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

This study has been terminated.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00104130

First received: February 23, 2005

Last updated: September 16, 2008

Last verified: September 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	February 23, 2005
Last Updated Date	September 16, 2008
Start Date ^ICMJE	December 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	prostate cancer prostate-specific antigen (PSA) response
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00104130 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of KOS-862 (Epothilone D) in Metastatic Prostate Cancer
Official Title ^ICMJE	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
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 Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Prostate Cancer
Intervention ^ICMJE	Drug: KOS-862
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	53
Completion Date	February 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00104130
Other Study ID Numbers ^ICMJE	KOS-202/NO18401
Has Data Monitoring Committee
Responsible Party
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Bristol-Myers Squibb
Verification Date	September 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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