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”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2008

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.

Intervention(s) in this Clinical Trial

• Drug: SH-Y03757A (ZK-Epothilone; ZK-219477) with prednisone
  • Chemotherapy for hormone refractory prostate cancer; 16mg/m2 (up to 32mg/m2 max) IV on day 1 or each 21 day cycle for 6 cycles or until progression or unacceptable toxicity.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1

Primary Measures

• PSA Response to treatment with ZK-Epo plus prednisone after 6 cycles
  • Time Frame: at least 28 days post day 21 of last cycle of treatment
    Safety Issue?: No

Secondary Measures

• Safety & Tolerability of ZK-Epo plus prednisone
  • Time Frame: until progression, unknown duration
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Overall Contact: Bayer Clinical Trials Contact  clinical-trials-contact@bayerhealthcare.com

Information obtained from ClinicalTrials.gov on October 06, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00350051

Study ID Number: 91500

ClinicalTrials.gov Identifier: NCT00350051

Health Authority: United States: Food and Drug Administration

This study is the same study protocol as NCT00430222, with different locations.

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