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
We found this trial at
92
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Murfreesboro, Tennessee 37130
2001
mi
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Murfreesboro, TN
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Baltimore, Maryland 21231
410-955-6190
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
2329
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Baltimore, MD
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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...
2072
mi
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Birmingham, AL
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
2485
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Boston, MA
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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...
2110
mi
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Buffalo, NY
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
1737
mi
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Chicago, IL
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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...
1971
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Nashville, TN
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
2371
mi
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Philadelphia, PA
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1600 Divisadero Street
San Francisco, California 94115
888.689.8273
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
680
mi
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San Francisco, CA
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
0
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Seattle, WA
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Albuquerque, New Mexico 87109
1183
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Albuquerque, NM
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2178
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Atlanta, GA
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5507 South Congress Avenue
Atlantis, Florida 33462
2696
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Atlantis, FL
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Aurora, Colorado 80045
1026
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Aurora, CO
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13001 East 17th Place
Aurora, Colorado 80045
1026
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Aurora, CO
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
2329
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Baltimore, MD
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9090 Wilshire Boulevard
Beverly Hills, California 90211
959
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Beverly Hills, CA
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Beverly Hills, California
958
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Beverly Hills, CA
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Boston, Massachusetts 02114
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Boston, MA
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Boston, Massachusetts 02115
2485
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Boston, MA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
2485
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Boston, MA
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6918
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Buenos Aires,
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Charleston, South Carolina 29425
2422
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Charleston, SC
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Charleston, South Carolina 29425
2422
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Charleston, SC
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Chattanooga, Tennessee 37404
2085
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Chattanooga, TN
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Chesapeake, Virginia 23320
2437
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Chesapeake, VA
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
1737
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Chicago, IL
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Creve Coeur, Missouri 63141
1708
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Creve Coeur, MO
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1676
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Dallas, TX
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Dallas, TX
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Dallas, TX
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Detroit, Michigan 48201
1932
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Detroit, MI
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Dickson, Tennessee 37055
1946
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Dickson, TN
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Duarte, California 91010
959
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Duarte, CA
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300 Research Drive
Durham, North Carolina 27710
2339
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Durham, NC
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
2341
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Durham, NC
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Farmington Hills, Michigan 48334
1914
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Farmington Hills, MI
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Franklin, Tennessee 37067
1981
mi
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Franklin, TN
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Gallatin, Tennessee 37066
1977
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Gallatin, TN
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Hampton, Virginia 23666
2418
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Hampton, VA
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Hermitage, Tennessee 37076
1980
mi
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Hermitage, TN
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La Mesa, California 91942
1064
mi
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La Mesa, CA
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
878
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Las Vegas, NV
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3855 Health Sciences Drive
Las Vegas, Nevada 89135
1053
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Las Vegas, NV
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Lebanon, Tennessee 37087
1991
mi
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Lebanon, TN
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Los Angeles, California 90033
962
mi
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Los Angeles, CA
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
962
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Los Angeles, CA
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Los Angeles, California 90095
979
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Los Angeles, CA
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Los Angeles, California 90095
(310) 825-4321
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
979
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Los Angeles, CA
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
1616
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Madison, WI
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Marina Del Rey, California 90292
964
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Marina Del Rey, CA
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1500 5th Avenue
McKeesport, Pennsylvania 15132
2142
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McKeesport, PA
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Mechanicsville, Virginia
2352
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Mechanicsville, VA
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Midlothian, Virginia
2343
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Midlothian, VA
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Myrtle Beach, South Carolina 29572
2434
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Myrtle Beach, SC
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823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572
(843) 449-1010 ext.268
Carolina Urologic Research Center Carolina Urologic Research Center (CURC) has been recognized both nationally and...
2435
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Myrtle Beach, SC
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
1908
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Nashville, TN
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
1971
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Nashville, TN
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New Haven, Connecticut 06510
2432
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New Haven, CT
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New Haven, Connecticut 06504
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New Haven, CT
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2402
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New York, NY
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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...
2402
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New York, NY
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Newport News, Virginia 23606
2412
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Newport News, VA
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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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Oceanside, California 92056
1031
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3401 PGA Boulevard
Palm Beach Gardens, Florida 33410
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Philadelphia, Pennsylvania 19111
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Phoenix, Arizona
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Pittsburgh, Pennsylvania 15232
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Pittsburgh, Pennsylvania 15240
2131
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5150 Centre Ave
Pittsburgh, Pennsylvania 15232
(412) 647-2811
University of Pittsburgh Cancer Institute Founded in 1985, the University of Pittsburgh Cancer Institute (UPCI)...
2135
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Portland, Oregon 97239
149
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Portland, OR
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Richmond, Virginia 23235
2346
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Richmond, VA
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Rochester, Minnesota 55905
1450
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Rochester, MN
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Saint Louis, Missouri 63110
1717
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Saint Louis, MO
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
1718
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Saint Louis, MO
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150 Entranceway Drive
Saint Peters, Missouri 63376
1697
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Saint Peters, MO
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San Diego, California 92123
1065
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San Diego, CA
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1059
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San Diego, California 92123
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Scottsdale, Arizona 85260
1111
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Scottsdale, AZ
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
1113
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
2
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Seattle, WA
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Smyrna, Tennessee 37167
1990
mi
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Smyrna, TN
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South Pasadena, California 91030
958
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South Pasadena, CA
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300 Pasteur Dr
Stanford, California 94305
704
mi
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Stanford, CA
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
704
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Stanford, CA
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Virginia Beach, Virginia 23456
2447
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Virginia Beach, VA
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Washington, District of Columbia 20037
2322
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Washington,
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1395 State Road 7
Wellington, Florida 33414
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Wellington, FL
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West Palm Beach, Florida 33401
2692
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West Palm Beach, FL
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500 Sentara Circle
Williamsburg, Virginia 23188
2391
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Williamsburg, VA
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