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OpenTrials
Completed

NCT Number: NCT00127478

A Long Term Safety Study With Atrasentan

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.

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Key information

Conditions

Prostate Cancer Adenocarcinoma Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Cross Cancer Institute, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Atrasentan

Drug

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

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

A Phase II/III Extension Study to Evaluate the Safety and Tolerability of Atrasentan

Important dates

Study start
2001
Study completion
2007
First posted
Aug 8, 2005
Registry last updated
Nov 29, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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