Selinexor i vedligeholdelsesterapi efter systemisk terapi for deltagere med p53 vildtype, avanceret eller tilbagevendende endometriekarcinom (XPORT-EC-042)
28. oktober 2026 opdateret af: Karyopharm Therapeutics Inc
Et fase 3, randomiseret, placebokontrolleret, dobbeltblindet, multicenterforsøg med Selinexor i vedligeholdelsesterapi efter systemisk terapi til patienter med p53 vildtype, avanceret eller tilbagevendende endometriekarcinom
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.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
257
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Southport, Australien, 5000
- The Royal Adelaide Hospital
-
-
New South Wales
-
Albury, New South Wales, Australien, 2640
- Border Medical Oncology & Haematology
-
Campbelltown, New South Wales, Australien, 2560
- Macarthur Cancer Therapy Centre
-
Camperdown, New South Wales, Australien, 2050
- Chris O'Brien Lifehouse
-
Gosford, New South Wales, Australien, 2250
- Central Coast LHD - Gosford & Wyong Hospitals
-
New Lambton Heights, New South Wales, Australien, 2305
- Newcastle Private Hospital
-
Saint Leonards, New South Wales, Australien
- Royal North Shore Hospital
-
Wentworthville, New South Wales, Australien, 2145
- Westmead Hospital
-
-
Queensland
-
Southport, Queensland, Australien, 4215
- ICON Cancer Centre Southport
-
Toowoomba, Queensland, Australien, 4350
- Toowoomba Hospital
-
-
Tasmania
-
Hobart, Tasmania, Australien, 7000
- Royal Hobart Hospital
-
-
Victoria
-
Box Hill, Victoria, Australien, 3128
- Box Hill Hospital - Eastern Health (Oncology)
-
Clayton, Victoria, Australien, 3168
- Monash Health
-
Frankston, Victoria, Australien, 3199
- Frankston Hospital
-
Malvern, Victoria, Australien, 3144
- Cabrini Health
-
-
-
-
-
Brussels, Belgien, 1200
- Cliniques Universitaires St. Luc
-
Ghent, Belgien, 9000
- AZ Sint Lucas
-
Leuven, Belgien, 3000
- UZ Leuven
-
Mons, Belgien, 7000
- CHU Ambroise Pare
-
Namur, Belgien, 5000
- CHU UCL Namur, Site Sainte-Elisabeth
-
-
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret
-
Toronto, Ontario, Canada, M9L 2H9
- Sunnybrook Research Institute
-
-
Quebec
-
Montreal, Quebec, Canada, H2X 0C1
- Centre Hospitalier de l'Université de Montréal
-
Montreal, Quebec, Canada
- Hospital Maisonneuve-Rosemont
-
Montreal, Quebec, Canada, H4A3J1
- McGill University Health Centre (MUHC)
-
-
-
-
Alabama
-
Birmingham, Alabama, Forenede Stater, 35205
- The University of Alabama at Birmingham
-
-
Arizona
-
Phoenix, Arizona, Forenede Stater, 85016
- Honor Health
-
-
Arkansas
-
Little Rock, Arkansas, Forenede Stater, 72205
- University of Arkansas for Medical Sciences
-
-
California
-
Davis, California, Forenede Stater, 95616
- UC DAVIS
-
Duarte, California, Forenede Stater, 91010
- City of Hope National Medical Center
-
Irvine, California, Forenede Stater, 92618
- City of Hope at Irvine Lennar
-
Los Alamitos, California, Forenede Stater, 90720
- Cancer and Blood Specialty Clinic
-
Los Angeles, California, Forenede Stater, 90806
- Long Beach Memorial Medical Center
-
Los Angeles, California, Forenede Stater, 90095
- UCLA - Women's Health Clinical Research Unit
-
Palo Alto, California, Forenede Stater, 94304
- Stanford University
-
San Francisco, California, Forenede Stater, 94109
- California Pacific Medical Center
-
-
Florida
-
Fort Lauderdale, Florida, Forenede Stater, 33316
- Broward Health Medical Center
-
Miami Beach, Florida, Forenede Stater, 33140
- Mount Sinai Comprehensive Cancer Center
-
Orlando, Florida, Forenede Stater, 32804
- Advent Health
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30322
- Emory University
-
Atlanta, Georgia, Forenede Stater, 30303
- Grady Hospital
-
Augusta, Georgia, Forenede Stater, 30912
- Georgia Cancer Center at Augusta University
-
-
Illinois
-
Arlington Heights, Illinois, Forenede Stater, 60005
- Illinois Cancer Specialists
-
Evanston, Illinois, Forenede Stater, 60201
- NorthShore University Health System
-
-
Indiana
-
Dyer, Indiana, Forenede Stater, 46311
- Northwest Cancer Center
-
Goshen, Indiana, Forenede Stater, 46526
- Goshen Health
-
Indianapolis, Indiana, Forenede Stater, 46260
- St Vincent Hospital
-
-
Iowa
-
Iowa City, Iowa, Forenede Stater, 52242
- University of Iowa
-
-
Louisiana
-
New Orleans, Louisiana, Forenede Stater, 70119
- LSU Health Sciences Center New Orleans
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02111
- Tufts Medical Center
-
-
Michigan
-
Detroit, Michigan, Forenede Stater, 48201
- Karmanos Cancer Institute
-
-
Minnesota
-
Minneapolis, Minnesota, Forenede Stater, 55455
- University of Minnesota
-
Minneapolis, Minnesota, Forenede Stater, 55404
- USON - Minnesota Oncology Hematology
-
-
Mississippi
-
Jackson, Mississippi, Forenede Stater, 39216
- St. Dominic's Gynecologic Oncology
-
-
Missouri
-
Kansas City, Missouri, Forenede Stater, 64132
- Midwest Ventures Group HCA MId America Division
-
-
Montana
-
Billings, Montana, Forenede Stater, 59101
- Intermountain Health St. Vincent Regional Hospital
-
-
Nevada
-
Reno, Nevada, Forenede Stater, 89511
- Center Of Hope
-
-
New York
-
Albany, New York, Forenede Stater, 12208
- Women's Cancer Care Associates, LLC
-
Mineola, New York, Forenede Stater, 11501
- NYU Langone Hospital-Long Island
-
New Hyde Park, New York, Forenede Stater, 11042
- Northwell Health - Zuckerberg Cancer Center
-
New York, New York, Forenede Stater, 10075
- Lenox Hill Hospital
-
New York, New York, Forenede Stater, 10016
- Perlmutter Cancer Center at NYU Langone Health
-
Rego Park, New York, Forenede Stater, 11374
- Northwell Health - Queens Cancer Center
-
Rochester, New York, Forenede Stater, 14642
- University of Rochester
-
-
North Carolina
-
Charlotte, North Carolina, Forenede Stater, 28209
- Atrium Health Levine Cancer Institute
-
Durham, North Carolina, Forenede Stater, 27710
- Duke Cancer Center
-
-
Ohio
-
Cleveland, Ohio, Forenede Stater, 44109
- MetroHealth
-
Columbus, Ohio, Forenede Stater, 43219
- Zangmeister Cancer Center
-
Sylvania, Ohio, Forenede Stater, 43560
- ProMedica Flower Hospital
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forenede Stater, 73104
- University of Oklahoma Health Sciences Center
-
Tulsa, Oklahoma, Forenede Stater, 74146
- Oklahoma Cancer Specialists and Research Institute, LLC
-
-
Oregon
-
Eugene, Oregon, Forenede Stater, 97401
- Oncology Associates of Oregon
-
Portland, Oregon, Forenede Stater, 97213
- Providence Portland Medical Center
-
-
Pennsylvania
-
Langhorne, Pennsylvania, Forenede Stater, 19047
- Alliance Cancer Specialists
-
Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Magee - Women's Hospital
-
Pittsburgh, Pennsylvania, Forenede Stater, 15224
- Allegheny Health Network - West Penn Hospital
-
-
South Dakota
-
Sioux Falls, South Dakota, Forenede Stater, 57105
- Avera
-
-
Tennessee
-
Knoxville, Tennessee, Forenede Stater, 37920
- University of Tennessee Medical Center
-
Memphis, Tennessee, Forenede Stater, 38103
- University of Tennessee Health Science Center
-
-
Texas
-
Austin, Texas, Forenede Stater, 78731
- USON - Texas Oncology, Austin Central
-
Dallas, Texas, Forenede Stater, 75390
- University of Texas Southwestern Medical Center
-
Dallas, Texas, Forenede Stater, 75235
- Parkland Health & Hospital System
-
Dallas, Texas, Forenede Stater, 75246
- Texas Oncology - Dallas
-
Houston, Texas, Forenede Stater, 77030
- Houston Methodist
-
San Antonio, Texas, Forenede Stater, 78240
- Texas Oncology - San Antonio
-
The Woodlands, Texas, Forenede Stater, 77380
- Texas Oncology - The Woodlands
-
Tyler, Texas, Forenede Stater, 75702
- Texas Oncology, PC, Tyler
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84112
- University of Utah
-
-
Virginia
-
Charlottesville, Virginia, Forenede Stater, 22908
- University of Virginia
-
-
Wisconsin
-
Madison, Wisconsin, Forenede Stater, 53792
- University of Wisconsin Hospital and Clinics
-
-
-
-
-
Batumi, Georgien, 6000
- High Technology Hospital Medcenter
-
Tbilisi, Georgien, 0114
- LTD New Hospitals
-
Tbilisi, Georgien, 0186
- Caucasus Medical Centre
-
Tbilisi, Georgien, 0112
- Todua Clinic
-
Tbilisi, Georgien, 0156
- Tbilisi Cancer Center
-
Tbilisi, Georgien, 0159
- JSC - K.Eristavi National Center of Experimental and Clinical Surgery
-
Tbilisi, Georgien, 0186
- LTD Innova Medical Center
-
Tbilisi, Georgien, 0186
- Multiprofile Clinic "Consilium Medulla"
-
-
-
-
-
Athens, Grækenland, 15123
- Hygeia Hospital
-
Athens, Grækenland, 11528
- Alexandra Hospital
-
Thessaloniki, Grækenland, 54645
- Euromedica General Clinic
-
-
-
-
-
Cork, Irland, T12 DC4A
- Cork University Hospital
-
Dublin, Irland, D08 NHY1
- St. James Hospital
-
Galway, Irland, H91 YR71
- Galway University
-
Waterford, Irland, X91 ER8E
- University Hospital Waterford
-
-
Elm Park
-
Dublin, Elm Park, Irland, D04 T6F4
- St. Vincent's University Hospital
-
-
-
-
-
Hadera, Israel, 38100
- Hillel-Yaffe Medical Center
-
Holon, Israel
- Wolfson Medical Center
-
Jerusalem, Israel, 91120
- Hadassah Medical Center
-
Ramat Gan, Israel, 52621
- Sheba Medical Center
-
-
-
-
-
Bologna, Italien, 40138
- IRCCS Azienda Ospedaliero Universitaria di Bologna
-
Brescia, Italien, 25123
- ASST Spedali Civili Di Brescia
-
Meldola, Italien, 47014
- IRCCS Istituto Romagnolo Per Lo Studio Del Tumori "Dino Amadori" - IRST S.R.L.
-
Milan, Italien, 20141
- Instituto Europeo di Oncologia
-
Milan, Italien, 20133
- Istituto Nazionale dei Tumori IRCCS - MILANO S. C. Ginecologia Oncologica
-
Milan, Italien, 20159
- Humanitas San Pio X Hospital
-
Milan, Italien, 20132
- San Raffaele Hospital
-
Monza, Italien, 20900
- Ospedale San Gerardo - Asst Monza
-
Naples, Italien, 20133
- "Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" - NAPOLI Struttura Complessa Oncologia Medica Uro-Ginecologica"
-
Padova, Italien, 35128
- Istituto Oncologico Veneto
-
Pisa, Italien, 56127
- Universita di Pisa
-
Prato, Italien, 59100
- Nuovo Ospedale di Prato
-
Roma, Italien, 00168
- Fondazione Policlinico Universitario Agostino Gemelli - ROMA
-
Torino, Italien, 10128
- AO Ordine Mauriziano
-
Torino, Italien, 10124
- Ospedale Ostetrico Ginecologico Sant'Anna
-
-
-
-
-
Bratislava, Slovakiet, 83310
- National Cancer Institute
-
Bratislava, Slovakiet, 81250
- St. Elisabeth Cancer Institute
-
Bratislava, Slovakiet, 82606
- UH Bratislava
-
Trenčín, Slovakiet, 91101
- UH Trenčín
-
-
-
-
-
Badalona, Spanien, 08916
- ICO Badalona
-
Barcelona, Spanien, 08036
- Hospital Clinic de Barcelona
-
Barcelona, Spanien, 08908
- Institut Catala d'Oncologia Hospitalet
-
Barcelona, Spanien, 08035
- Hospital Universitari Vall d' Hebrón
-
Córdoba, Spanien, 14004
- Hospital Universitario Reina Sofía
-
Girona, Spanien, 17007
- Institut Catala d'Oncologia de Girona
-
Granada, Spanien, 18014
- Hospital Universitario Virgen de las Nieves
-
Madrid, Spanien, 28046
- Hospital Universitario La Paz
-
Madrid, Spanien, 28040
- Hospital Universitario Clinico San Carlos
-
Madrid, Spanien, 28033
- MD Anderson Cancer Center Madrid
-
Madrid, Spanien, 28041
- H 12 de Octubre
-
Madrid, Spanien, 28034
- Hospital Universitario Ramón y Cajal
-
Murcia, Spanien, 30120
- Virgen de la Arrixaca University Clinical Hospital
-
Málaga, Spanien, 29010
- Hospital Universitatrio Virgen de la Victoria
-
Seville, Spanien, 41013
- Hospital Universitario Virgen del Rocío
-
Valencia, Spanien, 46026
- Hospital LaFe Uacenlia
-
Valencia, Spanien, 46009
- Instituto Valenciano de Oncología
-
Valencia, Spanien, 46010
- Hospital Clínico Universitario de Valencia
-
Zaragoza, Spanien, 50009
- Hospital Miguel Servet
-
-
Gipuzkoa
-
Donostia / San Sebastian, Gipuzkoa, Spanien, 20014
- Hospital Universitario Donostia
-
-
Zaragoza
-
Zaragoza, Zaragoza, Spanien, 50009
- Hospital Clínico Universitario Lozano Blesa
-
-
-
-
-
Seongnam-si, Sydkorea, 59
- CHA University/Bundang CHA General Hospital
-
Seoul, Sydkorea, 03080
- Seoul National University Hospital
-
Seoul, Sydkorea, 73
- Korea University Anam Hospital
-
-
-
-
-
Kaohsiung City, Taiwan, 833401
- Kaohsiung Chang Gung Memorial Hospital
-
Taichung, Taiwan, 407219
- TaiChung Veterans General Hospital
-
Tainan, Taiwan, 71004
- Chi Mei Medical Center
-
Taipei, Taiwan, 104217
- Mackay Memorial Hospital
-
Taipei, Taiwan, 23561
- Taipei Medical University- Shuang Ho Hospital, Ministry of Health and Welfare
-
Taoyuan City, Taiwan, 333
- Chang Gung Memorial Hospital
-
-
-
-
-
Brno, Tjekkiet, 60200
- University Hospital Brno
-
Ostrava, Tjekkiet, 70852
- University Hospital Ostrava
-
Prague, Tjekkiet, 10034
- UH Královské Vinohrady
-
Prague, Tjekkiet, 12851
- General University Hospital in Prague
-
Prague, Tjekkiet, 18100
- Hospital Na Bulovce
-
-
-
-
-
Adana, Tyrkiet (Türkiye), 34920
- Adana Baskent Hospital
-
Adana, Tyrkiet (Türkiye), 01330
- Çukurova University
-
Ankara, Tyrkiet (Türkiye), 06520
- Memorial Ankara Hospital
-
Ankara, Tyrkiet (Türkiye), 06230
- Hacettepe University Oncology Hospital
-
Istanbul, Tyrkiet (Türkiye), 34303
- Acibadem Atakent Hospital
-
Istanbul, Tyrkiet (Türkiye), 34098
- Cerrahpasa University
-
-
Ankara
-
Çankaya, Ankara, Tyrkiet (Türkiye), 34093
- Ankara Baskent Hospital
-
-
-
-
-
Berlin, Tyskland, 13353
- Charite Berlin Universitatsmedizin
-
Hamburg, Tyskland, 20246
- Universitätsklinikum Hamburg Eppendorf
-
Kiel, Tyskland, 24105
- Universitatsklinikum Schleswig-Holstein
-
Kiel, Tyskland, 01307
- University Hospital Dresden
-
Krefeld, Tyskland, 47805
- Helios Klinikum Krefeld
-
Leipzig, Tyskland, 04103
- Universitätsklinik Leipzig
-
Mainz, Tyskland, 55131
- Universitätsfrauenklinik Mainz
-
Mannheim, Tyskland, 68167
- Universitätsmedizin Mannheim
-
Munich, Tyskland, 80337
- Klinik und Poliklinik fur Frauenheilkunde und Geburtshilfe GroBhadern
-
Rostock, Tyskland, 18059
- Klinikum Südstadt Rostock
-
Ulm, Tyskland, 89075
- Universitätsfrauenklinik Ulm
-
-
-
-
-
Debrecen, Ungarn, 4032
- Unit of Gynecol.Oncol., Dept.Obstet.Gynecol., Clinical Center, University of Debrecen
-
Győr, Ungarn, 9024
- Petz Aladár University Teaching Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
Andre navne:
|
|
Placebo komparator: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Undersøger vurderet Progression Free Survival (PFS) pr. RECIST V1.1
Tidsramme: Fra randomisering til sygdomsprogression (PD) eller død, alt efter hvad der først forekommer (op til 34 måneder)
|
Fra randomisering til sygdomsprogression (PD) eller død, alt efter hvad der først forekommer (op til 34 måneder)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-fri overlevelse (PFS) som vurderet af en blindet uafhængig central gennemgang (BICR) pr. RECIST v1.1
Tidsramme: Fra randomisering til sygdomsprogression (PD) eller død, alt efter hvad der først forekommer (op til 34 måneder)
|
Fra randomisering til sygdomsprogression (PD) eller død, alt efter hvad der først forekommer (op til 34 måneder)
|
|
|
Overall Survival (OS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
18. april 2023
Primær færdiggørelse (Faktiske)
22. maj 2026
Studieafslutning (Anslået)
1. januar 2028
Datoer for studieregistrering
Først indsendt
3. november 2022
Først indsendt, der opfyldte QC-kriterier
3. november 2022
Først opslået (Faktiske)
10. november 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. oktober 2026
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Livmodersygdomme
- Kønssygdomme, kvindelige
- Genitale neoplasmer, kvindelige
- Uterine neoplasmer
- Endometriale neoplasmer
- Selinexor
Andre undersøgelses-id-numre
- XPORT-EC-042
- GOG-3083 (Anden identifikator: The GOG Foundation, Inc.)
- ENGOT-EN20 (Anden identifikator: European Network of Gynaecological Oncological Trial)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ja
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .