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

This study has been completed.

First Received on May 10, 2002. Last Updated on August 13, 2007 History of Changes

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00036556

Purpose

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

Condition	Intervention	Phase
Prostatic Neoplasms	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 III, Randomized Study of Atrasentan in Men With Non-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:

Time-to-disease progression will be determined by the time to onset of the earliest of one of the following events: New skeletal lesions, new metastatic extra-skeletal lesions, or an event due to metastatic prostate cancer. [ Time Frame: Every 12 weeks ]

Enrollment:	941
Study Start Date:	June 2001

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Have evidence of distant metastatic disease on screening bone scan or CT scan.
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: NCT00036556

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Gary Gordon, M.D.

Abbott

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00036556 History of Changes
Obsolete Identifiers:	NCT00026455
Other Study ID Numbers:	M00-244
Study First Received:	May 10, 2002
Last Updated:	August 13, 2007
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Hormone-Refractory Prostate Cancer

Additional relevant MeSH terms:

Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
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 12, 2012