Clinical trial NCT00127478: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Adenocarcinoma
Keywords: Hormone Refractory Prostate Cancer
Adenocarcinoma of the Prostate
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-08-08
Enrollment: 166
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Adverse events
timeFrame: Every 12 weeks
measure: Serious adverse events
measure: Oncology-related events (OREs)
measure: Deaths
measure: Study drug exposure
measure: Change from baseline in Karnofsky performance status
measure: Vital signs
measure: Stratification by treatment group from prior study
Secondary outcomes:
measure: Safety and laboratory parameters
timeFrame: Every 12 weeks
Other outcomes:
Locations:
city: Marina Del Rey
country: United States
facility: Prostate Oncology Specialists
state: California
city: Torrance
country: United States
facility: Western Clinical Research, Inc.
state: California
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: New York
country: United States
facility: Beth Isreal Medical Center, Phillips Ambulatory Care Ceneter
state: New York
city: Rochester
country: United States
facility: ViaHealth Rochester General Hospital Center for Urology
state: New York
city: Springfield
country: United States
facility: Oregon Urology Specialist, Division of Clinical Research
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Department of Urology
state: Pennsylvania
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Vancouver
country: Canada
facility: CroMedia Prime/Prime Trials Vancouver Hospital
state: British Columbia
city: Burlington
country: Canada
facility: Ken Janz MD
state: Ontario
city: Hamilton
country: Canada
facility: McMaster Institute of Urology
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Center Royal VIctoria Hosptial
state: Quebec
city: Toulouse
country: France
facility: Hoptial de Ranguell Service d'Urologie
state: Cedex
city: Rotterdam
country: Netherlands
facility: University Hospital Rotterdam, Department of Urology
city: Crewe
country: United Kingdom
facility: Leighton Hospital Urology Research Dept., Michael Heal Outpatients Dept.
Study officials:
affiliation: Abbott
name: Gary Gordon, MD
role: STUDY_DIRECTOR
References: