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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00350051
• Other study ID #: 91500
• Secondary ID: 307976
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2006
• Est. completion date: December 21, 2009

Study information

• Verified date: April 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00430222

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 21, 2009
• Est. primary completion date: September 24, 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Sagopilone (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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Argentina, 

References & Publications (1)

Beer TM, Smith DC, Hussain A, Alonso M, Wang J, Giurescu M, Roth K, Wang Y. Phase II study of first-line sagopilone plus prednisone in patients with castration-resistant prostate cancer: a phase II study of the Department of Defense Prostate Cancer Clinic — View Citation

Outcome

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

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