Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Los Angeles, California 90095


Purpose:

This study is being done to evaluate the safety and efficacy of atrasentan in men with non-metastatic hormone-refractory prostate cancer.


Criteria:

Inclusion Criteria: - Have been diagnosed with prostate cancer. - Have a rising PSA while on hormone therapy or following surgical castration. Exclusion Criteria: - Have evidence of distant metastatic disease on screening bone scan or CT scan. - Have received cytotoxic chemotherapy. - Have received opioid or narcotic medications (such as codeine or morphine) or radiation for pain caused by your prostate cancer in the last 6 months.


Study is Available At:


Original ID:

M00-244


NCT ID:

NCT00036556


Secondary ID:


Study Acronym:


Brief Title:

Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer


Official Title:

A Phase III, Randomized Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Male


Minimum Age:

19 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Abbott


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

941


Enrollment Type:

Actual


Overall Contact Information

Official Name:Gary Gordon, M.D.
Study Director
Abbott

Study Dates

Start Date:June 2001
Verification Date:August 2007
Last Changed Date:August 13, 2007
First Received Date:May 10, 2002

Study Outcomes

Outcome Type:Primary Outcome
Measure:Time-to-disease progression will be determined by the time to onset of the earliest of one of the following events: New skeletal lesions, new metastatic extra-skeletal lesions, or an event due to metastatic prostate cancer.
Time Frame:Every 12 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Atrasentan

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Abbott

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.