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A Study for the Treatment of Hormone Refractory Prostate Cancer (HRPC) in Patients Previously Treated With Chemotherapy

Primary Purpose

Prostate Cancer, Cancer of Prostate, Prostatic Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
YM155
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Treatment Efficacy, Treatment Effectiveness, Disease Management, Treatment, Safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Histologically or cytologically confirmed prostate cancer. Prior chemotherapy regimen for prostate cancer Exclusion Criteria: History of other malignancy in the last 5 years Major surgery within the past 21 days

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 22, 2005
Last Updated
June 6, 2012
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma US, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00257478
Brief Title
A Study for the Treatment of Hormone Refractory Prostate Cancer (HRPC) in Patients Previously Treated With Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma US, Inc.

4. Oversight

5. Study Description

Brief Summary
A study for the treatment of hormone refractory prostate cancer (HRPC) in patients previously treated with chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Cancer of Prostate, Prostatic Cancer, Cancer of the Prostate
Keywords
Treatment Efficacy, Treatment Effectiveness, Disease Management, Treatment, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
YM155

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed prostate cancer. Prior chemotherapy regimen for prostate cancer Exclusion Criteria: History of other malignancy in the last 5 years Major surgery within the past 21 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
D. Buell, MD
Organizational Affiliation
Astellas Pharma US, Inc.
Official's Role
Study Director
Facility Information:
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Amsterdam
Country
Netherlands
City
Sutton
State/Province
Surry
ZIP/Postal Code
SM2 5Pt
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study for the Treatment of Hormone Refractory Prostate Cancer (HRPC) in Patients Previously Treated With Chemotherapy

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