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Atrasentan in Treating Patients With 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. Identifier: NCT00046943
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 21, 2011
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase III trial to determine the effectiveness of atrasentan in treating patients who have prostate cancer that has not responded to hormone therapy.

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

Detailed Description:


  • Determine the safety of atrasentan in patients with hormone-refractory prostate cancer.
  • Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral atrasentan once daily for 3 years in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month and then every 3 months for 2 years.

PROJECTED ACCRUAL: Approximately 1,400 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Extension Study to Evaluate the Safety of 10 mg Atrasentan in Men With Hormone-Refractory Prostate Cancer
Study Start Date : September 2002
Actual Primary Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Diagnosis of hormone-refractory prostate cancer
  • Completed protocol ABBOTT-M00-211 or ABBOTT-M00-244 within the past 30 days

    • Disease progression OR
    • Active in trial when double-blind treatment period ended



  • 19 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • Not specified


  • WBC at least 3,000/mm3
  • Absolute neutrophil count greater than 1,000/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin at least 9 g/dL


  • Bilirubin less than 1.5 mg/dL
  • AST and ALT no greater than 1.5 times upper limit of normal


  • Creatinine clearance at least 40 mL/min


  • No New York Heart Association class II-IV heart disease


  • No significant pulmonary disease requiring chronic or pulse steroid therapy within the past 3 months


  • Fertile patients must use 2 effective methods of contraception (1 must be barrier contraception) during and for 8 weeks after study
  • No reason that would preclude study
  • No significant comorbid condition that would preclude study


Biologic therapy

  • Not specified


  • At least 4 weeks since other prior cytotoxic chemotherapy
  • No other concurrent cytotoxic chemotherapy

Endocrine therapy

  • Not specified


  • At least 4 weeks since prior radionuclides
  • No concurrent radionuclides


  • Not specified


  • At least 4 weeks since prior investigational agents
  • No concurrent antiretroviral therapy for HIV-positive patients
  • No concurrent participation in another investigational study

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 identifier (NCT number): NCT00046943

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United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1738
Sponsors and Collaborators
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OverallOfficial: Gary Gordon, MD, PhD Abbott
Layout table for additonal information Identifier: NCT00046943    
Other Study ID Numbers: CDR0000257127
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 21, 2011
Last Verified: September 2003
Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
recurrent prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Antineoplastic Agents
Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action