NCT00104130

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Dec 2004

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
1 country

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2005

Completed
Last Updated

September 17, 2008

Status Verified

September 1, 2008

First QC Date

February 23, 2005

Last Update Submit

September 16, 2008

Conditions

Keywords

prostate

Outcome Measures

Primary Outcomes (2)

  • prostate cancer

  • prostate-specific antigen (PSA) response

Interventions

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Active brain metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Kaiser Permanente Medical Center

Vallejo, California, 94589, United States

Location

Georgia Cancer Specialists

Tucker, Georgia, 30084, United States

Location

University of Maryland Medical System

Baltimore, Maryland, 21201, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63310, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Kaiser Permanente NW Oncology Clinic

Portland, Oregon, 97227, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

desoxyepothilone B

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 23, 2005

First Posted

February 24, 2005

Study Start

December 1, 2004

Study Completion

February 1, 2005

Last Updated

September 17, 2008

Record last verified: 2008-09

Locations