NCT00127478

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline
Completed

Started Jul 2001

Typical duration for phase_2 prostate-cancer

Geographic Reach
5 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

November 29, 2007

Status Verified

November 1, 2007

First QC Date

August 4, 2005

Last Update Submit

November 28, 2007

Conditions

Prostate CancerAdenocarcinoma

Keywords

Hormone Refractory Prostate CancerAdenocarcinoma of the Prostate

Outcome Measures

Primary Outcomes (8)

  • Adverse events

    Every 12 weeks

  • Serious adverse events

  • Oncology-related events (OREs)

  • Deaths

  • Study drug exposure

  • Change from baseline in Karnofsky performance status

  • Vital signs

  • Stratification by treatment group from prior study

Secondary Outcomes (1)

  • Safety and laboratory parameters

    Every 12 weeks

Interventions

AtrasentanDRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Prostate Oncology Specialists

Marina del Rey, California, 32589, United States

Location

Western Clinical Research, Inc.

Torrance, California, 90505, United States

Location

South Florida Medical Research

Aventura, Florida, 33180, United States

Location

Beth Isreal Medical Center, Phillips Ambulatory Care Ceneter

New York, New York, 10003, United States

Location

ViaHealth Rochester General Hospital Center for Urology

Rochester, New York, 14609, United States

Location

Oregon Urology Specialist, Division of Clinical Research

Springfield, Oregon, 97477, United States

Location

University of Pittsburgh Department of Urology

Pittsburgh, Pennsylvania, 15232, United States

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

CroMedia Prime/Prime Trials Vancouver Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Ken Janz MD

Burlington, Ontario, 3V2CAN, Canada

Location

McMaster Institute of Urology

Hamilton, Ontario, L8N 4A6, Canada

Location

McGill University Health Center Royal VIctoria Hosptial

Montreal, Quebec, H3A1A1, Canada

Location

Hoptial de Ranguell Service d'Urologie

Toulouse, Cedex, 31043, France

Location

University Hospital Rotterdam, Department of Urology

Rotterdam, Netherlands

Location

Leighton Hospital Urology Research Dept., Michael Heal Outpatients Dept.

Crewe, CW1 4QT, United Kingdom

Location

MeSH Terms

Conditions

Prostatic NeoplasmsAdenocarcinoma

Interventions

Atrasentan

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

BenzodioxolesDioxolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrrolidinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Gary Gordon, MD

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 4, 2005

First Posted

August 8, 2005

Study Start

July 1, 2001

Study Completion

June 1, 2007

Last Updated

November 29, 2007

Record last verified: 2007-11

Locations

US(7)GB(1)NL(1)CA(5)FR(1)