A Long Term Safety Study With Atrasentan

NCT ID: NCT00127478

Last Updated: 2007-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-31

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer Adenocarcinoma

Keywords

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Hormone Refractory Prostate Cancer Adenocarcinoma of the Prostate

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Atrasentan

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Principal Investigators

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Gary Gordon, MD

Role: STUDY_DIRECTOR

Abbott

Locations

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Prostate Oncology Specialists

Marina del Rey, California, United States

Site Status

Western Clinical Research, Inc.

Torrance, California, United States

Site Status

South Florida Medical Research

Aventura, Florida, United States

Site Status

Beth Isreal Medical Center, Phillips Ambulatory Care Ceneter

New York, New York, United States

Site Status

ViaHealth Rochester General Hospital Center for Urology

Rochester, New York, United States

Site Status

Oregon Urology Specialist, Division of Clinical Research

Springfield, Oregon, United States

Site Status

University of Pittsburgh Department of Urology

Pittsburgh, Pennsylvania, United States

Site Status

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

CroMedia Prime/Prime Trials Vancouver Hospital

Vancouver, British Columbia, Canada

Site Status

Ken Janz MD

Burlington, Ontario, Canada

Site Status

McMaster Institute of Urology

Hamilton, Ontario, Canada

Site Status

McGill University Health Center Royal VIctoria Hosptial

Montreal, Quebec, Canada

Site Status

Hoptial de Ranguell Service d'Urologie

Toulouse, Cedex, France

Site Status

University Hospital Rotterdam, Department of Urology

Rotterdam, , Netherlands

Site Status

Leighton Hospital Urology Research Dept., Michael Heal Outpatients Dept.

Crewe, , United Kingdom

Site Status

Countries

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United States Canada France Netherlands United Kingdom

Other Identifiers

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M01-304

Identifier Type: -

Identifier Source: org_study_id