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

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
KOS-862
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Permanente Medical Center
  • Georgia Cancer Specialists
  • University of Maryland Medical System
  • Washington University School of Medicine
  • The Cleveland Clinic Foundation
  • Kaiser Permanente NW Oncology Clinic
  • Oregon Health & Science University
  • Fox Chase Cancer Center
  • University of Washington

Outcomes

Primary Outcome Measures

prostate cancer
prostate-specific antigen (PSA) response

Secondary Outcome Measures

Full Information

First Posted
February 23, 2005
Last Updated
September 16, 2008
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00104130
Brief Title
Study of KOS-862 (Epothilone D) in Metastatic Prostate Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Terminated
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
KOS-862
Primary Outcome Measure Information:
Title
prostate cancer
Title
prostate-specific antigen (PSA) response

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Kaiser Permanente Medical Center
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Georgia Cancer Specialists
City
Tucker
State/Province
Georgia
ZIP/Postal Code
30084
Country
United States
Facility Name
University of Maryland Medical System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63310
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Kaiser Permanente NW Oncology Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

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

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