Trial Condition(s):
Prostate Cancer
ZK-Epo given with prednisone in patients with Metastatic androgen-independent prostate cancer
Bayer Identifier:
91500
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Omaha, United States, 68198-7680 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seattle, United States, 98108-1597 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fountain Valley, United States, 92708 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Billings, United States, 59101 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Portland, United States, 97201 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fort Worth, United States, 76104 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sarasota, United States, 34237 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, 1406 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Córdoba, Argentina, X5016KEH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, C1416CRJ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ann Arbor, United States, 48109 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Baltimore, United States, 21201 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Canton, United States, 44718 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Altoona, United States, 16601 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, C1405DCS | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, C1280AEB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bronx, United States, 10469 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Phase 2 study of ZK-Epothilone (ZK-Epo; ZK219477) plus prednisone as first-line chemotherapy in patients with metastatic androgen-independent prostate cancer
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- PSA Response to treatment with ZK-Epo plus prednisone after 6 cyclesTimeframe: at least 28 days post day 21 of last cycle of treatment
Secondary Outcome
- Safety & Tolerability of ZK-Epo plus prednisoneTimeframe: until progression, unknown duration
Additional Information
Copyright © Bayer
Powered by
