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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


Phase 2
19 Years
N/A
Not Enrolling
Male
Prostatic Neoplasms

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Darryl Sleep, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Abbott

Authority:

United States: Food and Drug Administration

Study ID:

M01-366

NCT ID:

NCT00038662

Start Date:

May 2002

Completion Date:

Related Keywords:

  • Prostatic Neoplasms
  • Neoplasms
  • Prostatic Neoplasms

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
University of Washington Medical CenterSeattle, Washington  98195-6043
San Diego Urology CenterLa Mesa, California  91942
University of PittsburghPittsburgh, Pennsylvania  15261
Northwestern UniversityChicago, Illinois  60611
Center for Urologic CareWest Reading, Pennsylvania  19611
nTouch Research CorporationDallas, Texas  75230
Alaska Clinical Research Center, LLCAnchorage, Alaska  99508
Urology Centers Of AlabamaHomewood,, Alabama  35205
Arkansas Urologial Associates, PALittle Rock, Arkansas  72205
Clinical Physiology AssociatesFort Myers, Florida  33916
Urologic Specialists Of Oklahoma, Inc.Tulsa,, Oklahoma  74104-5433
Oregon Urology SpecialistsEugene, Oregon  97401
Jeffrey Frankel, M.D.Seattle,, Washington  98166-3059
Western Clinical Research IncTorrance, California  90505
Georgetown University Medical CenterWashington, District of Columbia  20007
Southeastern Urological Center, PATallahassee, Florida  32308
Sheldon Freedman MDLas Vegas, Nevada  89109
VA Medical Center(111)Reno, Nevada  89502
Nevada Urology AssociatesReno, Nevada  89511
Carolinas Medical CentreCharlotte,, North Carolina  28204
Urological Assoc. of LancasterLancaster, Pennsylvania  17604-3200
Salt Lake ResearchSalt Lake City, Utah  84124