Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy



Status:Completed
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/13/2018
Start Date:September 30, 2009
End Date:November 2, 2017

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Trial Summary
Trial Overview
Inclusion Criteria

Affirm: A Multinational Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy And Safety Study Of Oral Mdv3100 In Patients With Progressive Castration-resistant Prostate Cancer Previously Treated With Docetaxel Based Chemotherapy

This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients
with castration-resistant prostate cancer who have been previously treated with
docetaxel-based chemotherapy.


Inclusion Criteria:

- Progressive prostate cancer

- Medical or surgical castration with testosterone less than 50 ng/dl

- One or two prior chemotherapy regimens. At least one chemotherapy regimen must have
contained docetaxel

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Adequate bone marrow, hepatic, and renal function

- Able to swallow the study drug and comply with study requirements

- Informed consent

Exclusion Criteria:

- Metastases in the brain or active epidural disease

- Another malignancy within the previous 5 years

- Clinically significant cardiovascular disease

- Gastrointestinal disorder affecting absorption
We found this trial at
92
sites
Tennessee Oncology, PLLC
Smyrna, Tennessee 37167
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland 21231
410-955-6190
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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University of Alabama at Birmingham
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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Beth Israel Deaconess Medical Center
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
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Roswell Park Cancer Institute
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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University of Chicago
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
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Vanderbilt University Medical Center
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Hospital of the University of Pennsylvania
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
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UCSF Helen Diller Family Comprehensive Cancer Center
1600 Divisadero Street
San Francisco, California 94115
888.689.8273
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Seattle Cancer Care Alliance
825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
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New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico 87109
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Peachtree Hematology-Oncology Consultants
Atlanta, Georgia 30318
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Palm Beach Cancer Institute
5507 South Congress Avenue
Atlantis, Florida 33462
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Research Pharmacist
Aurora, Colorado 80045
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University of Colorado Denver, Anschutz Cancer Pavilion
13001 East 17th Place
Aurora, Colorado 80045
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Johns Hopkins Hospital
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
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Tower Cancer Research Foundation, Tower Hematology Oncology Medical Group
9090 Wilshire Boulevard
Beverly Hills, California 90211
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USC Westside Prostate Cancer Center
Beverly Hills, California
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Massachusetts General Hospital (MGH)
Boston, Massachusetts 02114
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Brigham and Women's Hospital (BWH)
Boston, Massachusetts 02115
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Dana-Farber Cancer Institute
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
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Instituto Medico de Asistencia e Investigaciones S.A (IMAI Research)
Buenos Aires, AR
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Hollings Cancer Center
Charleston, South Carolina 29425
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Medical University of South Carolina
Charleston, South Carolina 29425
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Tennessee Oncology PLLC
Chattanooga, Tennessee 37404
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Virginia Oncology Associates
Chesapeake, Virginia 23320
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University of Chicago Medical Center
5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
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Siteman Cancer Center - West County
Creve Coeur, Missouri 63141
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Parkland Health and Hospital System
Dallas, Texas 75235
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Texas Oncology Sammons Cancer Center
Dallas, Texas 75246
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UT Southwestern Medical Center at Dallas
Dallas, Texas 75390
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Karmanos Cancer Institute
Detroit, Michigan 48201
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Tennessee Oncology, PLLC
Dickson, Tennessee 37055
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City of Hope
Duarte, California 91010
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Pharmaceutical Research Services
300 Research Drive
Durham, North Carolina 27710
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Durham, NC
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Duke Univ Med Ctr
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Weisberg Cancer Treatment Center
Farmington Hills, Michigan 48334
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Tennessee Oncology, PLLC
Franklin, Tennessee 37067
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Tennessee Oncology, PLLC
Gallatin, Tennessee 37066
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Virginia Oncology Associates
Hampton, Virginia 23666
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Tennessee Oncology, PLLC
Hermitage, Tennessee 37076
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Cancer Center Oncology Medical Group
La Mesa, California 91942
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Comprehensive Cancer Centers of Nevada
9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
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Nevada Cancer Institute, an affiliate of the UC San Diego Health System
3855 Health Sciences Drive
Las Vegas, Nevada 89135
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Tennessee Oncology, PLLC
Lebanon, Tennessee 37087
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Lac & Usc Medical Center
Los Angeles, California 90033
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U.S.C./Norris Comprehensive Cancer Center
1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
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Ronald Reagan UCLA Medical Center
Los Angeles, California 90095
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UCLA
Los Angeles, California 90095
(310) 825-4321
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University of Wisconsin Hospital and Clinics
600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
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c/o Prostate Oncology Specialist, Inc.
Marina Del Rey, California 90292
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UPMC Cancer Centers
1500 5th Avenue
McKeesport, Pennsylvania 15132
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Virginia Cancer Institute
Mechanicsville, Virginia
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Virginia Cancer Institute
Midlothian, Virginia
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Tennessee Oncology, PLLC
Murfreesboro, Tennessee 37130
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Grand Strand Urology
Myrtle Beach, South Carolina 29572
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Carolina Urologic Research Center
823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572
(843) 449-1010 ext.268
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Tennessee Oncology, PLLC
250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
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Sarah Cannon Research Institute
3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
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C/O: Thomas Ferencz R.Ph., BCOP
New Haven, Connecticut 06510
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Yale Univ School of Med
New Haven, Connecticut 06504
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Weill Cornell Medical College/New York Presbyterian Hospital
New York, New York 10021
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Memorial Sloan Kettering Cancer Center
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Virginia Oncology Associates
Newport News, Virginia 23606
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Virginia Oncology Associates
5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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North County Oncology Medical Clinic Inc
Oceanside, California 92056
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Palm Beach Cancer Institute
3401 PGA Boulevard
Palm Beach Gardens, Florida 33410
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Palm Beach Gardens, FL
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Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
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Mayo Clinic Hospital
Phoenix, Arizona
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UPMC Cancer Centers
Pittsburgh, Pennsylvania 15232
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VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania 15240
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University of Pittsburgh Cancer Institute
5150 Centre Ave
Pittsburgh, Pennsylvania 15232
(412) 647-2811
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Portland VA Medical Center
Portland, Oregon 97239
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Portland, OR
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Virginia Cancer Institute
Richmond, Virginia 23235
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The Mayo Clinic
Rochester, Minnesota 55905
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Barnes Jewish Hospital
Saint Louis, Missouri 63110
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Washington University School of Medicine
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
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Siteman Cancer Center
150 Entranceway Drive
Saint Peters, Missouri 63376
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Medical Oncology Associates - SD
San Diego, California 92123
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Sharp Memorial Hospital Investigational Pharmacy
San Diego, California 92123
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Sharp Rees-Stealy
San Diego, California 92123
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Premiere Oncology of Arizona
Scottsdale, Arizona 85260
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Mayo Clinic Arizona
13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
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University of Washington Medical Center
1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
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City of Hope Medical Group
South Pasadena, California 91030
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Stanford Hospital and Clinics Research Pharmacy
300 Pasteur Dr
Stanford, California 94305
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Stanford Univ Med Ctr
300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
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Virginia Oncology Associates
Virginia Beach, Virginia 23456
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George Washington University Medical Faculty Associates
Washington, District of Columbia 20037
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Palm Beach Cancer Institute
1395 State Road 7
Wellington, Florida 33414
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Palm Beach Cancer Institute, LLC
West Palm Beach, Florida 33401
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Virginia Oncology Associates
500 Sentara Circle
Williamsburg, Virginia 23188
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