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
18 Years
N/A
Male
Prostate Cancer
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
prostate cancer
Authority:
United States: Food and Drug Administration
Study ID:
KOS-202/NO18401
NCT ID:
NCT00104130
Start Date:
December 2004
Completion Date:
February 2005
Related Keywords:
- Prostate Cancer
- prostate
- Prostatic Neoplasms
Name | Location |
|---|---|
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
| Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
| Georgia Cancer Specialists | Decatur, Georgia 30033 |
| University of Washington | Seattle, Washington 98195 |
| Oregon Health & Science University | Portland, Oregon 97201 |
| Kaiser Permanente Medical Center | Vallejo, California 94589 |
| The Cleveland Clinic Foundation | Cleveland, Ohio |
| University of Maryland Medical System | Baltimore, Maryland 21201 |
| Kaiser Permanente NW Oncology Clinic | Portland, Oregon 97227 |
