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

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ClinicalTrials.gov Identifier: NCT00038662
Recruitment Status : Completed
First Posted : June 4, 2002
Last Update Posted : August 15, 2006
Sponsor:
Information provided by:
Abbott

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).

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Atrasentan Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
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
Study Start Date : May 2002

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


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
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

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


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

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

Additional relevant MeSH terms:
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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
Antineoplastic Agents
Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action