A Long Term Safety Study With Atrasentan

Abbott166 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

166

Conditions

Prostate Cancer Adenocarcinoma

Interventions

AtrasentanDRUG

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (15)

Prostate Oncology Specialists

Marina del Rey, California, United States

Western Clinical Research, Inc.

Torrance, California, United States

Outcomes

Primary Outcomes

Adverse events

Time frame: 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 Outcomes

Safety and laboratory parameters

Time frame: Every 12 weeks

Data from ClinicalTrials.gov

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