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Completed

NCT Number: NCT00350051

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

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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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sagopilone (ZK 219477) + prednisone

Drug

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.

Primary outcomes

  1. PSA Response to treatment with ZK-Epo plus prednisone after 6 cycles

    Time frame: at least 28 days post day 21 of last cycle of treatment

Secondary outcomes

  1. Safety & Tolerability of ZK-Epo plus prednisone

    Time frame: until progression, unknown duration

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Jul 10, 2006
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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