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

This study has been terminated.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00104130
First received: February 23, 2005
Last updated: September 16, 2008
Last verified: September 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00104130     History of Changes
Other Study ID Numbers: KOS-202/NO18401
Study First Received: February 23, 2005
Last Updated: September 16, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
prostate

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

ClinicalTrials.gov processed this record on November 23, 2014