ZK-Epo Given With Prednisone 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...
Brief Summary
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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: September 2008
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Sagopilone (ZK 219477) + 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
Outcome Measures for this Clinical Trial
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
- Time Frame: at least 28 days post day 21 of last cycle of treatment
Secondary Measures
- Safety & Tolerability of ZK-Epo plus prednisone
- Time Frame: until progression, unknown duration
Safety Issue?: Yes
- Time Frame: until progression, unknown duration
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Bayer Industry
Overall Clinical Trial Officials and Contacts
Bayer Study Director Study Director Bayer
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
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
Click here and search for drug information provided by the FDA.
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00350051
