Status:
COMPLETED
ZK-Epo Given With Prednisone in Patients With Metastatic Androgen-independent Prostate Cancer
Lead Sponsor:
Bayer
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 p...
Detailed Description
This study has previously been posted by Berlex, Inc. and Schering AG, Germany.Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer Sc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2009
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00350051
Start Date
August 1 2006
End Date
December 21 2009
Last Update
April 8 2021
Active Locations (17)
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1
Fountain Valley, California, United States, 92708
2
Sarasota, Florida, United States, 34237
3
Baltimore, Maryland, United States, 21201
4
Ann Arbor, Michigan, United States, 48109