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


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Male
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:

Interventional

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:

Abbott

Authority:

United States: Food and Drug Administration

Study ID:

M01-304

NCT ID:

NCT00127478

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

Name

Location

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