Trial Condition(s):

Prostate Cancer

ZK-Epo given with prednisone in patients with Metastatic androgen-independent prostate cancer

Bayer Identifier:

91500

ClinicalTrials.gov Identifier:

NCT00350051

EudraCT Number:

Not Available

Study Completed

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
53
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Sagopilone (BAY86-5302)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Omaha, United States, 68198-7680

Status
Completed
 
Locations

Investigative Site

Seattle, United States, 98108-1597

Status
Completed
 
Locations

Investigative Site

Fountain Valley, United States, 92708

Status
Completed
 
Locations

Investigative Site

Billings, United States, 59101

Status
Completed
 
Locations

Investigative Site

Portland, United States, 97201

Status
Completed
 
Locations

Investigative Site

Fort Worth, United States, 76104

Status
Completed
 
Locations

Investigative Site

Sarasota, United States, 34237

Status
Completed
 
Locations

Investigative Site

Buenos Aires, Argentina, 1406

Status
Completed
 
Locations

Investigative Site

Córdoba, Argentina, X5016KEH

Status
Completed
 
Locations

Investigative Site

Buenos Aires, Argentina, C1416CRJ

Status
Completed
 
Locations

Investigative Site

Ann Arbor, United States, 48109

Status
Completed
 
Locations

Investigative Site

Baltimore, United States, 21201

Status
Completed
 
Locations

Investigative Site

Canton, United States, 44718

Status
Completed
 
Locations

Investigative Site

Altoona, United States, 16601

Status
Completed
 
Locations

Investigative Site

Buenos Aires, Argentina, C1405DCS

Status
Completed
 
Locations

Investigative Site

Buenos Aires, Argentina, C1280AEB

Status
Completed
 
Locations

Investigative Site

Bronx, United States, 10469

Status
Completed
 

Trial Design