Study of KOS-862 (Epothilone D) in Metastatic Prostate Cancer
This study has been terminated.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00104130
First received: February 23, 2005
Last updated: September 16, 2008
Last verified: September 2008
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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 |
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
| 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 Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013