A Long Term Safety Study With Atrasentan

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00127478
• Other study ID #: M01-304
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 4, 2005
• Last updated: November 28, 2007
• Start date: July 2001
• Est. completion date: June 2007

Study information

• Verified date: November 2007
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Atrasentan

Locations

Country	Name	City	State
Canada	Ken Janz MD	Burlington	Ontario
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	McMaster Institute of Urology	Hamilton	Ontario
Canada	McGill University Health Center Royal VIctoria Hosptial	Montreal	Quebec
Canada	CroMedia Prime/Prime Trials Vancouver Hospital	Vancouver	British Columbia
France	Hoptial de Ranguell Service d'Urologie	Toulouse	Cedex
Netherlands	University Hospital Rotterdam, Department of Urology	Rotterdam
United Kingdom	Leighton Hospital Urology Research Dept., Michael Heal Outpatients Dept.	Crewe
United States	South Florida Medical Research	Aventura	Florida
United States	Prostate Oncology Specialists	Marina Del Rey	California
United States	Beth Isreal Medical Center, Phillips Ambulatory Care Ceneter	New York	New York
United States	University of Pittsburgh Department of Urology	Pittsburgh	Pennsylvania
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	Western Clinical Research, Inc.	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

United States,  Canada,  France,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events		Every 12 weeks
Primary	Serious adverse events
Primary	Oncology-related events (OREs)
Primary	Deaths
Primary	Study drug exposure
Primary	Change from baseline in Karnofsky performance status
Primary	Vital signs
Primary	Stratification by treatment group from prior study
Secondary	Safety and laboratory parameters		Every 12 weeks