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A Long Term Safety Study With Atrasentan

This study has been completed.
Information provided by:
Abbott Identifier:
First received: August 4, 2005
Last updated: November 28, 2007
Last verified: November 2007

August 4, 2005
November 28, 2007
July 2001
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  • 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
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Complete list of historical versions of study NCT00127478 on Archive Site
Safety and laboratory parameters [ Time Frame: Every 12 weeks ]
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A Long Term Safety Study With Atrasentan
A Phase II/III Extension Study to Evaluate the Safety and Tolerability of Atrasentan
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.
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Phase 2
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Prostate Cancer
  • Adenocarcinoma
Drug: Atrasentan
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2007
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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.
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   France,   Netherlands,   United Kingdom
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Study Director: Gary Gordon, MD Abbott
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP