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

August 4, 2005
November 28, 2007
July 2001
Not Provided
  • 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 ClinicalTrials.gov 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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
166
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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   France,   Netherlands,   United Kingdom
 
NCT00127478
M01-304
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Abbott
Not Provided
Study Director: Gary Gordon, MD Abbott
Abbott
November 2007

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