (HRPC)
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
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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostatic Neoplasms
  • Drug: 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).
  • Drug: docetaxel
    Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2.
  • Drug: prednisone
    Prednisone is administered at a dose of 5 mg twice daily.
  • Experimental: 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.
    Interventions:
    • Drug: CP-751,871
    • Drug: docetaxel
    • Drug: prednisone
  • Active Comparator: B
    Interventions:
    • Drug: docetaxel
    • Drug: prednisone
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
204
December 2011
April 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of metastatic, progressive hormone refractory prostate cancer
  • Adequate bone marrow, liver and kidney function

Exclusion Criteria:

  • Previous treatment with chemotherapy
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Germany,   Spain,   Switzerland,   United Kingdom,   United States
Netherlands
 
NCT00313781
A4021011
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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