A Long Term Safety Study With Atrasentan

November 28, 2007 updated by: Abbott

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

166

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • CroMedia Prime/Prime Trials Vancouver Hospital
    • Ontario
      • Burlington, Ontario, Canada, 3V2CAN
        • Ken Janz MD
      • Hamilton, Ontario, Canada, L8N 4A6
        • McMaster Institute of Urology
    • Quebec
      • Montreal, Quebec, Canada, H3A1A1
        • McGill University Health Center Royal VIctoria Hosptial
  • France
    • Cedex
      • Toulouse, Cedex, France, 31043
        • Hoptial de Ranguell Service d'Urologie
  • Netherlands
      • Rotterdam, Netherlands
        • University Hospital Rotterdam, Department of Urology
  • United Kingdom
      • Crewe, United Kingdom, CW1 4QT
        • Leighton Hospital Urology Research Dept., Michael Heal Outpatients Dept.
  • United States
    • California
      • Marina Del Rey, California, United States, 32589
        • Prostate Oncology Specialists
      • Torrance, California, United States, 90505
        • Western Clinical Research, Inc.
    • Florida
      • Aventura, Florida, United States, 33180
        • South Florida Medical Research
    • New York
      • New York, New York, United States, 10003
        • Beth Isreal Medical Center, Phillips Ambulatory Care Ceneter
      • Rochester, New York, United States, 14609
        • ViaHealth Rochester General Hospital Center for Urology
    • Oregon
      • Springfield, Oregon, United States, 97477
        • Oregon Urology Specialist, Division of Clinical Research
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Department of Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serious adverse events
Vital signs
Study drug exposure
Adverse events
Time Frame: Every 12 weeks
Every 12 weeks
Oncology-related events (OREs)
Deaths
Change from baseline in Karnofsky performance status
Stratification by treatment group from prior study

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and laboratory parameters
Time Frame: Every 12 weeks
Every 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Gary Gordon, MD, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

August 4, 2005

First Submitted That Met QC Criteria

August 4, 2005

First Posted (Estimate)

August 8, 2005

Study Record Updates

Last Update Posted (Estimate)

November 29, 2007

Last Update Submitted That Met QC Criteria

November 28, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M01-304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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