- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05611931
P53 야생형, 진행성 또는 재발성 자궁내막암 참가자를 위한 전신 요법 후 유지 요법에서의 Selinexor (XPORT-EC-042)
P53 야생형, 진행성 또는 재발성 자궁내막암 환자를 위한 전신 요법 후 유지 요법에서 Selinexor의 3상, 무작위, 위약 대조, 이중맹검, 다기관 시험
The purpose of this study is to evaluate the efficacy and safety of selinexor as a maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have achieved a partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v 1.1]) after completing at least 12 weeks of platinum-based therapy. A total of 276 participants will be enrolled in the study and randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo.
연구 개요
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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-
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Batumi, 그루지야, 6000
- High Technology Hospital Medcenter
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Tbilisi, 그루지야, 0114
- LTD New Hospitals
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Tbilisi, 그루지야, 0186
- Caucasus Medical Centre
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Tbilisi, 그루지야, 0112
- Todua Clinic
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Tbilisi, 그루지야, 0156
- Tbilisi Cancer Center
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Tbilisi, 그루지야, 0159
- JSC - K.Eristavi National Center of Experimental and Clinical Surgery
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Tbilisi, 그루지야, 0186
- LTD Innova Medical Center
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Tbilisi, 그루지야, 0186
- Multiprofile Clinic "Consilium Medulla"
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Athens, 그리스, 15123
- Hygeia Hospital
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Athens, 그리스, 11528
- Alexandra Hospital
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Thessaloniki, 그리스, 54645
- Euromedica General Clinic
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Kaohsiung City, 대만, 833401
- Kaohsiung Chang Gung Memorial Hospital
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Taichung, 대만, 407219
- TaiChung Veterans General Hospital
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Tainan, 대만, 71004
- Chi Mei Medical Center
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Taipei, 대만, 104217
- Mackay Memorial Hospital
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Taipei, 대만, 23561
- Taipei Medical University- Shuang Ho Hospital, Ministry of Health and Welfare
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Taoyuan City, 대만, 333
- Chang Gung Memorial Hospital
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-
-
-
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Seongnam-si, 대한민국, 59
- CHA University/Bundang CHA General Hospital
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Seoul, 대한민국, 03080
- Seoul National University Hospital
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Seoul, 대한민국, 73
- Korea University Anam Hospital
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-
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Berlin, 독일, 13353
- Charite Berlin Universitatsmedizin
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Hamburg, 독일, 20246
- Universitätsklinikum Hamburg Eppendorf
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Kiel, 독일, 24105
- Universitatsklinikum Schleswig-Holstein
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Kiel, 독일, 01307
- University Hospital Dresden
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Krefeld, 독일, 47805
- Helios Klinikum Krefeld
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Leipzig, 독일, 04103
- Universitätsklinik Leipzig
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Mainz, 독일, 55131
- Universitätsfrauenklinik Mainz
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Mannheim, 독일, 68167
- Universitätsmedizin Mannheim
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Munich, 독일, 80337
- Klinik und Poliklinik fur Frauenheilkunde und Geburtshilfe GroBhadern
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Rostock, 독일, 18059
- Klinikum Südstadt Rostock
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Ulm, 독일, 89075
- Universitätsfrauenklinik Ulm
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Alabama
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Birmingham, Alabama, 미국, 35205
- The University of Alabama at Birmingham
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Arizona
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Phoenix, Arizona, 미국, 85016
- Honor Health
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Arkansas
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Little Rock, Arkansas, 미국, 72205
- University of Arkansas for Medical Sciences
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California
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Davis, California, 미국, 95616
- UC DAVIS
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Duarte, California, 미국, 91010
- City of Hope National Medical Center
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Irvine, California, 미국, 92618
- City of Hope at Irvine Lennar
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Los Alamitos, California, 미국, 90720
- Cancer and Blood Specialty Clinic
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Los Angeles, California, 미국, 90806
- Long Beach Memorial Medical Center
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Los Angeles, California, 미국, 90095
- UCLA - Women's Health Clinical Research Unit
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Palo Alto, California, 미국, 94304
- Stanford University
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San Francisco, California, 미국, 94109
- California Pacific Medical Center
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Florida
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Fort Lauderdale, Florida, 미국, 33316
- Broward Health Medical Center
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Miami Beach, Florida, 미국, 33140
- Mount Sinai Comprehensive Cancer Center
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Orlando, Florida, 미국, 32804
- Advent Health
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Georgia
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Atlanta, Georgia, 미국, 30322
- Emory University
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Atlanta, Georgia, 미국, 30303
- Grady Hospital
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Augusta, Georgia, 미국, 30912
- Georgia Cancer Center at Augusta University
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Illinois
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Arlington Heights, Illinois, 미국, 60005
- Illinois Cancer Specialists
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Evanston, Illinois, 미국, 60201
- NorthShore University Health System
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Indiana
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Dyer, Indiana, 미국, 46311
- Northwest Cancer Center
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Goshen, Indiana, 미국, 46526
- Goshen Health
-
Indianapolis, Indiana, 미국, 46260
- St Vincent Hospital
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-
Iowa
-
Iowa City, Iowa, 미국, 52242
- University of Iowa
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Louisiana
-
New Orleans, Louisiana, 미국, 70119
- LSU Health Sciences Center New Orleans
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-
Massachusetts
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Boston, Massachusetts, 미국, 02111
- Tufts Medical Center
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Michigan
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Detroit, Michigan, 미국, 48201
- Karmanos Cancer Institute
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Minnesota
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Minneapolis, Minnesota, 미국, 55455
- University of Minnesota
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Minneapolis, Minnesota, 미국, 55404
- USON - Minnesota Oncology Hematology
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Mississippi
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Jackson, Mississippi, 미국, 39216
- St. Dominic's Gynecologic Oncology
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-
Missouri
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Kansas City, Missouri, 미국, 64132
- Midwest Ventures Group HCA MId America Division
-
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Montana
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Billings, Montana, 미국, 59101
- Intermountain Health St. Vincent Regional Hospital
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Nevada
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Reno, Nevada, 미국, 89511
- Center Of Hope
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New York
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Albany, New York, 미국, 12208
- Women's Cancer Care Associates, LLC
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Mineola, New York, 미국, 11501
- NYU Langone Hospital-Long Island
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New Hyde Park, New York, 미국, 11042
- Northwell Health - Zuckerberg Cancer Center
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New York, New York, 미국, 10075
- Lenox Hill Hospital
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New York, New York, 미국, 10016
- Perlmutter Cancer Center at NYU Langone Health
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Rego Park, New York, 미국, 11374
- Northwell Health - Queens Cancer Center
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Rochester, New York, 미국, 14642
- University of Rochester
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North Carolina
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Charlotte, North Carolina, 미국, 28209
- Atrium Health Levine Cancer Institute
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Durham, North Carolina, 미국, 27710
- Duke Cancer Center
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Ohio
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Cleveland, Ohio, 미국, 44109
- MetroHealth
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Columbus, Ohio, 미국, 43219
- Zangmeister Cancer Center
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Sylvania, Ohio, 미국, 43560
- ProMedica Flower Hospital
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73104
- University of Oklahoma Health Sciences Center
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Tulsa, Oklahoma, 미국, 74146
- Oklahoma Cancer Specialists and Research Institute, LLC
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Oregon
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Eugene, Oregon, 미국, 97401
- Oncology Associates of Oregon
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Portland, Oregon, 미국, 97213
- Providence Portland Medical Center
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Pennsylvania
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Langhorne, Pennsylvania, 미국, 19047
- Alliance Cancer Specialists
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Pittsburgh, Pennsylvania, 미국, 15213
- Magee - Women's Hospital
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Pittsburgh, Pennsylvania, 미국, 15224
- Allegheny Health Network - West Penn Hospital
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South Dakota
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Sioux Falls, South Dakota, 미국, 57105
- Avera
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Tennessee
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Knoxville, Tennessee, 미국, 37920
- University of Tennessee Medical Center
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Memphis, Tennessee, 미국, 38103
- University of Tennessee Health Science Center
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Texas
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Austin, Texas, 미국, 78731
- USON - Texas Oncology, Austin Central
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Dallas, Texas, 미국, 75390
- University of Texas Southwestern Medical Center
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Dallas, Texas, 미국, 75235
- Parkland Health & Hospital System
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Dallas, Texas, 미국, 75246
- Texas Oncology - Dallas
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Houston, Texas, 미국, 77030
- Houston Methodist
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San Antonio, Texas, 미국, 78240
- Texas Oncology - San Antonio
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The Woodlands, Texas, 미국, 77380
- Texas Oncology - The Woodlands
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Tyler, Texas, 미국, 75702
- Texas Oncology, PC, Tyler
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Utah
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Salt Lake City, Utah, 미국, 84112
- University of Utah
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Virginia
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Charlottesville, Virginia, 미국, 22908
- University of Virginia
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Wisconsin
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Madison, Wisconsin, 미국, 53792
- University of Wisconsin Hospital and Clinics
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Brussels, 벨기에, 1200
- Cliniques Universitaires St. Luc
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Ghent, 벨기에, 9000
- AZ Sint Lucas
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Leuven, 벨기에, 3000
- UZ Leuven
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Mons, 벨기에, 7000
- CHU Ambroise Pare
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Namur, 벨기에, 5000
- CHU UCL Namur, Site Sainte-Elisabeth
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Badalona, 스페인, 08916
- ICO Badalona
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Barcelona, 스페인, 08036
- Hospital Clinic de Barcelona
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Barcelona, 스페인, 08908
- Institut Catala d'Oncologia Hospitalet
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Barcelona, 스페인, 08035
- Hospital Universitari Vall d' Hebrón
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Córdoba, 스페인, 14004
- Hospital Universitario Reina Sofía
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Girona, 스페인, 17007
- Institut Catala d'Oncologia de Girona
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Granada, 스페인, 18014
- Hospital Universitario Virgen de las Nieves
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Madrid, 스페인, 28046
- Hospital Universitario La Paz
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Madrid, 스페인, 28040
- Hospital Universitario Clinico San Carlos
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Madrid, 스페인, 28033
- MD Anderson Cancer Center Madrid
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Madrid, 스페인, 28041
- H 12 de Octubre
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Madrid, 스페인, 28034
- Hospital Universitario Ramón y Cajal
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Murcia, 스페인, 30120
- Virgen de la Arrixaca University Clinical Hospital
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Málaga, 스페인, 29010
- Hospital Universitatrio Virgen de la Victoria
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Seville, 스페인, 41013
- Hospital Universitario Virgen del Rocío
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Valencia, 스페인, 46026
- Hospital LaFe Uacenlia
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Valencia, 스페인, 46009
- Instituto Valenciano de Oncología
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Valencia, 스페인, 46010
- Hospital Clínico Universitario de Valencia
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Zaragoza, 스페인, 50009
- Hospital Miguel Servet
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Gipuzkoa
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Donostia / San Sebastian, Gipuzkoa, 스페인, 20014
- Hospital Universitario Donostia
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Zaragoza
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Zaragoza, Zaragoza, 스페인, 50009
- Hospital Clínico Universitario Lozano Blesa
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-
-
-
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Bratislava, 슬로바키아, 83310
- National Cancer Institute
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Bratislava, 슬로바키아, 81250
- St. Elisabeth Cancer Institute
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Bratislava, 슬로바키아, 82606
- UH Bratislava
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Trenčín, 슬로바키아, 91101
- UH Trenčín
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-
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-
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Cork, 아일랜드, T12 DC4A
- Cork University Hospital
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Dublin, 아일랜드, D08 NHY1
- St. James Hospital
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Galway, 아일랜드, H91 YR71
- Galway University
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Waterford, 아일랜드, X91 ER8E
- University Hospital Waterford
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Elm Park
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Dublin, Elm Park, 아일랜드, D04 T6F4
- St. Vincent's University Hospital
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-
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Hadera, 이스라엘, 38100
- Hillel-Yaffe Medical Center
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Holon, 이스라엘
- Wolfson Medical Center
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Jerusalem, 이스라엘, 91120
- Hadassah Medical Center
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Ramat Gan, 이스라엘, 52621
- Sheba Medical Center
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-
-
-
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Bologna, 이탈리아, 40138
- IRCCS Azienda Ospedaliero Universitaria di Bologna
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Brescia, 이탈리아, 25123
- ASST Spedali Civili Di Brescia
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Meldola, 이탈리아, 47014
- IRCCS Istituto Romagnolo Per Lo Studio Del Tumori "Dino Amadori" - IRST S.R.L.
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Milan, 이탈리아, 20141
- Instituto Europeo di Oncologia
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Milan, 이탈리아, 20133
- Istituto Nazionale dei Tumori IRCCS - MILANO S. C. Ginecologia Oncologica
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Milan, 이탈리아, 20159
- Humanitas San Pio X Hospital
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Milan, 이탈리아, 20132
- San Raffaele Hospital
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Monza, 이탈리아, 20900
- Ospedale San Gerardo - Asst Monza
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Naples, 이탈리아, 20133
- "Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" - NAPOLI Struttura Complessa Oncologia Medica Uro-Ginecologica"
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Padova, 이탈리아, 35128
- Istituto Oncologico Veneto
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Pisa, 이탈리아, 56127
- Universita di Pisa
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Prato, 이탈리아, 59100
- Nuovo Ospedale di Prato
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Roma, 이탈리아, 00168
- Fondazione Policlinico Universitario Agostino Gemelli - ROMA
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Torino, 이탈리아, 10128
- AO Ordine Mauriziano
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Torino, 이탈리아, 10124
- Ospedale Ostetrico Ginecologico Sant'Anna
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-
-
-
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Brno, 체코, 60200
- University Hospital Brno
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Ostrava, 체코, 70852
- University Hospital Ostrava
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Prague, 체코, 10034
- UH Královské Vinohrady
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Prague, 체코, 12851
- General University Hospital in Prague
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Prague, 체코, 18100
- Hospital Na Bulovce
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-
-
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Alberta
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Edmonton, Alberta, 캐나다, T6G 1Z2
- Cross Cancer Institute
-
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Ontario
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Toronto, Ontario, 캐나다, M5G 2M9
- Princess Margaret
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Toronto, Ontario, 캐나다, M9L 2H9
- Sunnybrook Research Institute
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Quebec
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Montreal, Quebec, 캐나다, H2X 0C1
- Centre Hospitalier de l'Université de Montréal
-
Montreal, Quebec, 캐나다
- Hospital Maisonneuve-Rosemont
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Montreal, Quebec, 캐나다, H4A3J1
- McGill University Health Centre (MUHC)
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-
-
-
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Adana, 터키 (Türkiye), 34920
- Adana Baskent Hospital
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Adana, 터키 (Türkiye), 01330
- Çukurova University
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Ankara, 터키 (Türkiye), 06520
- Memorial Ankara Hospital
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Ankara, 터키 (Türkiye), 06230
- Hacettepe University Oncology Hospital
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Istanbul, 터키 (Türkiye), 34303
- Acibadem Atakent Hospital
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Istanbul, 터키 (Türkiye), 34098
- Cerrahpasa University
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Ankara
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Çankaya, Ankara, 터키 (Türkiye), 34093
- Ankara Baskent Hospital
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-
-
-
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Debrecen, 헝가리, 4032
- Unit of Gynecol.Oncol., Dept.Obstet.Gynecol., Clinical Center, University of Debrecen
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Győr, 헝가리, 9024
- Petz Aladár University Teaching Hospital
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-
-
-
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Southport, 호주, 5000
- The Royal Adelaide Hospital
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New South Wales
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Albury, New South Wales, 호주, 2640
- Border Medical Oncology & Haematology
-
Campbelltown, New South Wales, 호주, 2560
- Macarthur Cancer Therapy Centre
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Camperdown, New South Wales, 호주, 2050
- Chris O'Brien Lifehouse
-
Gosford, New South Wales, 호주, 2250
- Central Coast LHD - Gosford & Wyong Hospitals
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New Lambton Heights, New South Wales, 호주, 2305
- Newcastle Private Hospital
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Saint Leonards, New South Wales, 호주
- Royal North Shore Hospital
-
Wentworthville, New South Wales, 호주, 2145
- Westmead Hospital
-
-
Queensland
-
Southport, Queensland, 호주, 4215
- ICON Cancer Centre Southport
-
Toowoomba, Queensland, 호주, 4350
- Toowoomba Hospital
-
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Tasmania
-
Hobart, Tasmania, 호주, 7000
- Royal Hobart Hospital
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-
Victoria
-
Box Hill, Victoria, 호주, 3128
- Box Hill Hospital - Eastern Health (Oncology)
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Clayton, Victoria, 호주, 3168
- Monash Health
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Frankston, Victoria, 호주, 3199
- Frankston Hospital
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Malvern, Victoria, 호주, 3144
- Cabrini Health
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria: Patients must meet all of the following inclusion criteria in order to be eligible to participate in this study:
- Adults (Aged ≥ 18 years)
- Histologically confirmed endometrial cancer (endometrioid, serous, undifferentiated, or carcinosarcoma sub-types) that is TP53 wild type by central NGS
- Must have completed at least 12 weeks of platinum-based chemotherapy (with or without immune checkpoint inhibitors), with a confirmed partial or complete response according to RECIST v1.1
- Must be able to initiate C1D1 within 3-8 weeks after last platinum dose
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate bone marrow function and organ function
Exclusion Criteria: Patients meeting any of the following exclusion criteria are not eligible to participate in this study:
- Uterine sarcomas, clear cell or small cell carcinoma with neuroendocrine differentiation
- Palliative radiotherapy administered within 14 days of intended C1D1
- Any gastrointestinal dysfunction that could interfere with the absorption of oral study therapy
- Serious psychiatric or medical conditions that could interfere with study participation or would make study involvement unreasonably hazardous
- Previous treatment with an XPO1 inhibitor
- Stable disease or disease progression after platinum-based chemotherapy
- Pregnancy, breastfeeding, or other legal/ethical restrictions to trial participation
- Known dMMR/MSI-H EC tumors that are medically eligible to receive an immune checkpoint inhibitor
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Selinexor
Participants will receive a fixed dose of selinexor 60 milligrams (mg) oral tablets once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle. |
Dose: 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral
다른 이름들:
|
|
위약 비교기: Placebo
Participants will receive matching placebo for selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle. |
Dose:60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
조사관은 Recist v1.1에 따라 진행 자유 생존 (PFS)을 평가했습니다
기간: 무작위 배정에서 질병 진행 (PD) 또는 사망에 이르기까지 첫 번째 (최대 34 개월)
|
무작위 배정에서 질병 진행 (PD) 또는 사망에 이르기까지 첫 번째 (최대 34 개월)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
맹인 독립 중앙 검토 (BICR)에 의해 평가 된 무 진행 생존 (PFS), Recist v1.1에 따라
기간: 무작위 배정에서 질병 진행 (PD) 또는 사망에 이르기까지 첫 번째 (최대 34 개월)
|
무작위 배정에서 질병 진행 (PD) 또는 사망에 이르기까지 첫 번째 (최대 34 개월)
|
|
|
Overall Survival (OS)
기간: Up to 34 months
|
Time from randomization to death due to any cause |
Up to 34 months
|
|
Safety and tolerability of study drug (selinexor and placebo)
기간: From start of study drug administration up to 34 months
|
The safety and tolerability of study drug (selinexor and placebo) will be evaluated based on adverse event (AE) reports, physical examination results (including vital signs), and clinical laboratory results, by means of the occurrence, nature, and severity of AEs via Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0. |
From start of study drug administration up to 34 months
|
|
Time to First Subsequent Therapy (TFST)
기간: From randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months)
|
Time from randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first |
From randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months)
|
|
Time to Second Subsequent Therapy (TSST)
기간: From randomization until date of initiation of second therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months)
|
Time from randomization until date of initiation of second therapy after discontinuation of study drug or death, whichever occurs first |
From randomization until date of initiation of second therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months)
|
|
Progression-free survival after initiating a next-line treatment (PFS2)
기간: From randomization until the next-line progression event or death due to any cause, up to 34 months
|
Time from randomization until the progression event after initiating a next-line treatment or death due to any cause, whichever occurs first |
From randomization until the next-line progression event or death due to any cause, up to 34 months
|
|
EuroQol-5 Dimensions-5 Levels Quality of Life Questionnaire (EQ-5D-5L)
기간: From baseline and at specified timepoints up to 34 months
|
EQ-5D-5L is a generic questionnaire that assesses health status as perceived by the patient across 5 categories (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and overall. |
From baseline and at specified timepoints up to 34 months
|
공동 작업자 및 조사자
협력자
간행물 및 유용한 링크
일반 간행물
- Makker V, Perez-Fidalgo JA, Valabrega G, Hamilton E, Van Gorp T, Sehouli J, Reginacova K, Richardson DL, Perri T, Oza AM, Miller DS, Alia EMG, De Giorgi U, Henry S, Spitz DL, Wimberger P, Bednarikova M, Chon HS, Martinez-Garcia J, Pisano C, Berek JS, Romero I, Scambia G, Farinas-Madrid L, Buscema J, Schochter F, Li K, Kalyanapu P, Walker CJ, Vergote I. Long-term follow-up of efficacy and safety of selinexor maintenance treatment in patients with TP53wt advanced or recurrent endometrial cancer: A subgroup analysis of the ENGOT-EN5/GOG-3055/SIENDO study. Gynecol Oncol. 2024 Jun;185:202-211. doi: 10.1016/j.ygyno.2024.05.016. Epub 2024 Jun 3.
- Vergote I, Perez Fidalgo A, Valabrega G, Monk BJ, Herzog T, Cibula D, Colombo N, Pothuri B, Sehouli J, Korach J, Barlin J, Papadimitriou CA, van Gorp T, Richardson D, McCarthy M, Antill Y, Mirza MR, Li K, Kalyanapu P, Slomovitz B, Coleman RL. ENGOT-EN20/GOG-3083/XPORT-EC-042 - A phase III, randomized, placebo-controlled, double-blind, multicenter trial of selinexor in maintenance therapy after systemic therapy for patients with p53 wild-type, advanced, or recurrent endometrial carcinoma: rationale, methods, and trial design. Int J Gynecol Cancer. 2024 Aug 5;34(8):1283-1289. doi: 10.1136/ijgc-2024-005412.
- Secord AA, Powell MA, McAlpine J. Molecular Characterization and Clinical Implications of Endometrial Cancer. Obstet Gynecol. 2025 Nov 1;146(5):660-671. doi: 10.1097/AOG.0000000000006080. Epub 2025 Sep 18.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- XPORT-EC-042
- GOG-3083 (기타 식별자: The GOG Foundation, Inc.)
- ENGOT-EN20 (기타 식별자: European Network of Gynaecological Oncological Trial)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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