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

EU CT 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
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Investigative Site

Omaha, United States, 68198-7680

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Seattle, United States, 98108-1597

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Fountain Valley, United States, 92708

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Billings, United States, 59101

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Portland, United States, 97201

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Fort Worth, United States, 76104

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Sarasota, United States, 34237

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Buenos Aires, Argentina, 1406

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Córdoba, Argentina, X5016KEH

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Buenos Aires, Argentina, C1416CRJ

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Ann Arbor, United States, 48109

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Baltimore, United States, 21201

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Canton, United States, 44718

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Altoona, United States, 16601

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Investigative Site

Buenos Aires, Argentina, C1405DCS

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Investigative Site

Buenos Aires, Argentina, C1280AEB

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Investigative Site

Bronx, United States, 10469

Trial Design