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

Bayer

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Sagopilone (ZK 219477) + prednisone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00350051

307976 (Other Identifier)

91500

Details and patient eligibility

About

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.

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.

Enrollment: 53 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Sagopilone (ZK 219477) + prednisone