Prostate Cancer Clinical Trial

ZK-Epo Given With Prednisone in Patients With Metastatic Androgen-independent Prostate Cancer

Summary

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

53

Study ID:

NCT00350051

Recruitment Status:

Completed

Sponsor:

Bayer

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There are 17 Locations for this study

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Fountain Valley California, 92708, United States

Sarasota Florida, 34237, United States

Baltimore Maryland, 21201, United States

Ann Arbor Michigan, 48109, United States

Billings Montana, 59101, United States

Omaha Nebraska, 68198, United States

Bronx New York, 10469, United States

Canton Ohio, 44718, United States

Portland Oregon, 97201, United States

Altoona Pennsylvania, 16601, United States

Fort Worth Texas, 76104, United States

Seattle Washington, 98108, United States

Buenos Aires Ciudad Auton. De Buenos Aires, C1280, Argentina

Buenos Aires , 1406, Argentina

Buenos Aires , C1405, Argentina

Buenos Aires , C1416, Argentina

Córdoba , X5016, Argentina

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

53

Study ID:

NCT00350051

Recruitment Status:

Completed

Sponsor:


Bayer

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