Spots Global Cancer Trial Database for Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers
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Trial Identification
Brief Title: Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers
Official Title: A Phase II Study of Enzalutamide (NSC# 766085) for Patients With Androgen Receptor Positive Salivary Cancers
Study ID: NCT02749903
Conditions
Interventions
Study Description
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.
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States
Anchorage Radiation Therapy Center, Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC, Anchorage, Alaska, United States
Alaska Women's Cancer Care, Anchorage, Alaska, United States
Anchorage Oncology Centre, Anchorage, Alaska, United States
Katmai Oncology Group, Anchorage, Alaska, United States
Providence Alaska Medical Center, Anchorage, Alaska, United States
Kaiser Permanente-Anaheim, Anaheim, California, United States
Kaiser Permanente-Baldwin Park, Baldwin Park, California, United States
Kaiser Permanente-Bellflower, Bellflower, California, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, California, United States
Kaiser Permanente-Fontana, Fontana, California, United States
Kaiser Permanente-Irvine, Irvine, California, United States
Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States
Kaiser Permanente-Cadillac, Los Angeles, California, United States
Kaiser Permanente-Ontario, Ontario, California, United States
Kaiser Permanente - Panorama City, Panorama City, California, United States
Kaiser Permanente-Riverside, Riverside, California, United States
Kaiser Permanente-San Diego Mission, San Diego, California, United States
Kaiser Permanente-San Diego Zion, San Diego, California, United States
Kaiser Permanente-San Marcos, San Marcos, California, United States
Kaiser Permanente-Woodland Hills, Woodland Hills, California, United States
University of Colorado Hospital, Aurora, Colorado, United States
Smilow Cancer Hospital Care Center-Fairfield, Fairfield, Connecticut, United States
Smilow Cancer Center/Yale-New Haven Hospital, New Haven, Connecticut, United States
Yale University, New Haven, Connecticut, United States
Smilow Cancer Hospital Care Center-Trumbull, Trumbull, Connecticut, United States
Beebe Medical Center, Lewes, Delaware, United States
Delaware Clinical and Laboratory Physicians PA, Newark, Delaware, United States
Helen F Graham Cancer Center, Newark, Delaware, United States
Medical Oncology Hematology Consultants PA, Newark, Delaware, United States
Regional Hematology and Oncology PA, Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
Beebe Health Campus, Rehoboth Beach, Delaware, United States
Nanticoke Memorial Hospital, Seaford, Delaware, United States
Christiana Care Health System-Wilmington Hospital, Wilmington, Delaware, United States
Saint Luke's Mountain States Tumor Institute, Boise, Idaho, United States
Kootenai Medical Center, Coeur d'Alene, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Fruitland, Fruitland, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Meridian, Meridian, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Nampa, Nampa, Idaho, United States
Kootenai Cancer Center, Post Falls, Idaho, United States
Kootenai Cancer Clinic, Sandpoint, Idaho, United States
Saint Luke's Mountain States Tumor Institute-Twin Falls, Twin Falls, Idaho, United States
Rush - Copley Medical Center, Aurora, Illinois, United States
Saint Joseph Medical Center, Bloomington, Illinois, United States
Illinois CancerCare-Bloomington, Bloomington, Illinois, United States
Illinois CancerCare-Canton, Canton, Illinois, United States
Memorial Hospital of Carbondale, Carbondale, Illinois, United States
SIH Cancer Institute, Carterville, Illinois, United States
Illinois CancerCare-Carthage, Carthage, Illinois, United States
Centralia Oncology Clinic, Centralia, Illinois, United States
John H Stroger Jr Hospital of Cook County, Chicago, Illinois, United States
Carle on Vermilion, Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur, Decatur, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Carle Physician Group-Effingham, Effingham, Illinois, United States
Crossroads Cancer Center, Effingham, Illinois, United States
Illinois CancerCare-Eureka, Eureka, Illinois, United States
Illinois CancerCare-Galesburg, Galesburg, Illinois, United States
Western Illinois Cancer Treatment Center, Galesburg, Illinois, United States
Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois, United States
Illinois CancerCare-Macomb, Macomb, Illinois, United States
Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, United States
Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, United States
Radiation Oncology of Northern Illinois, Ottawa, Illinois, United States
Illinois CancerCare-Pekin, Pekin, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center, Pekin, Illinois, United States
Illinois CancerCare-Peoria, Peoria, Illinois, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center, Peoria, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
OSF Saint Francis Medical Center, Peoria, Illinois, United States
Illinois CancerCare-Peru, Peru, Illinois, United States
Valley Radiation Oncology, Peru, Illinois, United States
Illinois CancerCare-Princeton, Princeton, Illinois, United States
Central Illinois Hematology Oncology Center, Springfield, Illinois, United States
Southern Illinois University School of Medicine, Springfield, Illinois, United States
Springfield Clinic, Springfield, Illinois, United States
Memorial Medical Center, Springfield, Illinois, United States
Cancer Care Specialists of Illinois-Swansea, Swansea, Illinois, United States
Southwest Illinois Health Services LLP, Swansea, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
The Carle Foundation Hospital, Urbana, Illinois, United States
Rush-Copley Healthcare Center, Yorkville, Illinois, United States
Deaconess Clinic Downtown, Evansville, Indiana, United States
Franciscan Saint Anthony Health-Michigan City, Michigan City, Indiana, United States
Woodland Cancer Care Center, Michigan City, Indiana, United States
Chancellor Center for Oncology, Newburgh, Indiana, United States
Reid Health, Richmond, Indiana, United States
Iowa Methodist Medical Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines, Des Moines, Iowa, United States
Broadlawns Medical Center, Des Moines, Iowa, United States
Iowa Lutheran Hospital, Des Moines, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Methodist West Hospital, West Des Moines, Iowa, United States
Oncology Hematology Care Inc-Crestview, Crestview Hills, Kentucky, United States
LSU Health Baton Rouge-North Clinic, Baton Rouge, Louisiana, United States
Louisiana Hematology Oncology Associates LLC, Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer Center, Baton Rouge, Louisiana, United States
Our Lady of the Lake Physicians Group - Medical Oncology, Baton Rouge, Louisiana, United States
Northshore Oncology Associates-Covington, Covington, Louisiana, United States
Oncology Center of The South Incorporated, Houma, Louisiana, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Henry Ford Cancer Institute?Downriver, Brownstown, Michigan, United States
Henry Ford Macomb Hospital-Clinton Township, Clinton Township, Michigan, United States
Henry Ford Medical Center-Fairlane, Dearborn, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
Allegiance Health, Jackson, Michigan, United States
Henry Ford Medical Center-Columbus, Novi, Michigan, United States
Henry Ford West Bloomfield Hospital, West Bloomfield, Michigan, United States
Sanford Joe Lueken Cancer Center, Bemidji, Minnesota, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy Hospital, Coon Rapids, Minnesota, United States
Fairview-Southdale Hospital, Edina, Minnesota, United States
Unity Hospital, Fridley, Minnesota, United States
Fairview Maple Grove Medical Center, Maple Grove, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast, Maplewood, Minnesota, United States
Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
Hennepin County Medical Center, Minneapolis, Minnesota, United States
Health Partners Inc, Minneapolis, Minnesota, United States
New Ulm Medical Center, New Ulm, Minnesota, United States
North Memorial Medical Health Center, Robbinsdale, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center, Shakopee, Minnesota, United States
Lakeview Hospital, Stillwater, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Rice Memorial Hospital, Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury, Woodbury, Minnesota, United States
Fairview Lakes Medical Center, Wyoming, Minnesota, United States
Parkland Health Center-Bonne Terre, Bonne Terre, Missouri, United States
Saint Francis Medical Center, Cape Girardeau, Missouri, United States
Southeast Cancer Center, Cape Girardeau, Missouri, United States
Siteman Cancer Center at West County Hospital, Creve Coeur, Missouri, United States
Capital Region Southwest Campus, Jefferson City, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Siteman Cancer Center-South County, Saint Louis, Missouri, United States
Missouri Baptist Medical Center, Saint Louis, Missouri, United States
Siteman Cancer Center at Saint Peters Hospital, Saint Peters, Missouri, United States
Sainte Genevieve County Memorial Hospital, Sainte Genevieve, Missouri, United States
Missouri Baptist Sullivan Hospital, Sullivan, Missouri, United States
Missouri Baptist Outpatient Center-Sunset Hills, Sunset Hills, Missouri, United States
Community Hospital of Anaconda, Anaconda, Montana, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Saint Vincent Healthcare, Billings, Montana, United States
Bozeman Deaconess Hospital, Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center, Butte, Montana, United States
Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, United States
Great Falls Clinic, Great Falls, Montana, United States
Saint Peter's Community Hospital, Helena, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Saint Patrick Hospital - Community Hospital, Missoula, Montana, United States
Community Medical Hospital, Missoula, Montana, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
Morristown Medical Center, Morristown, New Jersey, United States
Overlook Hospital, Summit, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Memorial Sloan Kettering Commack, Commack, New York, United States
Memorial Sloan Kettering Westchester, Harrison, New York, United States
Northwell Health/Center for Advanced Medicine, Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Memorial Sloan Kettering Rockville Centre, Rockville Centre, New York, United States
Sanford Bismarck Medical Center, Bismarck, North Dakota, United States
Roger Maris Cancer Center, Fargo, North Dakota, United States
Sanford Broadway Medical Center, Fargo, North Dakota, United States
Indu and Raj Soin Medical Center, Beavercreek, Ohio, United States
Dayton Physicians LLC-Miami Valley South, Centerville, Ohio, United States
Miami Valley Hospital South, Centerville, Ohio, United States
Oncology Hematology Care Inc-Eden Park, Cincinnati, Ohio, United States
Oncology Hematology Care Inc-Mercy West, Cincinnati, Ohio, United States
Oncology Hematology Care Inc - Anderson, Cincinnati, Ohio, United States
Oncology Hematology Care Inc-Kenwood, Cincinnati, Ohio, United States
Oncology Hematology Care Inc-Blue Ash, Cincinnati, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Good Samaritan Hospital - Dayton, Dayton, Ohio, United States
Miami Valley Hospital, Dayton, Ohio, United States
Dayton Physicians LLC-Samaritan North, Dayton, Ohio, United States
Miami Valley Hospital North, Dayton, Ohio, United States
Oncology Hematology Care Inc-Healthplex, Fairfield, Ohio, United States
Armes Family Cancer Center, Findlay, Ohio, United States
Blanchard Valley Hospital, Findlay, Ohio, United States
Orion Cancer Care, Findlay, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital, Franklin, Ohio, United States
Dayton Physicians LLC-Atrium, Franklin, Ohio, United States
Dayton Physicians LLC-Wayne, Greenville, Ohio, United States
Wayne Hospital, Greenville, Ohio, United States
Greater Dayton Cancer Center, Kettering, Ohio, United States
First Dayton Cancer Care, Kettering, Ohio, United States
Kettering Medical Center, Kettering, Ohio, United States
Dayton Physicians LLC-Signal Point, Middletown, Ohio, United States
Dayton Physicians LLC-Wilson, Sidney, Ohio, United States
Springfield Regional Cancer Center, Springfield, Ohio, United States
Springfield Regional Medical Center, Springfield, Ohio, United States
Dayton Physicians LLC-Upper Valley, Troy, Ohio, United States
Upper Valley Medical Center, Troy, Ohio, United States
Cancer Centers of Southwest Oklahoma Research, Lawton, Oklahoma, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Saint Charles Health System, Bend, Oregon, United States
Clackamas Radiation Oncology Center, Clackamas, Oregon, United States
Providence Oncology and Hematology Care Southeast, Clackamas, Oregon, United States
Bay Area Hospital, Coos Bay, Oregon, United States
Providence Newberg Medical Center, Newberg, Oregon, United States
Providence Willamette Falls Medical Center, Oregon City, Oregon, United States
Providence Portland Medical Center, Portland, Oregon, United States
Providence Saint Vincent Medical Center, Portland, Oregon, United States
Saint Charles Health System-Redmond, Redmond, Oregon, United States
UPMC-Heritage Valley Health System Beaver, Beaver, Pennsylvania, United States
Christiana Care Health System-Concord Health Center, Chadds Ford, Pennsylvania, United States
UPMC Cancer Centers - Arnold Palmer Pavilion, Greensburg, Pennsylvania, United States
Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
UPMC-Johnstown/John P. Murtha Regional Cancer Center, Johnstown, Pennsylvania, United States
UPMC Cancer Center at UPMC McKeesport, McKeesport, Pennsylvania, United States
UPMC-Coraopolis/Heritage Valley Radiation Oncology, Moon, Pennsylvania, United States
UPMC-Magee Womens Hospital, Pittsburgh, Pennsylvania, United States
UPMC-Presbyterian Hospital, Pittsburgh, Pennsylvania, United States
UPMC-Saint Margaret, Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
UPMC-Shadyside Hospital, Pittsburgh, Pennsylvania, United States
UPMC-Passavant Hospital, Pittsburgh, Pennsylvania, United States
UPMC-Saint Clair Hospital Cancer Center, Pittsburgh, Pennsylvania, United States
UPMC Cancer Center at UPMC Northwest, Seneca, Pennsylvania, United States
UPMC Uniontown Hospital Radiation Oncology, Uniontown, Pennsylvania, United States
UPMC Washington Hospital Radiation Oncology, Washington, Pennsylvania, United States
UPMC Susquehanna, Williamsport, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Greenville Health System Cancer Institute-Laurens, Clinton, South Carolina, United States
Greenville Health System Cancer Institute-Easley, Easley, South Carolina, United States
Greenville Health System Cancer Institute-Butternut, Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Faris, Greenville, South Carolina, United States
Greenville Memorial Hospital, Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Eastside, Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Greer, Greer, South Carolina, United States
Greenville Health System Cancer Institute-Seneca, Seneca, South Carolina, United States
Greenville Health System Cancer Institute-Spartanburg, Spartanburg, South Carolina, United States
Sanford Cancer Center Oncology Clinic, Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
Inova Fairfax Hospital-Woodburn Infusion Clinic, Annandale, Virginia, United States
Inova Fairfax Hospital, Falls Church, Virginia, United States
Providence Regional Cancer System-Aberdeen, Aberdeen, Washington, United States
Cancer Care Center at Island Hospital, Anacortes, Washington, United States
Swedish Cancer Institute-Eastside Oncology Hematology, Bellevue, Washington, United States
PeaceHealth Saint Joseph Medical Center, Bellingham, Washington, United States
Providence Regional Cancer System-Centralia, Centralia, Washington, United States
Swedish Medical Center-Edmonds, Edmonds, Washington, United States
Providence Regional Cancer Partnership, Everett, Washington, United States
Swedish Cancer Institute-Issaquah, Issaquah, Washington, United States
Kadlec Clinic Hematology and Oncology, Kennewick, Washington, United States
Providence Regional Cancer System-Lacey, Lacey, Washington, United States
PeaceHealth Saint John Medical Center, Longview, Washington, United States
Minor and James Medical PLLC, Seattle, Washington, United States
Pacific Gynecology Specialists, Seattle, Washington, United States
Swedish Medical Center-Ballard Campus, Seattle, Washington, United States
Kaiser Permanente Washington, Seattle, Washington, United States
Swedish Medical Center-First Hill, Seattle, Washington, United States
Swedish Medical Center-Cherry Hill, Seattle, Washington, United States
PeaceHealth United General Medical Center, Sedro-Woolley, Washington, United States
Providence Regional Cancer System-Shelton, Shelton, Washington, United States
Rockwood Clinic Cancer Treatment Center-Valley, Spokane Valley, Washington, United States
Rockwood Cancer Treatment Center-DHEC-Downtown, Spokane, Washington, United States
Rockwood North Cancer Treatment Center, Spokane, Washington, United States
PeaceHealth Southwest Medical Center, Vancouver, Washington, United States
Providence Saint Mary Regional Cancer Center, Walla Walla, Washington, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital, Yakima, Washington, United States
Providence Regional Cancer System-Yelm, Yelm, Washington, United States
Marshfield Clinic-Chippewa Center, Chippewa Falls, Wisconsin, United States
Marshfield Clinic Cancer Center - Eau Claire, Eau Claire, Wisconsin, United States
Marshfield Clinic Cancer Center at Sacred Heart, Eau Claire, Wisconsin, United States
Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
Marshfield Clinic - Ladysmith Center, Ladysmith, Wisconsin, United States
Marshfield Clinic, Marshfield, Wisconsin, United States
Marshfield Clinic-Minocqua Center, Minocqua, Wisconsin, United States
Cancer Center of Western Wisconsin, New Richmond, Wisconsin, United States
Marshfield Clinic-Rice Lake Center, Rice Lake, Wisconsin, United States
Marshfield Clinic Stevens Point Center, Stevens Point, Wisconsin, United States
Marshfield Clinic-Wausau Center, Wausau, Wisconsin, United States
Marshfield Clinic - Weston Center, Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids, Wisconsin, United States
Big Horn Basin Cancer Center, Cody, Wyoming, United States
Billings Clinic-Cody, Cody, Wyoming, United States
Welch Cancer Center, Sheridan, Wyoming, United States
Contact Details
Name: Alan Ho, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: STUDY_CHAIR
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