A Study of Atrasentan in Men With Metastatic, Hormone-Refractory Prostate Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

May 10, 2002

Last Updated Date

August 10, 2006

Start Date ^ICMJE

May 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The primary objective of this study is to evaluate safety and efficacy as measured by time-to-disease progression

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00036543 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Study of Atrasentan in Men With Metastatic, Hormone-Refractory Prostate Cancer

Official Title ^ICMJE

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of 10 Mg Atrasentan in Men With Metastatic, Hormone-Refractory Prostate Cancer

Brief Summary

This study is being done to evaluate the safety and efficacy of atrasentan in men with metastatic hormone-refractory prostate cancer.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Drug: Atrasentan

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1000

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of prostate cancer.
Rising PSA while on hormonal therapy or following surgical castration.
Documented evidence of metastatic disease.

Exclusion Criteria:

Have received cytotoxic chemotherapy.
Have received opioid or narcotic medications (such as codeine or morphine) or radiation for pain caused by your prostate cancer in the last 6 months.

Gender

Male

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Austria, Belgium, Canada, France, Germany, Greece, Ireland, Italy, Netherlands, New Zealand, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00036543

Responsible Party

Study ID Numbers ^ICMJE

M00-211

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Darryl Sleep, M.D.

Abbott

Information Provided By

Abbott

Verification Date

August 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP