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Clinical Trials/NCT00038662
NCT00038662
Completed
Phase 2

A Phase 2 Study Evaluating the Safety and Efficacy of Atrasentan (ABT-627) in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure

Abbott39 sites in 2 countries200 target enrollmentMay 2002
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ConditionsProstatic Neoplasms
DrugsAtrasentan

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Prostatic Neoplasms
Sponsor
Abbott
Enrollment
200
Locations
39
Primary Endpoint
Evaluate the safety and efficacy of 10mg atrasentan in hormone naive subjects, as measured by the rate of rise in PSA.
Status
Completed
Last Updated
19 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this phase II, randomized, double-blind placebo controlled, multi-center study is to evaluate the safety and efficacy of 10 mg atrasentan in hormone naive subjects as measured by rate of rise in the PSA (primary objective).

Registry
clinicaltrials.gov
Start Date
May 2002
End Date
TBD
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Abbott

Eligibility Criteria

Inclusion Criteria

  • •prostate adenocarcinoma,
  • •radical prostatectomy,
  • •PSA between 0.4 and 5 ng/mL,
  • •PSADT \< 1 year

Exclusion Criteria

  • •previous hormonal therapy,
  • •salvage therapy to the pelvis within 3 months prior to randomization

Outcomes

Primary Outcomes

Evaluate the safety and efficacy of 10mg atrasentan in hormone naive subjects, as measured by the rate of rise in PSA.

Study Sites (39)

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