ZK-Epo Given With Prednisone in Patients With Metastatic Androgen-Independent Prostate Cancer
Information source: Bayer
Information obtained from ClinicalTrials.gov on August 08, 2008
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):
Bayer Study Director, Study Director, Affiliation: Bayer
Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
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: 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 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 Schering Pharma AG, Germany.
Bayer HealthCare Pharmaceuticals, Inc. and Bayer Schering Pharma AG, Germany are the sponsors
of the trial.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
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 Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Cordoba, Argentina; Recruiting
Buenos Aires, Argentina; Recruiting
Fountain Valley, California 92708, United States; Recruiting
Sarasota, Florida 34234, United States; Recruiting
Baltimore, Maryland 21201, United States; Recruiting
Ann Arbor, Michigan 48109-0946, United States; Recruiting
Billings, Montana 59101, United States; Recruiting
Omaha, Nebraska 68198-7680, United States; Recruiting
Farmington, New Mexico 87401-5631, United States; Recruiting
Bronx, New York 10469, United States; Recruiting
Canton, Ohio 44718, United States; Recruiting
Portland, Oregon 16602, United States; Recruiting
Altoona, Pennsylvania 16601, United States; Recruiting
Fort Worth, Texas 76104, United States; Recruiting
Seattle, Washington 20307, United States; Recruiting
Tacoma, Washington 98431, United States; Active, not recruiting
Additional Information
This study is the same study protocol as NCT00430222, with different locations. Click here and search for drug information provided by the FDA. Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
Starting date: July 2006
Ending date: October 2008
Last updated: December 31, 2007
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