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

This study has been completed.

First Received: May 10, 2002 Last Updated: August 10, 2006 History of Changes

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00036543

Purpose

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

Condition	Intervention	Phase
Prostate Cancer	Drug: Atrasentan	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Atrasentan

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

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

Estimated Enrollment:	1000
Study Start Date:	May 2001

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036543

Show 234 Study Locations

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Darryl Sleep, M.D.

Abbott

More Information

No publications provided

Study ID Numbers:	M00-211
Study First Received:	May 10, 2002
Last Updated:	August 10, 2006
ClinicalTrials.gov Identifier:	NCT00036543 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Hormone-Refractory, Prostate Cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Urogenital Neoplasms
Genital Diseases, Male
Hormones
Prostatic Neoplasms
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009