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Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02749903
Recruitment Status : Active, not recruiting
First Posted : April 25, 2016
Last Update Posted : May 29, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:
This study will test any good and bad effects of the study drug called enzalutamide. Enzalutamide could shrink the cancer but it could also cause side effects. Researchers hope to learn if the study drug will shrink the cancer by at least 30% compared to its present size, in at least 1 out of 5 patients. Enzalutamide is not FDA approved to treat salivary gland cancer, but it has already been FDA-approved to treat other cancers.

Condition or disease Intervention/treatment Phase
Salivary Cancer Drug: enzalutamide Phase 2

Detailed Description:

This single arm Phase II trial will assess the best overall response associated with enzalutamide in patients with AR-positive salivary cancers. Given that this will be one of the first prospective studies ever conducted for AR-positive salivary cancers, and there are currently no standard therapies known to be effective for this disease, the investigators will adopt a best overall response (BOR) of 5% as the null hypothesis and BOR of 20 % as the alternative hypothesis. In addition to response, this study will also evaluate the progression-free survival (PFS), overall survival (OS), adverse events, and will also try to identify molecular predictors of response by examining genomic and transcriptional elements of androgen receptor biology.

The primary and secondary objectives of the study:

Primary objective

To evaluate the rate of best overall response associated with enzalutamide in patients with AR-positive salivary cancers

Secondary objectives

  1. To evaluate the progression-free survival (PFS) of AR-positive salivary cancer patients treated with enzalutamide
  2. To evaluate the overall survival (OS) of AR-positive salivary cancer patients treated with enzalutamide
  3. To evaluate the safety/tolerability of enzalutamide for patients with AR-positive salivary cancer

Patients are followed up to 3 years after study enrollment.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Enzalutamide (NSC# 766085) for Patients With Androgen Receptor Positive Salivary Cancers
Study Start Date : June 2016
Actual Primary Completion Date : February 21, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Enzalutamide
Patients receive 160 mg enzalutamide orally once daily (1 cycle=28 days). Patients will remain on therapy until progression of disease or development of unacceptable toxicities or patient or physician withdrawal. Patients will undergo radiographic imaging every 2 months while on study treatment in order to determine response.
Drug: enzalutamide
oral




Primary Outcome Measures :
  1. best overall response rate [ Time Frame: Up to 32 weeks ]

Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: Up to 3 years post study enrollment ]
  2. adverse events (The maximum grade for each type of adverse event will be summarized using CTCAE version 4.0.) [ Time Frame: Up to 3 years post study enrollment ]
  3. adverse events (The frequency and percentage of grade 3+ adverse events will be summarized using CTCAE version 4.0.) [ Time Frame: Up to 3 years post study enrollment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. Documentation of Disease - Histologic Documentation: Histologically proven diagnosis of salivary cancer by central pathology review. Receptor status: AR expression detected by immunohistochemistry by central review.
  2. Disease status - Measurable disease as defined in the protocol. Locally advanced/unresectable (as determined by local surgeon) OR metastatic disease.
  3. Prior Treatment

    • Any number of prior lines of therapy
    • No treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation ≤ 28 days before study registration. No treatment with nitrosourea or mitomycin ≤ 42 days before study registration
    • No prior therapy with enzalutamide (previous chemotherapy and/or other AR-targeted approaches is allowed).
  4. Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. A female of childbearing potent is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (ie, has had menses at any time in the preceding 12 consecutive months). For women of childbearing potential only, a negative pregnancy test done ≤ 5 days prior to registration is required.
  5. Age ≥ 18 years
  6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
  7. No History of the following:

    • prior brain metastases
    • leptomeningeal disease
    • seizures
    • class 3 or 4 congestive heart failure
    • uncontrolled hypertension (systolic BP > 170 mmHg or diastolic BP > 105 mmHg)
    • major surgery ≤ 4 weeks of registration
  8. Required Initial Laboratory Values:

    • Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
    • Platelet Count ≥ 100,000/mm3
    • Creatinine ≤ 1.5 x ULN Upper Limit of Normal (ULN) OR
    • Calculated Creatinine Clearance ≥ 30 mL/min
    • Total Bilirubin ≤ 1.5 x ULN
    • AST/ALT ≤ 3.0 x ULN
  9. Concomitant medications- Chronic concomitant treatment with strong CYP2C8 inhibitors is not allowed. Patients must discontinue the drug ≥ 14 days prior to registration. Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug ≥ 14 days prior to registration.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02749903


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Locations
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United States, Alaska
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States, 98508
Anchorage Radiation Therapy Center
Anchorage, Alaska, United States, 99504
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States, 99508
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States, 99508
Alaska Women's Cancer Care
Anchorage, Alaska, United States, 99508
Anchorage Oncology Centre
Anchorage, Alaska, United States, 99508
Katmai Oncology Group
Anchorage, Alaska, United States, 99508
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
United States, California
Kaiser Permanente-Anaheim
Anaheim, California, United States, 92806
Kaiser Permanente-Baldwin Park
Baldwin Park, California, United States, 91706
Kaiser Permanente-Bellflower
Bellflower, California, United States, 90706
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States, 91505
Kaiser Permanente-Fontana
Fontana, California, United States, 92335
Kaiser Permanente-Irvine
Irvine, California, United States, 92618
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
Kaiser Permanente-Cadillac
Los Angeles, California, United States, 90034
Kaiser Permanente-Ontario
Ontario, California, United States, 91761
Kaiser Permanente - Panorama City
Panorama City, California, United States, 91402
Kaiser Permanente-Riverside
Riverside, California, United States, 92505
Kaiser Permanente-San Diego Mission
San Diego, California, United States, 92108
Kaiser Permanente-San Diego Zion
San Diego, California, United States, 92120
Kaiser Permanente-San Marcos
San Marcos, California, United States, 92078
Kaiser Permanente-Woodland Hills
Woodland Hills, California, United States, 91367
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
United States, Connecticut
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, United States, 06824
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, United States, 06510
Yale University
New Haven, Connecticut, United States, 06520
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States, 06611
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, United States, 19713
Helen F Graham Cancer Center
Newark, Delaware, United States, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States, 19713
Regional Hematology and Oncology PA
Newark, Delaware, United States, 19713
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
Beebe Health Campus
Rehoboth Beach, Delaware, United States, 19971
Nanticoke Memorial Hospital
Seaford, Delaware, United States, 19973
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States, 19801
United States, Idaho
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, United States, 83712
Kootenai Medical Center
Coeur d'Alene, Idaho, United States, 83814
Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland, Idaho, United States, 83619
Saint Luke's Mountain States Tumor Institute - Meridian
Meridian, Idaho, United States, 83642
Saint Luke's Mountain States Tumor Institute - Nampa
Nampa, Idaho, United States, 83686
Kootenai Cancer Center
Post Falls, Idaho, United States, 83854
Kootenai Cancer Clinic
Sandpoint, Idaho, United States, 83864
Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls, Idaho, United States, 83301
United States, Illinois
Rush - Copley Medical Center
Aurora, Illinois, United States, 60504
Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States, 61704
Illinois CancerCare-Canton
Canton, Illinois, United States, 61520
Memorial Hospital of Carbondale
Carbondale, Illinois, United States, 62902
SIH Cancer Institute
Carterville, Illinois, United States, 62918
Illinois CancerCare-Carthage
Carthage, Illinois, United States, 62321
Centralia Oncology Clinic
Centralia, Illinois, United States, 62801
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States, 60612
Carle on Vermilion
Danville, Illinois, United States, 61832
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States, 62526
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Crossroads Cancer Center
Effingham, Illinois, United States, 62401
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States, 61401
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States, 61401
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States, 61443
Illinois CancerCare-Macomb
Macomb, Illinois, United States, 61455
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Radiation Oncology of Northern Illinois
Ottawa, Illinois, United States, 61350
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61554
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, United States, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Illinois CancerCare-Peru
Peru, Illinois, United States, 61354
Valley Radiation Oncology
Peru, Illinois, United States, 61354
Illinois CancerCare-Princeton
Princeton, Illinois, United States, 61356
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62702
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Springfield Clinic
Springfield, Illinois, United States, 62702
Memorial Medical Center
Springfield, Illinois, United States, 62781
Cancer Care Specialists of Illinois-Swansea
Swansea, Illinois, United States, 62226
Southwest Illinois Health Services LLP
Swansea, Illinois, United States, 62226
Carle Cancer Center
Urbana, Illinois, United States, 61801
The Carle Foundation Hospital
Urbana, Illinois, United States, 61801
Rush-Copley Healthcare Center
Yorkville, Illinois, United States, 60560
United States, Indiana
Deaconess Clinic Downtown
Evansville, Indiana, United States, 47713
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, United States, 46360
Woodland Cancer Care Center
Michigan City, Indiana, United States, 46360
Chancellor Center for Oncology
Newburgh, Indiana, United States, 47630
Reid Health
Richmond, Indiana, United States, 47374
United States, Iowa
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Broadlawns Medical Center
Des Moines, Iowa, United States, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Methodist West Hospital
West Des Moines, Iowa, United States, 50266-7700
United States, Kentucky
Oncology Hematology Care Inc-Crestview
Crestview Hills, Kentucky, United States, 41017
United States, Louisiana
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, United States, 70805
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, United States, 70809
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
Our Lady of the Lake Physicians Group - Medical Oncology
Baton Rouge, Louisiana, United States, 70809
Northshore Oncology Associates-Covington
Covington, Louisiana, United States, 70433
Oncology Center of The South Incorporated
Houma, Louisiana, United States, 70360
United States, Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Henry Ford Cancer Institute?Downriver
Brownstown, Michigan, United States, 48183
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, United States, 48038
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, United States, 48126
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Allegiance Health
Jackson, Michigan, United States, 49201
Henry Ford Medical Center-Columbus
Novi, Michigan, United States, 48377
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States, 48322
United States, Minnesota
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States, 56601
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Unity Hospital
Fridley, Minnesota, United States, 55432
Fairview Maple Grove Medical Center
Maple Grove, Minnesota, United States, 55369
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Health Partners Inc
Minneapolis, Minnesota, United States, 55454
New Ulm Medical Center
New Ulm, Minnesota, United States, 56073
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Mayo Clinic
Rochester, Minnesota, United States, 55905
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
Fairview Lakes Medical Center
Wyoming, Minnesota, United States, 55092
United States, Missouri
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, United States, 63628
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
Southeast Cancer Center
Cape Girardeau, Missouri, United States, 63703
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Capital Region Southwest Campus
Jefferson City, Missouri, United States, 65109
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Siteman Cancer Center-South County
Saint Louis, Missouri, United States, 63129
Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri, United States, 63376
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States, 63670
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States, 63080
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri, United States, 63127
United States, Montana
Community Hospital of Anaconda
Anaconda, Montana, United States, 59711
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Great Falls Clinic
Great Falls, Montana, United States, 59405
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
Community Medical Hospital
Missoula, Montana, United States, 59804
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
United States, New Jersey
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Overlook Hospital
Summit, New Jersey, United States, 07902
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Northwell Health/Center for Advanced Medicine
Lake Success, New York, United States, 11042
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, United States, 11570
United States, North Dakota
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
United States, Ohio
Indu and Raj Soin Medical Center
Beavercreek, Ohio, United States, 45431
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, United States, 45459
Miami Valley Hospital South
Centerville, Ohio, United States, 45459
Oncology Hematology Care Inc-Eden Park
Cincinnati, Ohio, United States, 45202
Oncology Hematology Care Inc-Mercy West
Cincinnati, Ohio, United States, 45211
Oncology Hematology Care Inc - Anderson
Cincinnati, Ohio, United States, 45230
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, United States, 45236
Oncology Hematology Care Inc-Blue Ash
Cincinnati, Ohio, United States, 45242
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States, 45406
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Dayton Physicians LLC-Samaritan North
Dayton, Ohio, United States, 45415
Miami Valley Hospital North
Dayton, Ohio, United States, 45415
Oncology Hematology Care Inc-Healthplex
Fairfield, Ohio, United States, 45014
Armes Family Cancer Center
Findlay, Ohio, United States, 45840
Blanchard Valley Hospital
Findlay, Ohio, United States, 45840
Orion Cancer Care
Findlay, Ohio, United States, 45840
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Dayton Physicians LLC-Atrium
Franklin, Ohio, United States, 45005
Dayton Physicians LLC-Wayne
Greenville, Ohio, United States, 45331
Wayne Hospital
Greenville, Ohio, United States, 45331
Greater Dayton Cancer Center
Kettering, Ohio, United States, 45409
First Dayton Cancer Care
Kettering, Ohio, United States, 45420
Kettering Medical Center
Kettering, Ohio, United States, 45429
Dayton Physicians LLC-Signal Point
Middletown, Ohio, United States, 45042
Dayton Physicians LLC-Wilson
Sidney, Ohio, United States, 45365
Springfield Regional Cancer Center
Springfield, Ohio, United States, 45504
Springfield Regional Medical Center
Springfield, Ohio, United States, 45505
Dayton Physicians LLC-Upper Valley
Troy, Ohio, United States, 45373
Upper Valley Medical Center
Troy, Ohio, United States, 45373
United States, Oklahoma
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, United States, 73505
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Saint Charles Health System
Bend, Oregon, United States, 97701
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Providence Oncology and Hematology Care Southeast
Clackamas, Oregon, United States, 97015
Bay Area Hospital
Coos Bay, Oregon, United States, 97420
Providence Newberg Medical Center
Newberg, Oregon, United States, 97132
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States, 97045
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Saint Charles Health System-Redmond
Redmond, Oregon, United States, 97756
United States, Pennsylvania
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, United States, 15009
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, United States, 19317
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States, 15601
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, United States, 15901
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, United States, 15132
UPMC-Coraopolis/Heritage Valley Radiation Oncology
Moon, Pennsylvania, United States, 15108
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
UPMC-Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, United States, 15215
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, United States, 15232
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, United States, 15237
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, United States, 15243
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, United States, 16346
UPMC Uniontown Hospital Radiation Oncology
Uniontown, Pennsylvania, United States, 15401
UPMC Washington Hospital Radiation Oncology
Washington, Pennsylvania, United States, 15301
UPMC Susquehanna
Williamsport, Pennsylvania, United States, 17701
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Greenville Health System Cancer Institute-Laurens
Clinton, South Carolina, United States, 29325
Greenville Health System Cancer Institute-Easley
Easley, South Carolina, United States, 29640
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States, 29605
Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States, 29615
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, United States, 29650
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States, 29672
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States, 29307
United States, South Dakota
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
United States, Virginia
Inova Fairfax Hospital-Woodburn Infusion Clinic
Annandale, Virginia, United States, 22003
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
United States, Washington
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, United States, 98520
Cancer Care Center at Island Hospital
Anacortes, Washington, United States, 98221
Swedish Cancer Institute-Eastside Oncology Hematology
Bellevue, Washington, United States, 98005
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States, 98225
Providence Regional Cancer System-Centralia
Centralia, Washington, United States, 98531
Swedish Medical Center-Edmonds
Edmonds, Washington, United States, 98026
Providence Regional Cancer Partnership
Everett, Washington, United States, 98201
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States, 98029
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States, 99336
Providence Regional Cancer System-Lacey
Lacey, Washington, United States, 98503
PeaceHealth Saint John Medical Center
Longview, Washington, United States, 98632
Minor and James Medical PLLC
Seattle, Washington, United States, 98104
Pacific Gynecology Specialists
Seattle, Washington, United States, 98104
Swedish Medical Center-Ballard Campus
Seattle, Washington, United States, 98107
Kaiser Permanente Washington
Seattle, Washington, United States, 98112
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
Swedish Medical Center-Cherry Hill
Seattle, Washington, United States, 98122-5711
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, United States, 98284
Providence Regional Cancer System-Shelton
Shelton, Washington, United States, 98584
Rockwood Clinic Cancer Treatment Center-Valley
Spokane Valley, Washington, United States, 99216
Rockwood Cancer Treatment Center-DHEC-Downtown
Spokane, Washington, United States, 99204
Rockwood North Cancer Treatment Center
Spokane, Washington, United States, 99218
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States, 98664
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, United States, 99362
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
Providence Regional Cancer System-Yelm
Yelm, Washington, United States, 98597
United States, Wisconsin
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, United States, 54729
Marshfield Clinic Cancer Center - Eau Claire
Eau Claire, Wisconsin, United States, 54701
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States, 54701
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Marshfield Clinic - Ladysmith Center
Ladysmith, Wisconsin, United States, 54848
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States, 54548
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States, 54017
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States, 54868
Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin, United States, 54482
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, United States, 54401
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States, 54494
United States, Wyoming
Big Horn Basin Cancer Center
Cody, Wyoming, United States, 82414
Billings Clinic-Cody
Cody, Wyoming, United States, 82414
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Astellas Pharma US, Inc.
Investigators
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Study Chair: Alan Ho, MD Memorial Sloan Kettering Cancer Center

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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT02749903     History of Changes
Other Study ID Numbers: A091404
NCI-2015-01706 ( Registry Identifier: NCI Clinical Trial Reporting Program )
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs