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

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

This study has been completed.

Sponsored by:	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

MedlinePlus related topics:

Cancer Prostate Cancer

Drug Information available for:

Atrasentan

U.S. FDA Resources

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

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

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

Keywords provided by Abbott:

Hormone-Refractory, Prostate Cancer

Study placed in the following topic categories:

Prostatic Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on November 20, 2008