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

Phase 2 Study of ZK-Epothilone (ZK-Epo; ZK219477) Plus Prednisone as First-line Chemotherapy in Patients With Metastatic Androgen-independent Prostate Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00350051

Enrollment

Registered

2006-07-10

Start date

2006-08-01

Completion date

2009-12-21

Last updated

2021-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate cancer, Metastatic androgen-independent prostate cancer

Brief 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.

Detailed 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.

Interventions

DRUGSagopilone (ZK 219477) + prednisone

Chemotherapy for hormone refractory prostate cancer; 16mg/m2 (up to 32mg/m2 max) IV on day 1 or each 21 day cycle for 6 cycles or until progression or unacceptable toxicity.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
PSA Response to treatment with ZK-Epo plus prednisone after 6 cycles	at least 28 days post day 21 of last cycle of treatment

Secondary

Measure	Time frame
Safety & Tolerability of ZK-Epo plus prednisone	until progression, unknown duration

Countries

Argentina, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026