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A Phase II/III Extension Study to Evaluate the Safety and Tolerability of Atrasentan

Phase 2/Phase 3
18 Years
Not Enrolling
Prostate Cancer, Adenocarcinoma

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Trial Information

A Phase II/III Extension Study to Evaluate the Safety and Tolerability of Atrasentan

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse events

Outcome Time Frame:

Every 12 weeks

Principal Investigator

Gary Gordon, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2001

Completion Date:

June 2007

Related Keywords:

  • Prostate Cancer
  • Adenocarcinoma
  • Hormone Refractory Prostate Cancer
  • Adenocarcinoma of the Prostate
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms



South Florida Medical Research Aventura, Florida  33180
Western Clinical Research, Inc. Torrance,, California  90505-4763
Prostate Oncology Specialists Marina Del Rey, California  32589
Beth Isreal Medical Center, Phillips Ambulatory Care Ceneter New York, New York  10003
ViaHealth Rochester General Hospital Center for Urology Rochester, New York  14609
Oregon Urology Specialist, Division of Clinical Research Springfield, Oregon  97477
University of Pittsburgh Department of Urology Pittsburgh, Pennsylvania  15232