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PhII One Label Non-Comparative Trial in Metastatic Hormone Refractory Prostate Cancer in Combination With Prednisolone

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: February 10, 2006
Last updated: March 26, 2009
Last verified: March 2009

February 10, 2006
March 26, 2009
August 2004
Not Provided
Overall tumor response rate by Response Evaluation Criteria in Solid Tumor (RECIST)
Same as current
Complete list of historical versions of study NCT00291005 on Archive Site
Overall response rate by modified WHO criteria, PSA response rate, safety
Same as current
Not Provided
Not Provided
PhII One Label Non-Comparative Trial in Metastatic Hormone Refractory Prostate Cancer in Combination With Prednisolone
A Multicenter Phase II Open Label Non-Comparative Trial of RP56976 Administered Every Three Weeks in Combination With Daily Prednisolone for Metastatic Hormone Refractory Prostate Cancer
  • To evaluate the overall tumor response rate in subjects with metastatic hormone refractory prostate cancer
  • To evaluate PSA (tumor marker) response rate
  • To evaluate safety
Not Provided
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostatic Neoplasms
Drug: ARD6562, Docetaxel
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
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Inclusion Criteria:

  • Men with prostate adenocarcinoma with at least one metastatic lesion which is measurable and who progressed after prior hormonal therapy.

Exclusion Criteria:

  • 1.Body temperature > 38 degree centigrade.
  • 2.Prior radiotherapy to > 25% of bone marrow.
  • 3.Prior isotope therapy and/or brachytherapy
  • 4.Prior gene therapy.
  • 5.Active double cancer.
  • 6.Known brain or leptomeningeal involvement.
  • 7.History of hypersensitivity reaction to drug
  • 8.Other serious illness or medical condition
  • 9.Subjects whom the investigators consider inappropriate from social or medical aspects.
20 Years to 74 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
ARD6562, XRP6976J/2101
Not Provided
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Study Chair: Atsushi NAKAMURA CSD, PL / TA-Oncology
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP