NCT00104130TerminatedPhase 2
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
Bristol-Myers Squibb18 sites in 1 country53 target enrollmentStarted: December 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 53
- Locations
- 18
- Primary Endpoint
- prostate cancer
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
prostate cancer
prostate-specific antigen (PSA) response
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (18)
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