PhII One Label Non-Comparative Trial in Metastatic Hormone Refractory Prostate Cancer in Combination With Prednisolone
Phase 2
Completed
- Conditions
- Prostatic Neoplasms
- Registration Number
- NCT00291005
- Lead Sponsor
- Sanofi
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 42
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Overall tumor response rate by Response Evaluation Criteria in Solid Tumor (RECIST)
- Secondary Outcome Measures
Name Time Method Overall response rate by modified WHO criteria, PSA response rate, safety
Trial Locations
- Locations (1)
Sanofi-Aventis
🇯🇵Tokyo, Japan