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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Docetaxel; Hormones; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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.