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

This study has been completed.

First Received: June 3, 2002 Last Updated: August 10, 2006 History of Changes

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00038662

Purpose

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).

Condition	Intervention	Phase
Prostatic Neoplasms	Drug: Atrasentan	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Atrasentan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Abbott:

Primary Outcome Measures:

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

Estimated Enrollment:	200
Study Start Date:	May 2002

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038662

Show 41 Study Locations

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Darryl Sleep, M.D.

Abbott

More Information

No publications provided

Study ID Numbers:	M01-366
Study First Received:	June 3, 2002
Last Updated:	August 10, 2006
ClinicalTrials.gov Identifier:	NCT00038662 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms

Genital Diseases, Male
Hormones
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009