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:

August 4, 2005
August 8, 2005
November 29, 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
Not Provided
Complete list of historical versions of study NCT00127478 on Archive Site
Safety and laboratory parameters [ Time Frame: Every 12 weeks ]
Not Provided
Not Provided
Not Provided
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
Phase 2
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Prostate Cancer
  • Adenocarcinoma
Drug: Atrasentan
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
June 2007
Not Provided

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
Canada,   France,   Netherlands,   United Kingdom,   United States
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
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