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

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00350051

Run by

Bayer

People needed

53

Starts

2006-08-01

Expected to finish

2009-12-21

Last updated by the study team

2021-04-08

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Fountain Valley, California, United States
• Study site — Sarasota, Florida, United States
• Study site — Baltimore, Maryland, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Billings, Montana, United States
• Study site — Omaha, Nebraska, United States
• Study site — The Bronx, New York, United States
• Study site — Canton, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Altoona, Pennsylvania, United States
• Study site — Fort Worth, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Córdoba, Argentina

Full record on ClinicalTrials.gov

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