Safety and Efficacy of Atrasentan in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure - Tabular View

Tracking Information

First Received Date ^ICMJE

June 3, 2002

Last Updated Date

August 10, 2006

Start Date ^ICMJE

May 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Evaluate the safety and efficacy of 10mg atrasentan in hormone naive subjects, as measured by the rate of rise in PSA.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00038662 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of Atrasentan in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure

Official Title ^ICMJE

A Phase 2 Study Evaluating the Safety and Efficacy of Atrasentan (ABT-627) in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure

Brief Summary

The purpose of this phase II, randomized, double-blind placebo controlled, multi-center study is to evaluate the safety and efficacy of 10 mg atrasentan in hormone naive subjects as measured by rate of rise in the PSA (primary objective).

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Prostatic Neoplasms

Intervention ^ICMJE

Drug: Atrasentan

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

200

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

prostate adenocarcinoma,
radical prostatectomy,
PSA between 0.4 and 5 ng/mL,
PSADT < 1 year

Exclusion Criteria:

previous hormonal therapy,
salvage therapy to the pelvis within 3 months prior to randomization

Gender

Male

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00038662

Responsible Party

Study ID Numbers ^ICMJE

M01-366

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Darryl Sleep, M.D.

Abbott

Information Provided By

Abbott

Verification Date

August 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP