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Safety and Efficacy of Atrasentan in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00038662
First received: June 3, 2002
Last updated: August 10, 2006
Last verified: August 2006
History of Changes
  Purpose

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).


Condition Intervention Phase
Prostatic Neoplasms
 Drug: Atrasentan
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott:

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

Estimated Enrollment: 200
Study Start Date: May 2002
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00038662

  Show 41 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Darryl Sleep, M.D. Abbott
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00038662     History of Changes
Obsolete Identifiers: NCT00084994
Other Study ID Numbers: M01-366
Study First Received: June 3, 2002
Last Updated: August 10, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013