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

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00104130
Enrollment
53
Registered
2005-02-24
Start date
2004-12-31
Completion date
2005-02-28
Last updated
2008-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate

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.

Interventions

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
prostate cancer
prostate-specific antigen (PSA) response

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026