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Tazemetostat vid behandling av patienter med återkommande äggstockscancer eller endometriecancer

23 oktober 2026 uppdaterad av: National Cancer Institute (NCI)

En fas II-studie av Tazemetostat (EPZ-6438) (IND # 138671) vid återkommande eller persistent endometrioid eller klarcellig karcinom i äggstockarna och återkommande eller persistent endometrioid endometrial adenokarcinom

This phase II trial studies how well tazemetostat works in treating patients with ovarian or endometrial cancer that has come back (recurrent). Chemotherapy drugs, such as tazemetostat, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Detaljerad beskrivning

PRIMARY OBJECTIVES:

I. To assess the clinical activity (overall response rate) of tazemetostat in patients with recurrent or persistent endometrioid or clear cell ovarian carcinoma, and patients with recurrent or persistent endometrioid endometrial adenocarcinoma.

II. To assess the clinical activity (response frequency) of tazemetostat in patients with recurrent or persistent clear cell ovarian carcinoma with an ARID1A mutation.

SECONDARY OBJECTIVES:

I. To examine the nature and degree of toxicity in patients with this regimen. II. To examine the progression free survival and overall survival for this patient population receiving tazemetostat.

III. To examine the 6 month clinical benefit rate in patients treated with this regimen. (20-OCT-2021) IV. To evaluate BAF250a expression in patient samples as an indicator of ARID1A mutation status and correlation with the clinical response to study drug. Note: this only applies to patients enrolled prior to the 20-OCT-2021 version date. (20-OCT-2021)

EXPLORATORY OBJECTIVES:

I. Whether or not the patient has an ARID1A mutation. (08/13/2019) Note: this only applies to patients enrolled prior to the 20-OCT-2021 version date. (20-OCT-2021) (Translational Research Integrated Objective) II. To examine the correlation between ARID1A mutation and BAF250a expression and to identify potential mutations predictive of response in patients with preserved BAF250a expression. Note: this only applies to patients enrolled prior to the 20-OCT-2021 version date. (20-OCT-2021)

OUTLINE:

Patients receive tazemetostat orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) scans and magnetic resonance imaging (MRI) on study.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Studietyp

Interventionell

Inskrivning (Faktisk)

62

Fas

  • Fas 2

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      • Saginaw, Michigan, Förenta staterna, 48604
        • Oncology Hematology Associates of Saginaw Valley PC
      • Saginaw, Michigan, Förenta staterna, 48601
        • MyMichigan Medical Center Saginaw
      • Sterling Heights, Michigan, Förenta staterna, 48312
        • Bhadresh Nayak MD PC-Sterling Heights
      • Tawas City, Michigan, Förenta staterna, 48764
        • MyMichigan Medical Center Tawas
      • Warren, Michigan, Förenta staterna, 48088
        • Advanced Breast Care Center PLLC
      • Warren, Michigan, Förenta staterna, 48093
        • Macomb Hematology Oncology PC
      • Warren, Michigan, Förenta staterna, 48093
        • Henry Ford Madison Heights Hospital - Breast
      • Warren, Michigan, Förenta staterna, 48093
        • Henry Ford Health Warren Hospital
      • Warren, Michigan, Förenta staterna, 48093
        • Henry Ford Warren Hospital - GLCMS
      • West Branch, Michigan, Förenta staterna, 48661
        • Saint Mary's Oncology/Hematology Associates of West Branch
      • Ypsilanti, Michigan, Förenta staterna, 48197
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
      • Ypsilanti, Michigan, Förenta staterna, 48106
        • Huron Gastroenterology PC
    • Minnesota
      • Aitkin, Minnesota, Förenta staterna, 56431
        • Riverwood Healthcare Center
      • Baxter, Minnesota, Förenta staterna, 56425
        • Essentia Health - Baxter Clinic
      • Brainerd, Minnesota, Förenta staterna, 56401
        • Essentia Health Saint Joseph's Medical Center
      • Burnsville, Minnesota, Förenta staterna, 55337
        • Fairview Ridges Hospital
      • Burnsville, Minnesota, Förenta staterna, 55337
        • Minnesota Oncology - Burnsville
      • Cambridge, Minnesota, Förenta staterna, 55008
        • Cambridge Medical Center
      • Coon Rapids, Minnesota, Förenta staterna, 55433
        • Mercy Hospital
      • Deer River, Minnesota, Förenta staterna, 56636
        • Essentia Health - Deer River Clinic
      • Detroit Lakes, Minnesota, Förenta staterna, 56501
        • Essentia Health Saint Mary's - Detroit Lakes Clinic
      • Duluth, Minnesota, Förenta staterna, 55805
        • Essentia Health Cancer Center
      • Duluth, Minnesota, Förenta staterna, 55805
        • Essentia Health Saint Mary's Medical Center
      • Duluth, Minnesota, Förenta staterna, 55805
        • Miller-Dwan Hospital
      • Edina, Minnesota, Förenta staterna, 55435
        • Fairview Southdale Hospital
      • Ely, Minnesota, Förenta staterna, 55731
        • Essentia Health - Ely Clinic
      • Fergus Falls, Minnesota, Förenta staterna, 56537
        • Lake Region Healthcare Corporation-Cancer Care
      • Fosston, Minnesota, Förenta staterna, 56542
        • Essentia Health - Fosston
      • Fridley, Minnesota, Förenta staterna, 55432
        • Unity Hospital
      • Hibbing, Minnesota, Förenta staterna, 55746
        • Essentia Health Hibbing Clinic
      • International Falls, Minnesota, Förenta staterna, 56649
        • Essentia Health - International Falls Clinic
      • Maple Grove, Minnesota, Förenta staterna, 55369
        • Fairview Clinics and Surgery Center Maple Grove
      • Maplewood, Minnesota, Förenta staterna, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, Förenta staterna, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, Förenta staterna, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, Förenta staterna, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, Förenta staterna, 55454
        • Health Partners Inc
      • Monticello, Minnesota, Förenta staterna, 55362
        • Monticello Cancer Center
      • Moose Lake, Minnesota, Förenta staterna, 55767
        • Essentia Health - Moose Lake Clinic
      • New Ulm, Minnesota, Förenta staterna, 56073
        • New Ulm Medical Center
      • Park Rapids, Minnesota, Förenta staterna, 56470
        • Essentia Health - Park Rapids
      • Princeton, Minnesota, Förenta staterna, 55371
        • Fairview Northland Medical Center
      • Robbinsdale, Minnesota, Förenta staterna, 55422
        • North Memorial Medical Health Center
      • Rochester, Minnesota, Förenta staterna, 55905
        • Mayo Clinic in Rochester
      • Saint Louis Park, Minnesota, Förenta staterna, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, Förenta staterna, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, Förenta staterna, 55102
        • United Hospital
      • Sandstone, Minnesota, Förenta staterna, 55072
        • Essentia Health Sandstone
      • Shakopee, Minnesota, Förenta staterna, 55379
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, Förenta staterna, 55082
        • Lakeview Hospital
      • Virginia, Minnesota, Förenta staterna, 55792
        • Essentia Health Virginia Clinic
      • Waconia, Minnesota, Förenta staterna, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, Förenta staterna, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, Förenta staterna, 55125
        • Minnesota Oncology Hematology PA-Woodbury
      • Wyoming, Minnesota, Förenta staterna, 55092
        • Fairview Lakes Medical Center
    • Missouri
      • Ballwin, Missouri, Förenta staterna, 63011
        • Mercy Oncology and Hematology - Clayton-Clarkson
      • Bolivar, Missouri, Förenta staterna, 65613
        • Central Care Cancer Center - Bolivar
      • Bonne Terre, Missouri, Förenta staterna, 63628
        • Parkland Health Center-Bonne Terre
      • Branson, Missouri, Förenta staterna, 65616
        • Cox Cancer Center Branson
      • Cape Girardeau, Missouri, Förenta staterna, 63703
        • Saint Francis Medical Center
      • Cape Girardeau, Missouri, Förenta staterna, 63703
        • Mercy Cancer Center - Cape Girardeau
      • Farmington, Missouri, Förenta staterna, 63640
        • Parkland Health Center - Farmington
      • Jefferson City, Missouri, Förenta staterna, 65109
        • MU Health Care Goldschmidt Cancer Center
      • Joplin, Missouri, Förenta staterna, 64804
        • Freeman Health System
      • Joplin, Missouri, Förenta staterna, 64804
        • Mercy Hospital Joplin
      • Kansas City, Missouri, Förenta staterna, 64111
        • Saint Luke's Hospital of Kansas City
      • Lee's Summit, Missouri, Förenta staterna, 64086
        • Saint Luke's East - Lee's Summit
      • Rolla, Missouri, Förenta staterna, 65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Rolla, Missouri, Förenta staterna, 65401
        • Phelps Health Delbert Day Cancer Institute
      • Saint Joseph, Missouri, Förenta staterna, 64506
        • Heartland Regional Medical Center
      • Sainte Genevieve, Missouri, Förenta staterna, 63670
        • Sainte Genevieve County Memorial Hospital
      • Springfield, Missouri, Förenta staterna, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, Förenta staterna, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, Förenta staterna, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, Förenta staterna, 63131
        • Missouri Baptist Medical Center
      • St Louis, Missouri, Förenta staterna, 63109
        • Mercy Infusion Center - Chippewa
      • St Louis, Missouri, Förenta staterna, 63141
        • Mercy Hospital Saint Louis
      • St Louis, Missouri, Förenta staterna, 63128
        • Mercy Hospital South
      • Sullivan, Missouri, Förenta staterna, 63080
        • Missouri Baptist Sullivan Hospital
      • Washington, Missouri, Förenta staterna, 63090
        • Mercy Hospital Washington
    • Montana
      • Anaconda, Montana, Förenta staterna, 59711
        • Community Hospital of Anaconda
      • Billings, Montana, Förenta staterna, 59101
        • Billings Clinic Cancer Center
      • Bozeman, Montana, Förenta staterna, 59715
        • Bozeman Health Deaconess Hospital
      • Great Falls, Montana, Förenta staterna, 59405
        • Great Falls Clinic
      • Great Falls, Montana, Förenta staterna, 59405
        • Benefis Sletten Cancer Institute
      • Helena, Montana, Förenta staterna, 59601
        • Saint Peter's Community Hospital
      • Kalispell, Montana, Förenta staterna, 59901
        • Logan Health Medical Center
      • Missoula, Montana, Förenta staterna, 59802
        • Saint Patrick Hospital - Community Hospital
      • Missoula, Montana, Förenta staterna, 59804
        • Community Medical Center
    • Nebraska
      • Grand Island, Nebraska, Förenta staterna, 68803
        • Nebraska Cancer Specialists/Oncology Hematology West PC
      • Kearney, Nebraska, Förenta staterna, 68847
        • CHI Health Good Samaritan
      • Lincoln, Nebraska, Förenta staterna, 68510
        • Saint Elizabeth Regional Medical Center
      • Omaha, Nebraska, Förenta staterna, 68114
        • Nebraska Methodist Hospital
      • Omaha, Nebraska, Förenta staterna, 68198
        • University of Nebraska Medical Center
      • Omaha, Nebraska, Förenta staterna, 68124
        • Alegent Health Bergan Mercy Medical Center
      • Omaha, Nebraska, Förenta staterna, 68118
        • Nebraska Medicine-Village Pointe
      • Omaha, Nebraska, Förenta staterna, 68122
        • Alegent Health Immanuel Medical Center
      • Omaha, Nebraska, Förenta staterna, 68130
        • Alegent Health Lakeside Hospital
      • Omaha, Nebraska, Förenta staterna, 68114
        • Oncology Associates PC
      • Omaha, Nebraska, Förenta staterna, 68114
        • Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
      • Papillion, Nebraska, Förenta staterna, 68046
        • Midlands Community Hospital
    • Nevada
      • Carson City, Nevada, Förenta staterna, 89703
        • Carson Tahoe Regional Medical Center
      • Henderson, Nevada, Förenta staterna, 89052
        • Comprehensive Cancer Centers of Nevada - Henderson
      • Henderson, Nevada, Förenta staterna, 89052
        • Cancer and Blood Specialists-Henderson
      • Henderson, Nevada, Förenta staterna, 89052
        • Las Vegas Cancer Center-Henderson
      • Henderson, Nevada, Förenta staterna, 89074
        • Comprehensive Cancer Centers of Nevada-Southeast Henderson
      • Henderson, Nevada, Förenta staterna, 89052
        • Comprehensive Cancer Centers of Nevada-Horizon Ridge
      • Henderson, Nevada, Förenta staterna, 89074
        • Las Vegas Urology - Green Valley
      • Henderson, Nevada, Förenta staterna, 89074
        • Las Vegas Urology - Pebble
      • Henderson, Nevada, Förenta staterna, 89074
        • Urology Specialists of Nevada - Green Valley
      • Henderson, Nevada, Förenta staterna, 89074
        • Oncology Las Vegas - Henderson
      • Las Vegas, Nevada, Förenta staterna, 89144
        • Summerlin Hospital Medical Center
      • Las Vegas, Nevada, Förenta staterna, 89109
        • Sunrise Hospital and Medical Center
      • Las Vegas, Nevada, Förenta staterna, 89102
        • OptumCare Cancer Care at Charleston
      • Las Vegas, Nevada, Förenta staterna, 89106
        • Radiation Oncology Centers of Nevada Central
      • Las Vegas, Nevada, Förenta staterna, 89119
        • Radiation Oncology Centers of Nevada Southeast
      • Las Vegas, Nevada, Förenta staterna, 89128
        • Comprehensive Cancer Centers of Nevada - Northwest
      • Las Vegas, Nevada, Förenta staterna, 89128
        • OptumCare Cancer Care at MountainView
      • Las Vegas, Nevada, Förenta staterna, 89135
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
      • Las Vegas, Nevada, Förenta staterna, 89144
        • Comprehensive Cancer Centers of Nevada - Town Center
      • Las Vegas, Nevada, Förenta staterna, 89144
        • Comprehensive Cancer Centers of Nevada-Summerlin
      • Las Vegas, Nevada, Förenta staterna, 89148
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Förenta staterna, 89169
        • Comprehensive Cancer Centers of Nevada - Central Valley
      • Las Vegas, Nevada, Förenta staterna, 89106
        • Women's Cancer Center of Nevada
      • Las Vegas, Nevada, Förenta staterna, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, Förenta staterna, 89106
        • Cancer and Blood Specialists-Shadow
      • Las Vegas, Nevada, Förenta staterna, 89109
        • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
      • Las Vegas, Nevada, Förenta staterna, 89113
        • HealthCare Partners Medical Group Oncology/Hematology-San Martin
      • Las Vegas, Nevada, Förenta staterna, 89128
        • Cancer and Blood Specialists-Tenaya
      • Las Vegas, Nevada, Förenta staterna, 89128
        • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
      • Las Vegas, Nevada, Förenta staterna, 89148-2405
        • Las Vegas Cancer Center-Medical Center
      • Las Vegas, Nevada, Förenta staterna, 89149
        • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
      • Las Vegas, Nevada, Förenta staterna, 89128
        • Ann M Wierman MD LTD
      • Las Vegas, Nevada, Förenta staterna, 89074
        • Las Vegas Urology - Pecos
      • Las Vegas, Nevada, Förenta staterna, 89102
        • Desert West Surgery
      • Las Vegas, Nevada, Förenta staterna, 89103
        • Hope Cancer Care of Nevada
      • Las Vegas, Nevada, Förenta staterna, 89106
        • Urology Specialists of Nevada - Central
      • Las Vegas, Nevada, Förenta staterna, 89113
        • Las Vegas Prostate Cancer Center
      • Las Vegas, Nevada, Förenta staterna, 89113
        • Las Vegas Urology - Sunset
      • Las Vegas, Nevada, Förenta staterna, 89128
        • Las Vegas Urology - Cathedral Rock
      • Las Vegas, Nevada, Förenta staterna, 89128
        • Las Vegas Urology - Smoke Ranch
      • Las Vegas, Nevada, Förenta staterna, 89128
        • Urology Specialists of Nevada - Northwest
      • Las Vegas, Nevada, Förenta staterna, 89169
        • University Cancer Center
      • Las Vegas, Nevada, Förenta staterna, 89113
        • Urology Specialists of Nevada - Southwest
      • Las Vegas, Nevada, Förenta staterna, 89128
        • Oncology Las Vegas - Tenaya
      • Las Vegas, Nevada, Förenta staterna, 89183
        • OptumCare Cancer Care at Fort Apache
      • Pahrump, Nevada, Förenta staterna, 89048
        • Hope Cancer Care of Nevada-Pahrump
      • Reno, Nevada, Förenta staterna, 89502
        • Renown Regional Medical Center
      • Reno, Nevada, Förenta staterna, 89503
        • Saint Mary's Regional Medical Center
      • Reno, Nevada, Förenta staterna, 89509
        • Radiation Oncology Associates
    • New Jersey
      • Basking Ridge, New Jersey, Förenta staterna, 07920
        • Memorial Sloan Kettering Basking Ridge
      • Middletown, New Jersey, Förenta staterna, 07748
        • Memorial Sloan Kettering Monmouth
      • Montvale, New Jersey, Förenta staterna, 07645
        • Memorial Sloan Kettering Bergen
    • New York
      • Commack, New York, Förenta staterna, 11725
        • Memorial Sloan Kettering Commack
      • Harrison, New York, Förenta staterna, 10604
        • Memorial Sloan Kettering Westchester
      • New York, New York, Förenta staterna, 10065
        • Memorial Sloan Kettering Cancer Center
      • Rochester, New York, Förenta staterna, 14642
        • University of Rochester
      • Uniondale, New York, Förenta staterna, 11553
        • Memorial Sloan Kettering Nassau
    • North Dakota
      • Fargo, North Dakota, Förenta staterna, 58103
        • Essentia Health Cancer Center-South University Clinic
      • Jamestown, North Dakota, Förenta staterna, 58401
        • Essentia Health - Jamestown Clinic
    • Ohio
      • Alliance, Ohio, Förenta staterna, 44601
        • Aultman Alliance Community Hospital
      • Beachwood, Ohio, Förenta staterna, 44122
        • UHHS-Chagrin Highlands Medical Center
      • Beavercreek, Ohio, Förenta staterna, 45431
        • Indu and Raj Soin Medical Center
      • Belpre, Ohio, Förenta staterna, 45714
        • Strecker Cancer Center-Belpre
      • Boardman, Ohio, Förenta staterna, 44512
        • Saint Elizabeth Boardman Hospital
      • Canton, Ohio, Förenta staterna, 44710
        • Aultman Health Foundation
      • Centerville, Ohio, Förenta staterna, 45459
        • Miami Valley Hospital South
      • Centerville, Ohio, Förenta staterna, 45459
        • Dayton Physicians LLC-Miami Valley South
      • Chardon, Ohio, Förenta staterna, 44024
        • Geauga Hospital
      • Chillicothe, Ohio, Förenta staterna, 45601
        • Adena Regional Medical Center
      • Cincinnati, Ohio, Förenta staterna, 45219
        • University of Cincinnati Cancer Center-UC Medical Center
      • Cincinnati, Ohio, Förenta staterna, 45220
        • Good Samaritan Hospital - Cincinnati
      • Cincinnati, Ohio, Förenta staterna, 45242
        • Bethesda North Hospital
      • Cincinnati, Ohio, Förenta staterna, 45236
        • Oncology Hematology Care Inc-Kenwood
      • Cincinnati, Ohio, Förenta staterna, 45247
        • TriHealth Cancer Institute-Westside
      • Cincinnati, Ohio, Förenta staterna, 45255
        • TriHealth Cancer Institute-Anderson
      • Cleveland, Ohio, Förenta staterna, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, Förenta staterna, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, Förenta staterna, 44111
        • Cleveland Clinic Cancer Center/Fairview Hospital
      • Columbus, Ohio, Förenta staterna, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, Förenta staterna, 43210
        • Ohio State University Comprehensive Cancer Center
      • Columbus, Ohio, Förenta staterna, 43219
        • The Mark H Zangmeister Center
      • Columbus, Ohio, Förenta staterna, 43214
        • Columbus Oncology and Hematology Associates Inc
      • Columbus, Ohio, Förenta staterna, 43228
        • Doctors Hospital
      • Columbus, Ohio, Förenta staterna, 43213
        • Mount Carmel East Hospital
      • Columbus, Ohio, Förenta staterna, 43215
        • Grant Medical Center
      • Columbus, Ohio, Förenta staterna, 43222
        • Mount Carmel Health Center West
      • Dayton, Ohio, Förenta staterna, 45406
        • Good Samaritan Hospital - Dayton
      • Dayton, Ohio, Förenta staterna, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, Förenta staterna, 45415
        • Miami Valley Hospital North
      • Dayton, Ohio, Förenta staterna, 45405
        • Grandview Hospital
      • Dayton, Ohio, Förenta staterna, 45415
        • Dayton Physician LLC - Englewood
      • Delaware, Ohio, Förenta staterna, 43015
        • Delaware Health Center-Grady Cancer Center
      • Delaware, Ohio, Förenta staterna, 43015
        • Grady Memorial Hospital
      • Dublin, Ohio, Förenta staterna, 43016
        • Dublin Methodist Hospital
      • Dublin, Ohio, Förenta staterna, 43016
        • Columbus Oncology and Hematology Associates
      • Findlay, Ohio, Förenta staterna, 45840
        • Blanchard Valley Hospital
      • Findlay, Ohio, Förenta staterna, 45840
        • Armes Family Cancer Center
      • Findlay, Ohio, Förenta staterna, 45840
        • Orion Cancer Care
      • Franklin, Ohio, Förenta staterna, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Franklin, Ohio, Förenta staterna, 45005
        • Dayton Physicians LLC-Atrium
      • Gahanna, Ohio, Förenta staterna, 43230
        • Central Ohio Breast and Endocrine Surgery
      • Greenville, Ohio, Förenta staterna, 45331
        • Wayne Hospital
      • Greenville, Ohio, Förenta staterna, 45331
        • Dayton Physicians LLC-Wayne
      • Grove City, Ohio, Förenta staterna, 43123
        • Mount Carmel Grove City Hospital
      • Kettering, Ohio, Förenta staterna, 45429
        • Kettering Medical Center
      • Kettering, Ohio, Förenta staterna, 45409
        • Greater Dayton Cancer Center
      • Kettering, Ohio, Förenta staterna, 45420
        • First Dayton Cancer Care
      • Lancaster, Ohio, Förenta staterna, 43130
        • Fairfield Medical Center
      • Lima, Ohio, Förenta staterna, 45801
        • Saint Rita's Medical Center
      • Mansfield, Ohio, Förenta staterna, 44903
        • OhioHealth Mansfield Hospital
      • Marietta, Ohio, Förenta staterna, 45750
        • Marietta Memorial Hospital
      • Marion, Ohio, Förenta staterna, 43302
        • OhioHealth Marion General Hospital
      • Mayfield Heights, Ohio, Förenta staterna, 44124
        • Hillcrest Hospital Cancer Center
      • Mount Vernon, Ohio, Förenta staterna, 43050
        • Knox Community Hospital
      • New Albany, Ohio, Förenta staterna, 43054
        • Mount Carmel New Albany Surgical Hospital
      • Newark, Ohio, Förenta staterna, 43055
        • Licking Memorial Hospital
      • Newark, Ohio, Förenta staterna, 43055
        • Newark Radiation Oncology
      • Perrysburg, Ohio, Förenta staterna, 43551
        • Mercy Health - Perrysburg Hospital
      • Portsmouth, Ohio, Förenta staterna, 45662
        • Southern Ohio Medical Center
      • Springfield, Ohio, Förenta staterna, 45504
        • Springfield Regional Cancer Center
      • Springfield, Ohio, Förenta staterna, 45504
        • Springfield Regional Medical Center
      • Sylvania, Ohio, Förenta staterna, 43560
        • ProMedica Flower Hospital
      • Toledo, Ohio, Förenta staterna, 43606
        • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
      • Toledo, Ohio, Förenta staterna, 43623
        • Mercy Health - Saint Anne Hospital
      • Toledo, Ohio, Förenta staterna, 43608
        • Mercy Health - Saint Vincent Hospital
      • Toledo, Ohio, Förenta staterna, 43623
        • Mercy Health Sylvania Radiation Oncology Center
      • Troy, Ohio, Förenta staterna, 45373
        • Upper Valley Medical Center
      • Troy, Ohio, Förenta staterna, 45373
        • Dayton Physicians LLC - Troy
      • Wadsworth, Ohio, Förenta staterna, 44281
        • University Hospitals Sharon Health Center
      • Warren, Ohio, Förenta staterna, 44484
        • Saint Joseph Warren Hospital
      • West Chester, Ohio, Förenta staterna, 45069
        • University of Cincinnati Cancer Center-West Chester
      • Westerville, Ohio, Förenta staterna, 43081
        • Saint Ann's Hospital
      • Westlake, Ohio, Förenta staterna, 44145
        • UH Seidman Cancer Center at Saint John Medical Center
      • Westlake, Ohio, Förenta staterna, 44145
        • UHHS-Westlake Medical Center
      • Youngstown, Ohio, Förenta staterna, 44501
        • Saint Elizabeth Youngstown Hospital
      • Zanesville, Ohio, Förenta staterna, 43701
        • Genesis Healthcare System Cancer Care Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Förenta staterna, 73104
        • University of Oklahoma Health Sciences Center
      • Oklahoma City, Oklahoma, Förenta staterna, 73120
        • Mercy Hospital Oklahoma City
      • Tulsa, Oklahoma, Förenta staterna, 74146
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
    • Oregon
      • Baker City, Oregon, Förenta staterna, 97814
        • Saint Alphonsus Cancer Care Center-Baker City
      • Bend, Oregon, Förenta staterna, 97701
        • Saint Charles Health System
      • Clackamas, Oregon, Förenta staterna, 97015
        • Clackamas Radiation Oncology Center
      • Clackamas, Oregon, Förenta staterna, 97015
        • Providence Cancer Institute Clackamas Clinic
      • Coos Bay, Oregon, Förenta staterna, 97420
        • Bay Area Hospital
      • Newberg, Oregon, Förenta staterna, 97132
        • Providence Newberg Medical Center
      • Ontario, Oregon, Förenta staterna, 97914
        • Saint Alphonsus Cancer Care Center-Ontario
      • Portland, Oregon, Förenta staterna, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, Förenta staterna, 97225
        • Providence Saint Vincent Medical Center
      • Redmond, Oregon, Förenta staterna, 97756
        • Saint Charles Health System-Redmond
    • Pennsylvania
      • Allentown, Pennsylvania, Förenta staterna, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Bethlehem, Pennsylvania, Förenta staterna, 18017
        • Lehigh Valley Hospital - Muhlenberg
      • Danville, Pennsylvania, Förenta staterna, 17822
        • Geisinger Medical Center
      • East Stroudsburg, Pennsylvania, Förenta staterna, 18301
        • Pocono Medical Center
      • Hazleton, Pennsylvania, Förenta staterna, 18201
        • Geisinger Medical Center-Cancer Center Hazleton
      • Hazleton, Pennsylvania, Förenta staterna, 18201
        • Lehigh Valley Hospital-Hazleton
      • Jefferson Hills, Pennsylvania, Förenta staterna, 15025
        • Jefferson Hospital
      • Lewisburg, Pennsylvania, Förenta staterna, 17837
        • Geisinger Medical Oncology-Lewisburg
      • Lewistown, Pennsylvania, Förenta staterna, 17044
        • Lewistown Hospital
      • Monroeville, Pennsylvania, Förenta staterna, 15146
        • Forbes Hospital
      • Philadelphia, Pennsylvania, Förenta staterna, 19107
        • Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, Förenta staterna, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, Förenta staterna, 15224
        • West Penn Hospital
      • Pottsville, Pennsylvania, Förenta staterna, 17901
        • Geisinger Cancer Services-Pottsville
      • Scranton, Pennsylvania, Förenta staterna, 18510
        • Community Medical Center
      • Selinsgrove, Pennsylvania, Förenta staterna, 17870
        • Geisinger Medical Oncology-Selinsgrove
      • State College, Pennsylvania, Förenta staterna, 16801
        • Geisinger Medical Group
      • Wexford, Pennsylvania, Förenta staterna, 15090
        • Wexford Health and Wellness Pavilion
      • Wilkes-Barre, Pennsylvania, Förenta staterna, 18711
        • Geisinger Wyoming Valley/Henry Cancer Center
      • Willow Grove, Pennsylvania, Förenta staterna, 19090
        • Asplundh Cancer Pavilion
    • Rhode Island
      • Providence, Rhode Island, Förenta staterna, 02905
        • Women and Infants Hospital
    • South Carolina
      • Charleston, South Carolina, Förenta staterna, 29425
        • Medical University of South Carolina
    • South Dakota
      • Rapid City, South Dakota, Förenta staterna, 57701
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, Förenta staterna, 57105
        • Avera Cancer Institute
    • Texas
      • Bryan, Texas, Förenta staterna, 77802
        • Saint Joseph Regional Cancer Center
      • Dallas, Texas, Förenta staterna, 75235
        • Parkland Memorial Hospital
      • Dallas, Texas, Förenta staterna, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
    • Utah
      • Salt Lake City, Utah, Förenta staterna, 84112
        • Huntsman Cancer Institute/University of Utah
    • Virginia
      • Charlottesville, Virginia, Förenta staterna, 22908
        • University of Virginia Cancer Center
      • Mechanicsville, Virginia, Förenta staterna, 23116
        • Bon Secours Memorial Regional Medical Center
      • Midlothian, Virginia, Förenta staterna, 23114
        • Bon Secours Saint Francis Medical Center
      • Midlothian, Virginia, Förenta staterna, 23113
        • Bon Secours Westchester Emergency Center
      • Norfolk, Virginia, Förenta staterna, 23505
        • Bon Secours DePaul Medical Center
      • Portsmouth, Virginia, Förenta staterna, 23707
        • Bon Secours Maryview Medical Center
      • Richmond, Virginia, Förenta staterna, 23226
        • Bon Secours Saint Mary's Hospital
      • Richmond, Virginia, Förenta staterna, 23230
        • Bon Secours Cancer Institute at Reynolds Crossing
      • Suffolk, Virginia, Förenta staterna, 23435
        • Bon Secours Health Center at Harbour View
    • Washington
      • Aberdeen, Washington, Förenta staterna, 98520
        • Providence Regional Cancer System-Aberdeen
      • Bellevue, Washington, Förenta staterna, 98004
        • Overlake Medical Center
      • Bellingham, Washington, Förenta staterna, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Burien, Washington, Förenta staterna, 98166
        • Saint Anne Hospital
      • Centralia, Washington, Förenta staterna, 98531
        • Providence Regional Cancer System-Centralia
      • Edmonds, Washington, Förenta staterna, 98026
        • Swedish Cancer Institute-Edmonds
      • Enumclaw, Washington, Förenta staterna, 98022
        • Saint Elizabeth Hospital
      • Everett, Washington, Förenta staterna, 98201
        • Providence Regional Cancer Partnership
      • Federal Way, Washington, Förenta staterna, 98003
        • Saint Francis Hospital
      • Issaquah, Washington, Förenta staterna, 98029
        • Swedish Cancer Institute-Issaquah
      • Kennewick, Washington, Förenta staterna, 99336
        • Kadlec Clinic Hematology and Oncology
      • Lacey, Washington, Förenta staterna, 98503
        • Providence Regional Cancer System-Lacey
      • Lakewood, Washington, Förenta staterna, 98499
        • Saint Clare Hospital
      • Longview, Washington, Förenta staterna, 98632
        • PeaceHealth Saint John Medical Center
      • Renton, Washington, Förenta staterna, 98055
        • Valley Medical Center
      • Seattle, Washington, Förenta staterna, 98107
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, Förenta staterna, 98122
        • Swedish Medical Center-First Hill
      • Seattle, Washington, Förenta staterna, 98112
        • Kaiser Permanente Washington
      • Seattle, Washington, Förenta staterna, 98104
        • Pacific Gynecology Specialists
      • Seattle, Washington, Förenta staterna, 98122-5711
        • Swedish Medical Center-Cherry Hill
      • Sedro-Woolley, Washington, Förenta staterna, 98284
        • PeaceHealth United General Medical Center
      • Shelton, Washington, Förenta staterna, 98584
        • Providence Regional Cancer System-Shelton
      • Silverdale, Washington, Förenta staterna, 98383
        • Saint Joseph Medical Center Hematology and Oncology - Silverdale
      • Tacoma, Washington, Förenta staterna, 98405
        • Franciscan Research Center-Northwest Medical Plaza
      • Vancouver, Washington, Förenta staterna, 98664
        • PeaceHealth Southwest Medical Center
      • Walla Walla, Washington, Förenta staterna, 99362
        • Providence Saint Mary Regional Cancer Center
      • Yakima, Washington, Förenta staterna, 98902
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
      • Yelm, Washington, Förenta staterna, 98597
        • Providence Regional Cancer System-Yelm
    • Wisconsin
      • Ashland, Wisconsin, Förenta staterna, 54806
        • Duluth Clinic Ashland
      • Ashland, Wisconsin, Förenta staterna, 54806
        • Northwest Wisconsin Cancer Center
      • Burlington, Wisconsin, Förenta staterna, 53105
        • Aurora Cancer Care-Southern Lakes VLCC
      • Fond du Lac, Wisconsin, Förenta staterna, 54937
        • Aurora Health Center-Fond du Lac
      • Germantown, Wisconsin, Förenta staterna, 53022
        • Aurora Health Care Germantown Health Center
      • Grafton, Wisconsin, Förenta staterna, 53024
        • Aurora Cancer Care-Grafton
      • Green Bay, Wisconsin, Förenta staterna, 54311
        • Aurora BayCare Medical Center
      • Hayward, Wisconsin, Förenta staterna, 54843
        • Essentia Health-Hayward Clinic
      • Kenosha, Wisconsin, Förenta staterna, 53142
        • Aurora Cancer Care-Kenosha South
      • La Crosse, Wisconsin, Förenta staterna, 54601
        • Gundersen Lutheran Medical Center
      • Marinette, Wisconsin, Förenta staterna, 54143
        • Aurora Bay Area Medical Group-Marinette
      • Milwaukee, Wisconsin, Förenta staterna, 53209
        • Aurora Cancer Care-Milwaukee
      • Milwaukee, Wisconsin, Förenta staterna, 53215
        • Aurora Saint Luke's Medical Center
      • Milwaukee, Wisconsin, Förenta staterna, 53233
        • Aurora Sinai Medical Center
      • Mukwonago, Wisconsin, Förenta staterna, 53149
        • ProHealth D N Greenwald Center
      • New Richmond, Wisconsin, Förenta staterna, 54017
        • Cancer Center of Western Wisconsin
      • Oconomowoc, Wisconsin, Förenta staterna, 53066
        • ProHealth Oconomowoc Memorial Hospital
      • Oshkosh, Wisconsin, Förenta staterna, 54904
        • Vince Lombardi Cancer Clinic - Oshkosh
      • Racine, Wisconsin, Förenta staterna, 53406
        • Aurora Cancer Care-Racine
      • Sheboygan, Wisconsin, Förenta staterna, 53081
        • Vince Lombardi Cancer Clinic-Sheboygan
      • Spooner, Wisconsin, Förenta staterna, 54801
        • Essentia Health-Spooner Clinic
      • Summit, Wisconsin, Förenta staterna, 53066
        • Aurora Medical Center in Summit
      • Superior, Wisconsin, Förenta staterna, 54880
        • Essentia Health Saint Mary's Hospital - Superior
      • Two Rivers, Wisconsin, Förenta staterna, 54241
        • Vince Lombardi Cancer Clinic-Two Rivers
      • Waukesha, Wisconsin, Förenta staterna, 53188
        • UW Cancer Center at ProHealth Care
      • Waukesha, Wisconsin, Förenta staterna, 53188
        • ProHealth Waukesha Memorial Hospital
      • Wauwatosa, Wisconsin, Förenta staterna, 53226
        • Aurora Cancer Care-Milwaukee West
      • West Allis, Wisconsin, Förenta staterna, 53227
        • Aurora West Allis Medical Center
    • Wyoming
      • Cody, Wyoming, Förenta staterna, 82414
        • Billings Clinic-Cody
      • Sheridan, Wyoming, Förenta staterna, 82801
        • Welch Cancer Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

Inclusion Criteria:

  • Pathologically (histologically or cytologically) proven diagnosis of recurrent or persistent ovarian endometrioid or clear cell carcinoma, OR recurrent or persistent endometrioid endometrial adenocarcinoma; patients with recurrent endometrial cancer must have mismatch repair (MMR) immunohistochemistry completed; if they are found to be mismatch repair deficient, they should be offered treatment with immune checkpoint inhibition before consideration for treatment on trial; primary ovarian tumors must be at least 50% endometrioid or clear cell morphology, or have histologically documented recurrence with at least 50% endometrioid or clear cell morphology; institutional pathology reports must be provided indicating at least 50% endometrioid or clear cell morphology for ovarian tumors (primary or recurrent lesions)

    • Only patients with recurrent or persistent ovarian clear cell carcinoma (OCCC) with ARID1A pathologic variant or likely pathologic variant mutations per next generation sequencing (NGS) are eligible for entry (20-OCT-2021)
    • Institutional pathology reports must be provided indicating at least 50% clear cell morphology for ovarian tumors (primary or recurrent lesions) and NGS report must be available for step 1 registration (20-OCT-2021) (09-DEC-2021)
    • All other eligibility criteria and ineligibility criteria must be met for step 2 registration (20-OCT-2021) (09-DEC-2021)
  • All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI

  • Patients must have had at least one, but no more than 3, prior cytotoxic regimens for management of primary disease; unlimited prior hormonal therapy, targeted therapy (including immunotherapy) or antiangiogenic therapy will be permitted

  • Patients must have completed prior therapy:

    • Chemotherapy: cytotoxic

      • At least 28 days since last dose of chemotherapy prior to step 2 registration.
    • Chemotherapy: nitrosoureas

      • At least 6 weeks since last dose of chemotherapy prior to step 2 registration.
    • Chemotherapy: non-cytotoxic (e.g. small molecule inhibitor)

      • At least 28 days since last dose of chemotherapy prior to step 2 registration.
    • Monoclonal antibody(ies)

      • At least 28 days since last dose of monoclonal antibody prior to step 2 registration.
    • Immunotherapy

      • At least 28 days since last dose of immunotherapy prior to step 2 registration.
    • Radiotherapy (RT)

      • At least 14 days from last local site RT prior to step 2 registration.
      • At least 21 days from stereotactic radiosurgery prior to step 2 registration.
      • At least 12 weeks from craniospinal, >= 50% radiation of pelvis or total body irradiation prior to step 2 registration.
      • Patients with central nervous system (CNS) disease should demonstrate evidence of stabilization after the 28-day time point after definitive treatment.
      • Full recovery of radiation related side effects prior to step 2 registration.
      • All subjects must have evidence of measurable disease outside of the radiation field at the time of step 2 registration
  • Appropriate stage for study entry based on the following diagnostic workup:

    • History/physical examination within 14 days prior to step 2 registration
    • Imaging of the chest, abdomen and pelvis within 28 days prior to step 2 registration
  • Age >= 18

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to step 2 registration

  • Platelets >= 100,000/mcl (within 14 days prior to step 2 registration)

  • Absolute neutrophil count (ANC) >= 1,500/mcl (within 14 days prior to step 2 registration)

  • Hemoglobin >= 8 g/dL (within 14 days prior to step 2 registration)

  • Differential with no clinically significant morphologic abnormalities on complete blood count (CBC) testing; manual differential is encouraged, if clinically indicated, and in cases where an automated differential is abnormal (within 14 days prior to step 2 registration)

  • Creatinine =< 1.5 x institutional/laboratory upper limit of normal (ULN) (within 14 days prior to step 2 registration)

  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (within 14 days prior to step 2 registration)

  • Total serum bilirubin level =< 1.5 x ULN; direct bilirubin =< ULN for subjects with total bilirubin > 1.5 x ULN (patients with isolated indirect bilirubin elevations and a history of Gilbert's syndrome are eligible) (within 14 days prior to step 2 registration)

  • Patients must be able to swallow and retain oral medications and not have gastrointestinal illnesses that would preclude absorption of tazemetostat as judged by the treating physician (20-OCT-2021)

  • Women of childbearing potential must be willing and able to use adequate contraception (hormonal and barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after the last dose of study agent; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately; theoretically, CYP3A induction with tazemetostat use may result in the loss of efficacy in hormonal contraceptives, thus a barrier method of contraception must be used in addition to hormonal contraceptives due to the potential drug-drug interaction with tazemetostat (20-OCT-2021)

  • The patient or a legally authorized representative must provide study-specific informed consent and authorization permitting release of personal health information prior to study entry

  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial (08/13/2019)

Exclusion Criteria:

  • Prior treatment with an investigational EZH2 inhibitor
  • A prior history of myeloid malignancies, including myelodysplastic syndrome (MDS)
  • Abnormalities known to be associated with MDS (e.g. del 5q, chr 7 abn) and myeloproliferative neoplasms (MPN) (e.g. JAK2 V617F) observed in cytogenetic testing and deoxyribonucleic acid (DNA) sequencing
  • A prior history of T-cell lymphoblastic lymphoma (T-LBL)/T-cell acute lymphoblastic leukemia (T-ALL)
  • Patients who have had therapeutic paracentesis or thoracentesis within 8 weeks prior to step 2 registration (20-OCT-2021)
  • Patients with clinical or radiographic evidence of bowel obstruction (20-OCT-2021)
  • Severe, active co-morbidity per the treating investigator's discretion
  • Pregnant or lactating patients
  • Known human immunodeficiency virus (HIV) positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with tazemetostat; in addition, treatments involved in this protocol may be immunosuppressive, increasing the risk of lethal infections in this patient population
  • Treatment with strong and moderate inhibitors or inducers of CYP3A within 14 days of step 2 registration and during the study treatment (20-OCT-2021)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Treatment (tazemetostat)

Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and MRI on study.

Undergo MRI

Andra namn:
  • MRI
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medicinsk bildbehandling, magnetisk resonans / kärnmagnetisk resonans
  • HERR
  • MR-avbildning
  • MRI-skanning
  • NMR-avbildning
  • NMRI
  • Kärnmagnetisk resonanstomografi
  • Magnetisk resonanstomografi (MRT)
  • sMRI
  • Magnetisk resonanstomografi (förfarande)
  • Strukturell MRI

Undergo CT scan

Andra namn:
  • CT
  • KATT
  • Datortomografi
  • Beräknad axiell tomografi
  • Datoriserad axialtomografi
  • tomografi
  • Datoriserad axiell tomografi (förfarande)
  • Datortomografi (CT) skanning
  • Diagnostisk kattskanning
  • Diagnostisk kattskanningstjänsttyp

Given PO

Andra namn:
  • EPZ-6438
  • E7438
  • EPZ6438
  • E 7438
  • E-7438
  • EPZ 6438

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Tumor Response
Tidsram: Up to 6 months

Will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The statistic reported is the response rate (i.e. (total responses / total at risk) * 100).

Up to 6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Tumor Response in Patients With ARID1A Mutations Using Tumor Response (Removed as of Version Date 20-OCT-2021)
Tidsram: Up to 6 months

Will be defined by RECIST v 1.1.

Up to 6 months
6-month Progression Free Survival (Clinical Benefit Rate)
Tidsram: Up to 6 months

Six-month progression free survival (clinical benefit rate). The clinical benefit rate is the total number (or percentage) of patients who had a complete response, or a partial response or who had stable disease for six months or more.

Up to 6 months
Number of Patients With a Grade 3 (or Higher) Adverse Events
Tidsram: Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months).

Will be assessed according to grade of toxicity by organ or organ system. This will be reported by group (Endometrial or Ovarian). This study reported adverse events by CTCAE v5.0.

Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months).
Progression-free Survival
Tidsram: Progression-free survival times were collected for a maximum of 30.0 months (interquartile range: 1.8 months, 5.5 months).

Will be characterized by quartiles and the median of the distribution with confidence intervals. Kaplan-Meier plots will show an estimate of the survival function for these populations.

Progression-free survival times were collected for a maximum of 30.0 months (interquartile range: 1.8 months, 5.5 months).
Overall Survival
Tidsram: Overall survival times were collected for a maximum of 51.6 months (interquartile range: 4.3 months, 19.0 months).

Will be characterized by quartiles and the median of the distribution with confidence intervals. Kaplan-Meier plots will show an estimate of the survival function for these populations.

Overall survival times were collected for a maximum of 51.6 months (interquartile range: 4.3 months, 19.0 months).

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
ARID1A Mutational Status
Tidsram: Up to 6 months

ARID1A mutational status was ealuated by MSK-IMPACT.

Up to 6 months
BAF250a Expression
Tidsram: Up to 6 months

BAF250a expression was assessed by immunohistochemistry (IHC) as an indicator of ARID1A mutation status.

Up to 6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Samarbetspartners

Utredare

  • Huvudutredare: Ramez N Eskander, NRG Oncology

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 maj 2019

Primärt slutförande (Faktisk)

28 juli 2023

Avslutad studie (Beräknad)

12 februari 2027

Studieregistreringsdatum

Först inskickad

20 november 2017

Först inskickad som uppfyllde QC-kriterierna

20 november 2017

Första postat (Faktisk)

21 november 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

26 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 oktober 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • NCI-2017-02147
  • U10CA180868 (U.S.S. NIH-anslag/kontrakt)
  • NCI-2017-02147 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
  • NRG-GY014 (Annan identifierare: CTEP)
  • NRG-GY014 (Annan identifierare: NRG Oncology)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .