A Long Term Safety Study With Atrasentan - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00127478

Purpose

The primary purpose of the study is to evaluate long-term safety and tolerability of atrasentan 10 mg in men with hormone refractory prostate cancer.

Condition	Intervention	Phase
Prostate Cancer Adenocarcinoma	Drug: Atrasentan	Phase II Phase III

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Atrasentan

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Official Title:	A Phase II/III Extension Study to Evaluate the Safety and Tolerability of Atrasentan

Further study details as provided by Abbott:

Primary Outcome Measures:

Secondary Outcome Measures:

Eligibility

Criteria

Inclusion Criteria:

Greater than or equal to 18 years, inclusive;
Subject is currently active in an atrasentan clinical study OR has histologically or cytologically documented diagnosis of prostate adenocarcinoma and is considered hormone refractory;
Karnofsky Performance Score greater than or equal to 60;
Adequate hematologic function and liver function tests;
No New York Heart Association (NYHA) class greater than or equal to 2.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127478

Locations

United States, California
Western Clinical Research, Inc.
Torrance, California, United States, 90505
Prostate Oncology Specialists
Marina Del Rey, California, United States, 32589
United States, Florida
South Florida Medical Research
Aventura, Florida, United States, 33180
United States, New York
Beth Isreal Medical Center, Phillips Ambulatory Care Ceneter
New York, New York, United States, 10003
ViaHealth Rochester General Hospital Center for Urology
Rochester, New York, United States, 14609
United States, Oregon
Oregon Urology Specialist, Division of Clinical Research
Springfield, Oregon, United States, 97477
United States, Pennsylvania
University of Pittsburgh Department of Urology
Pittsburgh, Pennsylvania, United States, 15232
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
CroMedia Prime/Prime Trials Vancouver Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Ken Janz MD
Burlington, Ontario, Canada, 3V2CAN
McMaster Institute of Urology
Hamilton, Ontario, Canada, L8N 4A6
Canada, Quebec
McGill University Health Center Royal VIctoria Hosptial
Montreal, Quebec, Canada, H3A1A1
France, Cedex
Hoptial de Ranguell Service d'Urologie
Toulouse, Cedex, France, 31043
Netherlands
University Hospital Rotterdam, Department of Urology
Rotterdam, Netherlands
United Kingdom
Leighton Hospital Urology Research Dept., Michael Heal Outpatients Dept.
Crewe, United Kingdom, CW1 4QT

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Gary Gordon, MD

Abbott

More Information

Study ID Numbers:	M01-304
Study First Received:	August 4, 2005
Last Updated:	November 28, 2007
ClinicalTrials.gov Identifier:	NCT00127478
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Hormone Refractory Prostate Cancer
Adenocarcinoma of the Prostate

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male

Adenocarcinoma
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009