A Long Term Safety Study With Atrasentan

Phase 2

Completed

• Conditions: Prostate Cancer; Adenocarcinoma

• Registration Number: NCT00127478
• Lead Sponsor: Abbott

Brief Summary

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

Not available

Study Timeline

• Study Start: 2001-07
• Study First Submitted: 2005-08-04
• Study First Submitted QC: 2005-08-04
• Study First Posted: 2005-08-08
• Study Completion: 2007-06
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-28
• Last Update Posted: 2007-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 166

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Adverse events	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

Secondary Outcome Measures

Name	Time	Method
Safety and laboratory parameters	Every 12 weeks

Trial Locations

Locations (15)

Prostate Oncology Specialists; 🇺🇸 Marina Del Rey, California, United States

Western Clinical Research, Inc.; 🇺🇸 Torrance, California, United States

South Florida Medical Research; 🇺🇸 Aventura, Florida, United States

Beth Isreal Medical Center, Phillips Ambulatory Care Ceneter; 🇺🇸 New York, New York, United States

ViaHealth Rochester General Hospital Center for Urology; 🇺🇸 Rochester, New York, United States

Oregon Urology Specialist, Division of Clinical Research; 🇺🇸 Springfield, Oregon, United States

University of Pittsburgh Department of Urology; 🇺🇸 Pittsburgh, Pennsylvania, United States

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada

CroMedia Prime/Prime Trials Vancouver Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Ken Janz MD; 🇨🇦 Burlington, Ontario, Canada

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