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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00104130
First Posted: February 24, 2005
Last Update Posted: September 17, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
  Purpose
The purpose of this trial is to study KOS-862 in men with metastatic prostate cancer who have failed a docetaxel-containing regimen.

Condition Intervention Phase
Prostate Cancer Drug: KOS-862 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • prostate cancer
  • prostate-specific antigen (PSA) response

Estimated Enrollment: 53
Study Start Date: December 2004
Estimated Study Completion Date: February 2005
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00104130     History of Changes
Other Study ID Numbers: KOS-202/NO18401
First Submitted: February 23, 2005
First Posted: February 24, 2005
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