Study of KOS-862 (Epothilone D) in Metastatic Prostate Cancer

September 16, 2008 updated by: Bristol-Myers Squibb

A Phase 2 Study of KOS-862 Administered Intravenously Weekly for 3 Weeks Every 4 Weeks, in Patients With Hormone Resistant Prostate Cancer Who Have Progressed Following Initial Therapy for Metastatic Disease

The purpose of this trial is to study KOS-862 in men with metastatic prostate cancer who have failed a docetaxel-containing regimen.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study is a Phase 2, single arm study of KOS-862 in men with metastatic prostate cancer who have failed a docetaxel-containing regimen. PSA response is the primary end-point and objective responses will be checked as available.

Study Type

Interventional

Enrollment

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

  • United States
    • California
      • Vallejo, California, United States, 94589
        • Kaiser Permanente Medical Center
    • Georgia
      • Tucker, Georgia, United States, 30084
        • Georgia Cancer Specialists
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical System
    • Missouri
      • St. Louis, Missouri, United States, 63310
        • Washington University School of Medicine
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente NW Oncology Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • At least 18 years of age.
  • Metastatic disease.
  • One previous treatment including docetaxel (Taxotere).
  • At least 3 weeks since last surgery/radiation/chemotherapy
  • ECOG Performance Status of 0, 1 or 2

Exclusion Criteria:

  • Active brain metastases

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
prostate cancer
prostate-specific antigen (PSA) response

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

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

December 1, 2004

Study Completion

February 1, 2005

Study Registration Dates

First Submitted

February 23, 2005

First Submitted That Met QC Criteria

February 23, 2005

First Posted (Estimate)

February 24, 2005

Study Record Updates

Last Update Posted (Estimate)

September 17, 2008

Last Update Submitted That Met QC Criteria

September 16, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOS-202/NO18401

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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