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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:
ClinicalTrials.gov Identifier:
NCT00038662
First Posted: June 4, 2002
Last Update Posted: August 15, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
  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
Intervention Model: Parallel Assignment
Masking: Double
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00038662


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

ClinicalTrials.gov Identifier: NCT00038662     History of Changes
Obsolete Identifiers: NCT00084994
Other Study ID Numbers: M01-366
First Submitted: June 3, 2002
First Posted: June 4, 2002
Last Update Posted: August 15, 2006
Last Verified: August 2006

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Atrasentan
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action