Status:
COMPLETED
Japanese Study of the Combined Administration of Docetaxel With Prednisolone for Metastatic Hormone Refractory Prostate Cancer
Lead Sponsor:
Sanofi
Conditions:
Therapy, Prostatic Neoplasms
Eligibility:
MALE
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety of docetaxel administered every 3 weeks repeatedly for 11 and more cycles and in combination with daily prednisolone for metastatic hormone refracto...
Eligibility Criteria
Inclusion
- Patients who completed the 10 cycles of docetaxel administrations in the preceding XRP6976J/2101 study and wish to continue docetaxel administrations,and who have no alternative therapy for hormone refractory prostate cancer according to the Investigator's judgment.
Exclusion
- Continuation in the study would be detrimental to the patient's well-being
- Development of life-threatening and/or toxic conditions not manageable by symptomatic care, dose reduction, or delay of dosing
- Obvious disease progression (rising prostate specific antigen, any increase of ≥ 20 % in the sum of the measurable lesion in comparison to the nadir value, and progression in non-measurable lesion)
- Patients treated with anti-cancer treatment other than study therapy after completion of 10 cycles of study treatment in the XRP6976J/2101 study
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00723086
Start Date
May 1 2005
End Date
September 1 2008
Last Update
October 1 2009
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Tokyo, Japan