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

April 6, 2021 updated by: Bayer

Phase 2 Study of ZK-Epothilone (ZK-Epo; ZK219477) Plus Prednisone as First-line Chemotherapy 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1406
      • Buenos Aires, Argentina, C1416CRJ
      • Buenos Aires, Argentina, C1405DCS
      • Córdoba, Argentina, X5016KEH
    • Ciudad Auton. De Buenos Aires
      • Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1280AEB
  • United States
    • California
      • Fountain Valley, California, United States, 92708
    • Florida
      • Sarasota, Florida, United States, 34237
    • Maryland
      • Baltimore, Maryland, United States, 21201
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
    • Montana
      • Billings, Montana, United States, 59101
    • Nebraska
      • Omaha, Nebraska, United States, 68198-7680
    • New York
      • Bronx, New York, United States, 10469
    • Ohio
      • Canton, Ohio, United States, 44718
    • Oregon
      • Portland, Oregon, United States, 97201
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16601
    • Texas
      • Fort Worth, Texas, United States, 76104
    • Washington
      • Seattle, Washington, United States, 98108-1597

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at least 28 days post day 21 of last cycle of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2006

Primary Completion (Actual)

September 24, 2008

Study Completion (Actual)

December 21, 2009

Study Registration Dates

First Submitted

July 7, 2006

First Submitted That Met QC Criteria

July 7, 2006

First Posted (Estimate)

July 10, 2006

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91500
  • 307976 (Other Identifier: Company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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