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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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
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92
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New Haven, Connecticut 06510
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Baltimore, Maryland 21231
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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330 Brookline Ave
Boston, Massachusetts 02215
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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666 Elm Street
Buffalo, New York 14263
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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5801 South Ellis Avenue
Chicago, Illinois 60637
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University of Chicago One of the world's premier academic and research institutions, the University of...
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1211 Medical Center Dr
Nashville, Tennessee 37232
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Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
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1600 Divisadero Street
San Francisco, California 94115
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UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
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825 Eastlake Ave E
Seattle, Washington 98109
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Albuquerque, New Mexico 87109
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5507 South Congress Avenue
Atlantis, Florida 33462
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Aurora, Colorado 80045
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13001 East 17th Place
Aurora, Colorado 80045
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1800 Orleans St.
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9090 Wilshire Boulevard
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Boston, Massachusetts 02114
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Boston, Massachusetts 02115
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450 Brookline Ave
Boston, Massachusetts 2215
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Charleston, South Carolina 29425
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Charleston, South Carolina 29425
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Chattanooga, Tennessee 37404
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Chesapeake, Virginia 23320
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5841 S Maryland Ave
Chicago, Illinois 60637
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Creve Coeur, Missouri 63141
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Detroit, Michigan 48201
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Dickson, Tennessee 37055
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Duarte, California 91010
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300 Research Drive
Durham, North Carolina 27710
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2301 Erwin Rd
Durham, North Carolina 27710
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Farmington Hills, Michigan 48334
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Franklin, Tennessee 37067
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Gallatin, Tennessee 37066
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Hampton, Virginia 23666
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Hermitage, Tennessee 37076
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La Mesa, California 91942
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
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3855 Health Sciences Drive
Las Vegas, Nevada 89135
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Lebanon, Tennessee 37087
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Los Angeles, California 90033
11
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1441 Eastlake Ave
Los Angeles, California 90033
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Los Angeles, California 90095
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Los Angeles, California 90095
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600 Highland Ave
Madison, Wisconsin 53792
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Marina Del Rey, California 90292
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1500 5th Avenue
McKeesport, Pennsylvania 15132
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Mechanicsville, Virginia
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Midlothian, Virginia
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Murfreesboro, Tennessee 37130
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Myrtle Beach, South Carolina 29572
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823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572
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Carolina Urologic Research Center Carolina Urologic Research Center (CURC) has been recognized both nationally and...
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
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3322 West End Avenue
Nashville, Tennessee 37203
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New Haven, Connecticut 06504
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5900 Lake Wright Dr
Norfolk, Virginia 23502
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Palm Beach Gardens, Florida 33410
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Pittsburgh, Pennsylvania 15240
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5150 Centre Ave
Pittsburgh, Pennsylvania 15232
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Portland, Oregon 97239
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Richmond, Virginia 23235
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Rochester, Minnesota 55905
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Saint Louis, Missouri 63110
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660 S Euclid Ave
Saint Louis, Missouri 63110
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Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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150 Entranceway Drive
Saint Peters, Missouri 63376
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Scottsdale, Arizona 85260
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
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1959 NE Pacific St
Seattle, Washington 98195
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Smyrna, Tennessee 37167
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South Pasadena, California 91030
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300 Pasteur Dr
Stanford, California 94305
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300 Pasteur Dr
Stanford, California 94305
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Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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Virginia Beach, Virginia 23456
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Washington, District of Columbia 20037
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1395 State Road 7
Wellington, Florida 33414
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West Palm Beach, Florida 33401
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500 Sentara Circle
Williamsburg, Virginia 23188
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