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Tazemetostat ved behandling av pasienter med tilbakevendende ovarie- eller endometriekreft

23. oktober 2026 oppdatert av: National Cancer Institute (NCI)

En fase II-studie av Tazemetostat (EPZ-6438) (IND # 138671) ved tilbakevendende eller vedvarende endometrioid eller klarcellet karsinom i eggstokken, og tilbakevendende eller vedvarende endometrioid endometrieadenokarsinom

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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

62

Fase

  • Fase 2

Kontakter og plasseringer

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Fremgangsmåte: Magnetic Resonance Imaging

Undergo MRI

Andre navn:
  • MR
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medisinsk bildebehandling, magnetisk resonans / kjernemagnetisk resonans
  • MR Imaging
  • MR-skanning
  • NMR-avbildning
  • NMRI
  • Kjernemagnetisk resonansavbildning
  • Magnetisk resonanstomografi (MR)
  • sMRI
  • Magnetisk resonansavbildning (prosedyre)
  • MR-er
  • Strukturell MR
Fremgangsmåte: Computed Tomography

Undergo CT scan

Andre navn:
  • CT
  • KATT
  • CAT-skanning
  • Beregnet aksial tomografi
  • Datastyrt aksialtomografi
  • Datastyrt tomografi
  • CT skann
  • tomografi
  • Datastyrt aksial tomografi (prosedyre)
  • Datastyrt tomografi (CT) skanning
  • Diagnostisk CAT -skanning
  • Diagnostisk CAT -skannertype
Legemiddel: Tazemetostat

Given PO

Andre navn:
  • EPZ-6438
  • E7438
  • EPZ6438
  • E 7438
  • E-7438
  • EPZ 6438

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Tumor Response
Tidsramme: 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

Sekundære resultatmål

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

Will be defined by RECIST v 1.1.
Up to 6 months
6-month Progression Free Survival (Clinical Benefit Rate)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
ARID1A Mutational Status
Tidsramme: Up to 6 months

ARID1A mutational status was ealuated by MSK-IMPACT.
Up to 6 months
BAF250a Expression
Tidsramme: Up to 6 months

BAF250a expression was assessed by immunohistochemistry (IHC) as an indicator of ARID1A mutation status.
Up to 6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Cancer Institute (NCI)

Samarbeidspartnere

NRG Oncology

Etterforskere

  • Hovedetterforsker: Ramez N Eskander, NRG Oncology

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2019

Primær fullføring (Faktiske)

28. juli 2023

Studiet fullført (Antatt)

12. februar 2027

Datoer for studieregistrering

Først innsendt

20. november 2017

Først innsendt som oppfylte QC-kriteriene

20. november 2017

Først lagt ut (Faktiske)

21. november 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. oktober 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NCI-2017-02147
  • U10CA180868 (U.S. NIH-stipend/kontrakt)
  • NCI-2017-02147 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
  • NRG-GY014 (Annen identifikator: CTEP)
  • NRG-GY014 (Annen identifikator: NRG Oncology)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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