Los Angeles, California 90095

  • Prostate Cancer

Purpose:

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


Criteria:

Inclusion Criteria: - Diagnosis of prostate cancer. - Rising PSA while on hormonal therapy or following surgical castration. - Documented evidence of metastatic disease. Exclusion Criteria: - 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:

M00-211


NCT ID:

NCT00036543


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of 10 Mg Atrasentan in Men With 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:

0


Number of Groups:

0


Total Enrollment:

1000


Enrollment Type:


Overall Contact Information

Official Name:Darryl Sleep, M.D.
Study Director
Abbott

Study Dates

Start Date:May 2001
Verification Date:August 2006
Last Changed Date:August 10, 2006
First Received Date:May 10, 2002

Study Outcomes

Outcome Type:Primary Outcome
Measure:The primary objective of this study is to evaluate safety and efficacy as measured by time-to-disease progression
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: April 07, 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.