Status:
COMPLETED
PhII One Label Non-Comparative Trial in Metastatic Hormone Refractory Prostate Cancer in Combination With Prednisolone
Lead Sponsor:
Sanofi
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
20-74 years
Phase:
PHASE2
Brief Summary
* 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
Eligibility Criteria
Inclusion
- Men with prostate adenocarcinoma with at least one metastatic lesion which is measurable and who progressed after prior hormonal therapy.
Exclusion
- Body temperature \> 38 degree centigrade.
- Prior radiotherapy to \> 25% of bone marrow.
- Prior isotope therapy and/or brachytherapy
- Prior gene therapy.
- Active double cancer.
- Known brain or leptomeningeal involvement.
- History of hypersensitivity reaction to drug
- Other serious illness or medical condition
- Subjects whom the investigators consider inappropriate from social or medical aspects.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00291005
Start Date
August 1 2004
Last Update
March 27 2009
Active Locations (1)
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1
Sanofi-Aventis
Tokyo, Japan