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

This study has been completed.

First Received on May 10, 2002. Last Updated on 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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Criteria

Inclusion Criteria:

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

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Darryl Sleep, M.D.

Abbott

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00036543 History of Changes
Obsolete Identifiers:	NCT00026481
Other Study ID Numbers:	M00-211
Study First Received:	May 10, 2002
Last Updated:	August 10, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Hormone-Refractory, Prostate Cancer

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male

Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 13, 2012