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

This study has been terminated.

First Received: February 23, 2005 Last Updated: September 16, 2008 History of Changes

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00104130

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 II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Desoxyepothilone B

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

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

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
Oregon Health & Science University
Portland, Oregon, United States, 97239
Kaiser Permanente NW Oncology Clinic
Portland, Oregon, United States, 97227
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

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

Keywords provided by Bristol-Myers Squibb:

prostate

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Epothilones
Neoplasm Metastasis

Urogenital Neoplasms
Genital Diseases, Male
Hormones
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009