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A Long Term Safety Study With Atrasentan

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00127478
First received: August 4, 2005
Last updated: November 28, 2007
Last verified: November 2007
History of Changes
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II/III Extension Study to Evaluate the Safety and Tolerability of Atrasentan

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott:

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

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

Enrollment: 166
Study Start Date: July 2001
Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
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
France
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

No publications provided

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

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

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Cystic, Mucinous, and Serous
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 22, 2013