A Long Term Safety Study With Atrasentan
This study has been completed.
Sponsor:
Abbott
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00127478
First received: August 4, 2005
Last updated: November 28, 2007
Last verified: November 2007
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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:
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
Keywords provided by Abbott:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 16, 2012
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 Prostatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on October 16, 2012