ZK-Epo Given With Prednisone in Patients With Metastatic Androgen-Independent Prostate Cancer
Information source: Bayer
Information obtained from ClinicalTrials.gov on May 04, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: SH-Y03757A (ZK-Epothilone; ZK-219477) with prednisone (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Berlex Inc., Medical Affairs, Study Director, Affiliation: Phone: 1-888 BERLEX4
Overall contact:
Bayer Schering Pharma AG, Germany, Medical Affairs, Phone: 0800 - 6 66 08 54
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.
Clinical Details
Official title:
Phase 2 Study of ZK-Epothilone (ZK-Epo; ZK219477) Plus Prednisone as First-Line Chemotherapy in Patients With Metastatic Androgen-Independent Prostate Cancer
Study design: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: PSA Response to treatment with ZK-Epo plus prednisone after 6 cycles
Secondary outcome: Safety & Tolerability of ZK-Epo plus prednisone
Detailed description:
This study is also posted by Bayer HealthCare Pharmaceuticals Inc. (formerly Berlex)as NCT00350051.
The sponsor, Bayer Schering Pharma AG, Germany was formerly named Schering AG, Germany.
Eligibility
Minimum age: 18 Years.
Gender(s): Male.
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
Locations and Contacts
Bayer Schering Pharma AG, Germany, Medical Affairs, Phone: 0800 - 6 66 08 54
Córdoba, Argentina; Recruiting
Buenos Aires, Argentina; Recruiting
Additional Information
This study is the same study protocol as NCT00350051, with different locations.
Starting date:
July 2006
Last updated: May 2, 2007
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