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A Study of Atrasentan in Men With Metastatic, Hormone-Refractory Prostate Cancer

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.
ClinicalTrials.gov Identifier: NCT00036543
Recruitment Status : Completed
First Posted : May 13, 2002
Last Update Posted : August 15, 2006
Sponsor:
Information provided by:
Abbott

Brief Summary:
This study is being done to evaluate the safety and efficacy of atrasentan in men with metastatic hormone-refractory prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Atrasentan Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of 10 Mg Atrasentan in Men With Metastatic, Hormone-Refractory Prostate Cancer
Study Start Date : May 2001

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. The primary objective of this study is to evaluate safety and efficacy as measured by time-to-disease progression


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:

  • Diagnosis of prostate cancer.
  • Rising PSA while on hormonal therapy or following surgical castration.
  • Documented evidence of metastatic disease.

Exclusion Criteria:

  • Have received cytotoxic chemotherapy.
  • Have received opioid or narcotic medications (such as codeine or morphine) or radiation for pain caused by your prostate cancer in the last 6 months.

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): NCT00036543


  Show 233 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Darryl Sleep, M.D. Abbott

ClinicalTrials.gov Identifier: NCT00036543     History of Changes
Obsolete Identifiers: NCT00026481
Other Study ID Numbers: M00-211
First Posted: May 13, 2002    Key Record Dates
Last Update Posted: August 15, 2006
Last Verified: August 2006

Keywords provided by Abbott:
Hormone-Refractory, Prostate Cancer

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