A Long Term Safety Study With Atrasentan

Sponsor

Abbott (Industry)

Overall Status

Completed

CT.gov ID

NCT00127478

Collaborator

(none)

166

Enrollment

Locations

Duration (Months)

11.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Adenocarcinoma	Drug: Atrasentan	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

166 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2001

Actual Study Completion Date :

Jun 1, 2007

Outcome Measures

Primary Outcome Measures

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

Safety and laboratory parameters [Every 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

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