A Long Term Safety Study With Atrasentan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00127478
Recruitment Status : Completed
First Posted : August 8, 2005
Last Update Posted : November 29, 2007
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Adenocarcinoma Drug: Atrasentan Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II/III Extension Study to Evaluate the Safety and Tolerability of Atrasentan
Study Start Date : July 2001
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Adverse events [ Time Frame: Every 12 weeks ]
  2. Serious adverse events
  3. Oncology-related events (OREs)
  4. Deaths
  5. Study drug exposure
  6. Change from baseline in Karnofsky performance status
  7. Vital signs
  8. Stratification by treatment group from prior study

Secondary Outcome Measures :
  1. Safety and laboratory parameters [ Time Frame: Every 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00127478

United States, California
Prostate Oncology Specialists
Marina Del Rey, California, United States, 32589
Western Clinical Research, Inc.
Torrance, California, United States, 90505
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
Hoptial de Ranguell Service d'Urologie
Toulouse, Cedex, France, 31043
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
Study Director: Gary Gordon, MD Abbott Identifier: NCT00127478     History of Changes
Other Study ID Numbers: M01-304
First Posted: August 8, 2005    Key Record Dates
Last Update Posted: November 29, 2007
Last Verified: November 2007

Keywords provided by Abbott:
Hormone Refractory Prostate Cancer
Adenocarcinoma of the Prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action