ClinicalTrials.gg
CompletedNCT00127478Updated Nov 29, 2007

A Long Term Safety Study With Atrasentan

A Phase 2/3 interventional study of Atrasentan in Prostate Cancer and Adenocarcinoma, sponsored by Abbott. Completed at 15 sites in 5 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-11-29.

Sponsored by Abbott · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
166
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
01

Study summary

The primary purpose of the study is to evaluate long-term safety and tolerability of atrasentan 10 mg in men with hormone refractory prostate cancer.

02

Conditions studied

  • Prostate Cancer
  • Adenocarcinoma

Keywords

  • Hormone Refractory Prostate Cancer
  • Adenocarcinoma of the Prostate
03

In context

Prostatic Neoplasms

6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.

This study's enrollment of 166 is above the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Abbott is the lead sponsor of 361 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Greater than or equal to 18 years, inclusive;
  • Subject is currently active in an atrasentan clinical study OR has histologically or cytologically documented diagnosis of prostate adenocarcinoma and is considered hormone refractory;
  • Karnofsky Performance Score greater than or equal to 60;
  • Adequate hematologic function and liver function tests;
  • No New York Heart Association (NYHA) class greater than or equal to 2.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
166 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

  1. Adverse events

    Time frame: Every 12 weeks

  2. Serious adverse events

  3. Oncology-related events (OREs)

  4. Deaths

  5. Study drug exposure

  6. Change from baseline in Karnofsky performance status

  7. Vital signs

  8. Stratification by treatment group from prior study

Secondary outcomes

  1. Safety and laboratory parameters

    Time frame: Every 12 weeks

07

Study locations

15 sites
  • Prostate Oncology Specialists
    Marina del Rey, California 32589, United States
  • Western Clinical Research, Inc.
    Torrance, California 90505, United States
  • South Florida Medical Research
    Aventura, Florida 33180, United States
  • Beth Isreal Medical Center, Phillips Ambulatory Care Ceneter
    New York, New York 10003, United States
  • ViaHealth Rochester General Hospital Center for Urology
    Rochester, New York 14609, United States
  • Oregon Urology Specialist, Division of Clinical Research
    Springfield, Oregon 97477, United States
  • University of Pittsburgh Department of Urology
    Pittsburgh, Pennsylvania 15232, United States
  • Cross Cancer Institute
    Edmonton, Alberta T6G 1Z2, Canada
  • CroMedia Prime/Prime Trials Vancouver Hospital
    Vancouver, British Columbia V5Z 1M9, Canada
  • Ken Janz MD
    Burlington, Ontario 3V2CAN, Canada
  • McMaster Institute of Urology
    Hamilton, Ontario L8N 4A6, Canada
  • McGill University Health Center Royal VIctoria Hosptial
    Montreal, Quebec H3A1A1, Canada
  • Hoptial de Ranguell Service d'Urologie
    Toulouse, Cedex 31043, France
  • University Hospital Rotterdam, Department of Urology
    Rotterdam, Netherlands
  • Leighton Hospital Urology Research Dept., Michael Heal Outpatients Dept.
    Crewe, CW1 4QT, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00127478
Lead sponsor
Abbott
First posted
Aug 8, 2005
Start date
Jul 2001
Completion
Jun 2007
Last update
Nov 29, 2007

Study contacts

Gary Gordon, MD
study director · Abbott
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.

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