Back to resultsA Long Term Safety Study With Atrasentan
Primary Purpose
Prostate Cancer, Adenocarcinoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Atrasentan
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Hormone Refractory Prostate Cancer, Adenocarcinoma of the Prostate
Eligibility Criteria
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.
Sites / Locations
- Prostate Oncology Specialists
- Western Clinical Research, Inc.
- South Florida Medical Research
- Beth Isreal Medical Center, Phillips Ambulatory Care Ceneter
- ViaHealth Rochester General Hospital Center for Urology
- Oregon Urology Specialist, Division of Clinical Research
- University of Pittsburgh Department of Urology
- Cross Cancer Institute
- CroMedia Prime/Prime Trials Vancouver Hospital
- Ken Janz MD
- McMaster Institute of Urology
- McGill University Health Center Royal VIctoria Hosptial
- Hoptial de Ranguell Service d'Urologie
- University Hospital Rotterdam, Department of Urology
- Leighton Hospital Urology Research Dept., Michael Heal Outpatients Dept.
Outcomes
Primary Outcome Measures
Adverse events
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00127478
Brief Title
A Long Term Safety Study With Atrasentan
Official Title
A Phase II/III Extension Study to Evaluate the Safety and Tolerability of Atrasentan
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Adenocarcinoma
Keywords
Hormone Refractory Prostate Cancer, Adenocarcinoma of the Prostate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Atrasentan
Primary Outcome Measure Information:
Title
Adverse events
Time Frame
Every 12 weeks
Title
Serious adverse events
Title
Oncology-related events (OREs)
Title
Deaths
Title
Study drug exposure
Title
Change from baseline in Karnofsky performance status
Title
Vital signs
Title
Stratification by treatment group from prior study
Secondary Outcome Measure Information:
Title
Safety and laboratory parameters
Time Frame
Every 12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Gordon, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Prostate Oncology Specialists
City
Marina Del Rey
State/Province
California
ZIP/Postal Code
32589
Country
United States
Facility Name
Western Clinical Research, Inc.
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Beth Isreal Medical Center, Phillips Ambulatory Care Ceneter
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
ViaHealth Rochester General Hospital Center for Urology
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Oregon Urology Specialist, Division of Clinical Research
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
University of Pittsburgh Department of Urology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
CroMedia Prime/Prime Trials Vancouver Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Ken Janz MD
City
Burlington
State/Province
Ontario
ZIP/Postal Code
3V2CAN
Country
Canada
Facility Name
McMaster Institute of Urology
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
McGill University Health Center Royal VIctoria Hosptial
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A1A1
Country
Canada
Facility Name
Hoptial de Ranguell Service d'Urologie
City
Toulouse
State/Province
Cedex
ZIP/Postal Code
31043
Country
France
Facility Name
University Hospital Rotterdam, Department of Urology
City
Rotterdam
Country
Netherlands
Facility Name
Leighton Hospital Urology Research Dept., Michael Heal Outpatients Dept.
City
Crewe
ZIP/Postal Code
CW1 4QT
Country
United Kingdom
12. IPD Sharing Statement
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A Long Term Safety Study With Atrasentan
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