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Clinical Trials/NCT00127478
NCT00127478CompletedPhase 2

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

Abbott28 sites in 5 countries166 target enrollmentStarted: July 2001Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Abbott
Enrollment
166
Locations
28
Primary Endpoint
Adverse events
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

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.

Exclusion Criteria

  • Not provided

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(Every 12 weeks)

Investigators

Sponsor
Abbott
Sponsor Class
Industry

Study Sites (28)

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