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

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ClinicalTrials.gov Identifier: NCT00104130
Recruitment Status : Terminated
First Posted : February 24, 2005
Last Update Posted : September 17, 2008
Sponsor:
Information provided by:
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: KOS-862 Phase 2

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  (Clinical Trial)
Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2004
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources




Primary Outcome Measures :
  1. prostate cancer
  2. prostate-specific antigen (PSA) response


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00104130


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

ClinicalTrials.gov Identifier: NCT00104130     History of Changes
Other Study ID Numbers: KOS-202/NO18401
First Posted: February 24, 2005    Key Record Dates
Last Update Posted: September 17, 2008
Last Verified: September 2008

Keywords provided by Bristol-Myers Squibb:
prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases