Androgen Receptor PositivePhase 2NCT02749903
Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers
A Phase 2 study testing enzalutamide in people with Androgen Receptor Positive and Locally Advanced Salivary Gland Carcinoma, run by Alliance for Clinical Trials in Oncology at 287 sites in United States.
Trial summary
This phase II trial studies how well enzalutamide works in treating patients with androgen receptor positive salivary cancers that have spread from where it started to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (metastatic) and cannot be removed by surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Androgen Receptor Positive, Locally Advanced Salivary Gland Carcinoma, Metastatic Salivary Gland Carcinoma
- What is being tested?
- enzalutamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 287 sitesUnited States
- Study dates
- 14 Sep 2016to 5 Jul 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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.
- Disease status - Measurable disease as defined in the protocol. Locally advanced/unresectable (as determined by local surgeon) OR metastatic disease.
- 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).
- 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.
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- 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
- 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
- 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.
Trial locations and contacts
287 sites in 1 country.
287 sites in 1 country
United States287 sites
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
Community Hospital of Anaconda
Anaconda, Montana, 59711
Cancer Care Center at Island Hospital
Anacortes, Washington, 98221
Kaiser Permanente-Anaheim
Anaheim, California, 92806
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
Anchorage Oncology Centre
Anchorage, Alaska, 99508
Katmai Oncology Group
Anchorage, Alaska, 99508
Providence Alaska Medical Center
Anchorage, Alaska, 99508
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Inova Fairfax Hospital-Woodburn Infusion Clinic
Annandale, Virginia, 22003
University of Colorado Hospital
Aurora, Colorado, 80045
Rush - Copley Medical Center
Aurora, Illinois, 60504
Kaiser Permanente-Baldwin Park
Baldwin Park, California, 91706
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, 70809
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
Our Lady of the Lake Physicians Group - Medical Oncology
Baton Rouge, Louisiana, 70809
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, 15009
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
Swedish Cancer Institute-Eastside Oncology Hematology
Bellevue, Washington, 98005
Kaiser Permanente-Bellflower
Bellflower, California, 90706
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Saint Charles Health System
Bend, Oregon, 97701
Billings Clinic Cancer Center
Billings, Montana, 59101
Saint Vincent Healthcare
Billings, Montana, 59101
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Saint Joseph Medical Center
Bloomington, Illinois, 61701
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, 83712
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, 63628
Bozeman Deaconess Hospital
Bozeman, Montana, 59715
Henry Ford Cancer Institute?Downriver
Brownstown, Michigan, 48183
Roswell Park Cancer Institute
Buffalo, New York, 14263
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701
Illinois CancerCare-Canton
Canton, Illinois, 61520
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Southeast Cancer Center
Cape Girardeau, Missouri, 63703
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
SIH Cancer Institute
Carterville, Illinois, 62918
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459
Miami Valley Hospital South
Centerville, Ohio, 45459
Centralia Oncology Clinic
Centralia, Illinois, 62801
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
Medical University of South Carolina
Charleston, South Carolina, 29425
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729
Oncology Hematology Care Inc-Eden Park
Cincinnati, Ohio, 45202
Oncology Hematology Care Inc-Mercy West
Cincinnati, Ohio, 45211
Oncology Hematology Care Inc - Anderson
Cincinnati, Ohio, 45230
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
Oncology Hematology Care Inc-Blue Ash
Cincinnati, Ohio, 45242
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Providence Oncology and Hematology Care Southeast
Clackamas, Oregon, 97015
Greenville Health System Cancer Institute-Laurens
Clinton, South Carolina, 29325
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038
Big Horn Basin Cancer Center
Cody, Wyoming, 82414
Billings Clinic-Cody
Cody, Wyoming, 82414
Kootenai Medical Center
Coeur d'Alene, Idaho, 83814
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Memorial Sloan Kettering Commack
Commack, New York, 11725
Mercy Hospital
Coon Rapids, Minnesota, 55433
Bay Area Hospital
Coos Bay, Oregon, 97420
Northshore Oncology Associates-Covington
Covington, Louisiana, 70433
Oncology Hematology Care Inc-Crestview
Crestview Hills, Kentucky, 41017
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Carle on Vermilion
Danville, Illinois, 61832
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406
Miami Valley Hospital
Dayton, Ohio, 45409
Dayton Physicians LLC-Samaritan North
Dayton, Ohio, 45415
Miami Valley Hospital North
Dayton, Ohio, 45415
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, 48126
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Decatur Memorial Hospital
Decatur, Illinois, 62526
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309
Broadlawns Medical Center
Des Moines, Iowa, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, 50316
Henry Ford Hospital
Detroit, Michigan, 48202
Greenville Health System Cancer Institute-Easley
Easley, South Carolina, 29640
Memorial Sloan Kettering Westchester
East White Plains, New York, 10604
Marshfield Clinic Cancer Center - Eau Claire
Eau Claire, Wisconsin, 54701
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, 54701
Fairview-Southdale Hospital
Edina, Minnesota, 55435
Swedish Medical Center-Edmonds
Edmonds, Washington, 98026
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Crossroads Cancer Center
Effingham, Illinois, 62401
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Deaconess Clinic Downtown
Evansville, Indiana, 47713
Providence Regional Cancer Partnership
Everett, Washington, 98201
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824
Oncology Hematology Care Inc-Healthplex
Fairfield, Ohio, 45014
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Roger Maris Cancer Center
Fargo, North Dakota, 58122
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Armes Family Cancer Center
Findlay, Ohio, 45840
Blanchard Valley Hospital
Findlay, Ohio, 45840
Orion Cancer Care
Findlay, Ohio, 45840
Kaiser Permanente-Fontana
Fontana, California, 92335
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005
Unity Hospital
Fridley, Minnesota, 55432
Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland, Idaho, 83619
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405
Great Falls Clinic
Great Falls, Montana, 59405
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601
Dayton Physicians LLC-Wayne
Greenville, Ohio, 45331
Wayne Hospital
Greenville, Ohio, 45331
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina, 29605
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, 29605
Greenville Memorial Hospital
Greenville, South Carolina, 29605
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, 29615
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, 29650
Saint Peter's Community Hospital
Helena, Montana, 59601
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Oncology Center of The South Incorporated
Houma, Louisiana, 70360
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Kaiser Permanente-Irvine
Irvine, California, 92618
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
Allegiance Health
Jackson, Michigan, 49201
Capital Region Southwest Campus
Jefferson City, Missouri, 65109
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, 15901
Kalispell Regional Medical Center
Kalispell, Montana, 59901
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
Greater Dayton Cancer Center
Kettering, Ohio, 45409
First Dayton Cancer Care
Kettering, Ohio, 45420
Kettering Medical Center
Kettering, Ohio, 45429
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Providence Regional Cancer System-Lacey
Lacey, Washington, 98503
Marshfield Clinic - Ladysmith Center
Ladysmith, Wisconsin, 54848
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, 73505
Beebe Medical Center
Lewes, Delaware, 19958
PeaceHealth Saint John Medical Center
Longview, Washington, 98632
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Kaiser Permanente-Cadillac
Los Angeles, California, 90034
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Fairview Maple Grove Medical Center
Maple Grove, Minnesota, 55369
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
Marshfield Clinic
Marshfield, Wisconsin, 54449
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, 15132
Saint Luke's Mountain States Tumor Institute - Meridian
Meridian, Idaho, 83642
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, 46360
Woodland Cancer Care Center
Michigan City, Indiana, 46360
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Dayton Physicians LLC-Signal Point
Middletown, Ohio, 45042
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Health Partners Inc
Minneapolis, Minnesota, 55454
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802
Community Medical Hospital
Missoula, Montana, 59804
UPMC-Coraopolis/Heritage Valley Radiation Oncology
Moon Township, Pennsylvania, 15108
Morristown Medical Center
Morristown, New Jersey, 07960
Saint Luke's Mountain States Tumor Institute - Nampa
Nampa, Idaho, 83686
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, 06510
Yale University
New Haven, Connecticut, 06520
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017
New Ulm Medical Center
New Ulm, Minnesota, 56073
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, 19713
Helen F Graham Cancer Center
Newark, Delaware, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Regional Hematology and Oncology PA
Newark, Delaware, 19713
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
Providence Newberg Medical Center
Newberg, Oregon, 97132
Chancellor Center for Oncology
Newburgh, Indiana, 47630
Henry Ford Medical Center-Columbus
Novi, Michigan, 48377
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Kaiser Permanente-Ontario
Ontario, California, 91761
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Radiation Oncology of Northern Illinois
Ottawa, Illinois, 61350
Kaiser Permanente - Panorama City
Panorama City, California, 91402
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, 61554
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
Illinois CancerCare-Peru
Peru, Illinois, 61354
Valley Radiation Oncology
Peru, Illinois, 61354
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
UPMC-Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, 15215
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, 15237
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, 15243
Providence Portland Medical Center
Portland, Oregon, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Kootenai Cancer Center
Post Falls, Idaho, 83854
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
Saint Charles Health System-Redmond
Redmond, Oregon, 97756
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, 54868
Reid Health
Richmond, Indiana, 47374
Kaiser Permanente-Riverside
Riverside, California, 92505
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422
Mayo Clinic
Rochester, Minnesota, 55905
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, 11570
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Regions Hospital
Saint Paul, Minnesota, 55101
United Hospital
Saint Paul, Minnesota, 55102
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
Kaiser Permanente-San Diego Mission
San Diego, California, 92108
Kaiser Permanente-San Diego Zion
San Diego, California, 92120
Kaiser Permanente-San Marcos
San Marcos, California, 92078
Kootenai Cancer Clinic
Sandpoint, Idaho, 83864
Nanticoke Memorial Hospital
Seaford, Delaware, 19973
Minor and James Medical PLLC
Seattle, Washington, 98104
Pacific Gynecology Specialists
Seattle, Washington, 98104
Swedish Medical Center-Ballard Campus
Seattle, Washington, 98107
Kaiser Permanente Washington
Seattle, Washington, 98112
Swedish Medical Center-First Hill
Seattle, Washington, 98122-4307
Swedish Medical Center-Cherry Hill
Seattle, Washington, 98122-5711
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, 98284
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, 16346
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, 29672
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379
Providence Regional Cancer System-Shelton
Shelton, Washington, 98584
Welch Cancer Center
Sheridan, Wyoming, 82801
Dayton Physicians LLC-Wilson
Sidney, Ohio, 45365
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, 29307
Rockwood Cancer Treatment Center-DHEC-Downtown
Spokane, Washington, 99204
Rockwood North Cancer Treatment Center
Spokane, Washington, 99218
Rockwood Clinic Cancer Treatment Center-Valley
Spokane Valley, Washington, 99216
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62702
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Springfield Clinic
Springfield, Illinois, 62702
Memorial Medical Center
Springfield, Illinois, 62781
Springfield Regional Cancer Center
Springfield, Ohio, 45504
Springfield Regional Medical Center
Springfield, Ohio, 45505
Washington University School of Medicine
St Louis, Missouri, 63110
Siteman Cancer Center-South County
St Louis, Missouri, 63129
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin, 54482
Lakeview Hospital
Stillwater, Minnesota, 55082
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
Overlook Hospital
Summit, New Jersey, 07902
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri, 63127
Cancer Care Specialists of Illinois-Swansea
Swansea, Illinois, 62226
Southwest Illinois Health Services LLP
Swansea, Illinois, 62226
Dayton Physicians LLC-Upper Valley
Troy, Ohio, 45373
Upper Valley Medical Center
Troy, Ohio, 45373
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611
Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls, Idaho, 83301
UPMC Uniontown Hospital Radiation Oncology
Uniontown, Pennsylvania, 15401
Carle Cancer Center
Urbana, Illinois, 61801
The Carle Foundation Hospital
Urbana, Illinois, 61801
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664
Ridgeview Medical Center
Waconia, Minnesota, 55387
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, 99362
UPMC Washington Hospital Radiation Oncology
Washington, Pennsylvania, 15301
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, 54401
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
Methodist West Hospital
West Des Moines, Iowa, 50266-7700
Marshfield Clinic - Weston Center
Weston, Wisconsin, 54476
UPMC Susquehanna
Williamsport, Pennsylvania, 17701
Rice Memorial Hospital
Willmar, Minnesota, 56201
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, 19801
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125
Kaiser Permanente-Woodland Hills
Woodland Hills, California, 91367
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, 98902
Providence Regional Cancer System-Yelm
Yelm, Washington, 98597
Rush-Copley Healthcare Center
Yorkville, Illinois, 60560
About this study
Official title: A Phase II Study of Enzalutamide (NSC# 766085) for Patients With Androgen Receptor Positive Salivary Cancers
This phase II trial studies how well enzalutamide works in treating patients with androgen receptor positive salivary cancers that have spread from where it started to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (metastatic) and cannot be removed by surgery. Proteins called androgen receptors bind to androgens (hormones) and may cause tumor cells to grow. Enzalutamide may stop the growth of tumor cells by binding to and blocking androgen receptor proteins.
Read the 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
- To evaluate the progression-free survival (PFS) of AR-positive salivary cancer patients treated with enzalutamide
- To evaluate the overall survival (OS) of AR-positive salivary cancer patients treated with enzalutamide
- To evaluate the safety/tolerability of enzalutamide for patients with AR-positive salivary cancer
Patients are followed up to 3 years after study enrollment.
- Conditions
- Androgen Receptor Positive, Locally Advanced Salivary Gland Carcinoma, Metastatic Salivary Gland Carcinoma, Salivary Duct Carcinoma, Salivary Gland Adenocarcinoma, NOS, Salivary Gland Basal Cell Adenocarcinoma
- Being tested
- enzalutamide
- Medical subject headings
- Salivary Gland Neoplasms, Pyloric Stenosis, Hypertrophic, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enzalutamideDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| Enzalutamide | Other | 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. Receives: Drug: enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Overall Response Rate
The best overall response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.
Measured: Up to 32 weeks
Secondary outcomes (2)
Progression-free Survival
Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: Up to 32 months post study enrollment
Number of Patients Experiencing at Least One Grade 3+ Adverse Event Using CTCAE Version 4.0
The number of patients experiencing at least one grade 3+ adverse event using CTCAE version 4.0 is summarized below.
Measured: 30 days post-treatment, up to 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study start14 Sep 2016
- Primary completion21 Feb 2019
- Study completion5 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Androgen Receptor PositiveStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Astellas Pharma US, Inc.
- Responsible party
- Sponsor
- Investigators
- Alan Ho, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749903
- Sponsor's protocol ID
- A091404
- Other IDs
- NCI-2015-01706
- Status last verified
- Jan 2026
- First submitted
- 21 Apr 2016
- Last updated
- 7 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ho AL, Foster NR, Zoroufy AJ, Campbell JD, Worden F, Price K, Adkins D, Bowles DW, Kang H, Burtness B, Sherman E, Morton R, Morris LGT, Nadeem Z, Katabi N, Munster P, Schwartz GK. Phase II Study of Enzalutamide for Patients With Androgen Receptor-Positive Salivary Gland Cancers (Alliance A091404). J Clin Oncol. 2022 Dec 20;40(36):4240-4249. doi: 10.1200/JCO.22.00229. Epub 2022 Jul 22.
PubMed 35867947