Study of KOS-862 (Epothilone D) in Metastatic Prostate Ca... | NCT00104130

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

NCT00104130

Sponsor

Bristol-Myers Squibb

Status

Terminated

Last Update Posted

Sep 17, 2008Estimated

Enrollment

Phase

Phase 2

Conditions

Prostate Cancer

Interventions

KOS-862

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Dec 2004

Primary Completion Date

Not provided

Completion Date

Feb 2005

First Submitted Date

Feb 23, 2005

First Submission Date that Met QC Criteria

Feb 23, 2005

First Posted Date

Feb 24, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2008

Last Update Posted Date

Sep 17, 2008Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
KOS-862	Drug

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaiser Permanente Medical Center		Vallejo	California	94589	United States
Georgia Cancer Specialists

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C114026	desoxyepothilone B

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
prostate cancer
prostate-specific antigen (PSA) response