ZK-Epo Given With Prednisone in Patients With Metastatic Androgen-independent Prostate Cancer

• Status: Completed
• Trial end date: 2009-12-21
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) given with prednisone in patients with androgen-independent prostate cancer, who have not had previous chemotherapy, is safe and helps to decrease PSA (Prostate-specific antigen) levels.

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

Details

• Lead Sponsor: Bayer
• Treatments: Androgens; Prednisone; Sagopilone

Criteria

Inclusion Criteria:

• Must have evidence of confirmed metastatic prostate cancer

• Serum testosterone must be less than 50 ng/mL

• Disease must be progressing despite anti-androgen therapy

• PSA level must be elevated

• Additional criteria determined at screening visit

Exclusion Criteria:

• Any previous cytotoxic chemotherapy for prostate cancer

• Use of any investigational drug in the last 4 weeks

• Symptomatic brain tumors requiring radiation to the brain

• Active infection

• Additional criteria determined at screening visit