NCT05611931

Brief Summary

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.

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
276

participants targeted

Target at P50-P75 for phase_3

Timeline
20mo left

Started Apr 2023

Longer than P75 for phase_3

Geographic Reach
17 countries

217 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Apr 2023Jan 2028

First Submitted

Initial submission to the registry

November 3, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 10, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

April 18, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

November 3, 2022

Last Update Submit

April 22, 2026

Conditions

Keywords

SelinexorKPT-330Advanced or Recurrent Endometrial CarcinomaXPORT-ECENGOT-EN20GOG-3083XPORT-EC-042p53 wild-typeTumor protein 53 wild-type

Outcome Measures

Primary Outcomes (1)

  • Investigator assessed Progression Free Survival (PFS) per RECIST v1.1

    From randomization until disease progression (PD) or death, whichever occurs first (up to 34 months)

Secondary Outcomes (7)

  • Overall Survival (OS)

    Up to 34 months

  • Safety and tolerability of study drug (selinexor and placebo)

    From start of study drug administration up to 34 months

  • Time to First Subsequent Therapy (TFST)

    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)

    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)

    From randomization until the next-line progression event or death due to any cause, up to 34 months

  • +2 more secondary outcomes

Study Arms (2)

Selinexor

EXPERIMENTAL

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.

Drug: Selinexor

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo for selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle.

Drug: Matching Placebo for selinexor

Interventions

Dose: 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral

Also known as: KPT-330
Selinexor

Dose:60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral

Placebo

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (Aged ≥ 18 years)
  • Histologically confirmed endometrial cancer (endometrioid, serous, undifferentiated, or carcinosarcoma sub-types) that is TP53 wild type by central NGSHistologically confirmed EC including endometrioid, serous, undifferentiated, and carcinosarcoma
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (217)

The University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

RECRUITING

Honor Health

Phoenix, Arizona, 85016, United States

RECRUITING

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

UC DAVIS

Davis, California, 95616, United States

RECRUITING

City of Hope National Medical Center

Duarte, California, 91010, United States

RECRUITING

Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, 92612, United States

WITHDRAWN

City of Hope at Irvine Lennar

Irvine, California, 92618, United States

RECRUITING

Cancer and Blood Specialty Clinic

Los Alamitos, California, 90720, United States

RECRUITING

UCLA - Women's Health Clinical Research Unit

Los Angeles, California, 90095, United States

RECRUITING

Long Beach Memorial Medical Center

Los Angeles, California, 90806, United States

RECRUITING

UC Irvine

Orange, California, 92868, United States

WITHDRAWN

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

California Pacific Medical Center

San Francisco, California, 94109, United States

RECRUITING

Highlands Ranch Hospital

Highlands Ranch, Colorado, 80129, United States

WITHDRAWN

University of Colorado Cancer Center

Highlands Ranch, Colorado, 80129, United States

WITHDRAWN

Broward Health Medical Center

Fort Lauderdale, Florida, 33316, United States

RECRUITING

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

RECRUITING

Advent Health

Orlando, Florida, 32804, United States

RECRUITING

Grady Hospital

Atlanta, Georgia, 30303, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Georgia Cancer Center at Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

RECRUITING

Illinois Cancer Specialists

Arlington Heights, Illinois, 60005, United States

RECRUITING

NorthShore University Health System

Evanston, Illinois, 60201, United States

RECRUITING

Northwest Cancer Center

Dyer, Indiana, 46311, United States

RECRUITING

Goshen Health

Goshen, Indiana, 46526, United States

RECRUITING

St Vincent Hospital

Indianapolis, Indiana, 46260, United States

RECRUITING

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

Our Lady of the Lake Hospital, Inc.

Baton Rouge, Louisiana, 70808, United States

RECRUITING

LSU Health Sciences Center New Orleans

New Orleans, Louisiana, 70119, United States

RECRUITING

Trials365, LLC

Shreveport, Louisiana, 71133, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

USON - Minnesota Oncology Hematology

Minneapolis, Minnesota, 55404, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

St. Dominic's Gynecologic Oncology

Jackson, Mississippi, 39216, United States

RECRUITING

Midwest Ventures Group HCA MId America Division

Kansas City, Missouri, 64132, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63108, United States

WITHDRAWN

Intermountain Health St. Vincent Regional Hospital

Billings, Montana, 59101, United States

RECRUITING

Women's Cancer Center of Nevada

Las Vegas, Nevada, 89106, United States

RECRUITING

Center Of Hope

Reno, Nevada, 89511, United States

RECRUITING

Hackensack Meridian Health Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

RECRUITING

Women's Cancer Care Associates, LLC

Albany, New York, 12208, United States

RECRUITING

NYU Langone Hospital-Long Island

Mineola, New York, 11501, United States

RECRUITING

Northwell Health - Zuckerberg Cancer Center

New Hyde Park, New York, 11042, United States

RECRUITING

Mount Sinai Chelsea

New York, New York, 10011, United States

WITHDRAWN

Perlmutter Cancer Center at NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Mount Sinai

New York, New York, 10029, United States

WITHDRAWN

Lenox Hill Hospital

New York, New York, 10075, United States

RECRUITING

Northwell Health - Queens Cancer Center

Rego Park, New York, 11374, United States

RECRUITING

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

Atrium Health Levine Cancer Institute

Charlotte, North Carolina, 28209, United States

RECRUITING

Duke Cancer Center

Durham, North Carolina, 27710, United States

RECRUITING

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

MetroHealth

Cleveland, Ohio, 44109, United States

RECRUITING

Zangmeister Cancer Center

Columbus, Ohio, 43219, United States

RECRUITING

ProMedica Flower Hospital

Sylvania, Ohio, 43560, United States

RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Oklahoma Cancer Specialists and Research Institute, LLC

Tulsa, Oklahoma, 74146, United States

RECRUITING

Oncology Associates of Oregon

Eugene, Oregon, 97401, United States

RECRUITING

Providence Portland Medical Center

Portland, Oregon, 97213, United States

RECRUITING

Alliance Cancer Specialists

Langhorne, Pennsylvania, 19047, United States

RECRUITING

Magee - Women's Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Allegheny Health Network - West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Avera

Sioux Falls, South Dakota, 57105, United States

RECRUITING

Chattanooga's Program in Women's Oncology

Chattanooga, Tennessee, 37403, United States

WITHDRAWN

The West Clinic, PLLC dba West Cancer Center

Germantown, Tennessee, 38138, United States

WITHDRAWN

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

RECRUITING

University of Tennessee Health Science Center

Memphis, Tennessee, 38103, United States

RECRUITING

USON - Texas Oncology, Austin Central

Austin, Texas, 78731, United States

RECRUITING

Parkland Health & Hospital System

Dallas, Texas, 75235, United States

RECRUITING

Texas Oncology - Dallas

Dallas, Texas, 75246, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Texas Oncology - Fort Worth

Fort Worth, Texas, 76104, United States

WITHDRAWN

Houston Methodist

Houston, Texas, 77030, United States

RECRUITING

Texas Oncology - San Antonio

San Antonio, Texas, 78240, United States

RECRUITING

Texas Oncology - The Woodlands

The Woodlands, Texas, 77380, United States

RECRUITING

Texas Oncology, PC, Tyler

Tyler, Texas, 75702, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

Swedish Cancer Institute

Seattle, Washington, 98104, United States

RECRUITING

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

RECRUITING

Medical College of Wisconsin/ Freodtert Hospital

Milwaukee, Wisconsin, 53226, United States

WITHDRAWN

Border Medical Oncology & Haematology

Albury, New South Wales, 2640, Australia

RECRUITING

Macarthur Cancer Therapy Centre

Campbelltown, New South Wales, 2560, Australia

RECRUITING

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

RECRUITING

Central Coast LHD - Gosford & Wyong Hospitals

Gosford, New South Wales, 2250, Australia

RECRUITING

Newcastle Private Hospital

New Lambton Heights, New South Wales, 2305, Australia

RECRUITING

Royal North Shore Hospital

Saint Leonards, New South Wales, Australia

RECRUITING

Westmead Hospital

Wentworthville, New South Wales, 2145, Australia

RECRUITING

ICON Cancer Centre Southport

Southport, Queensland, 4215, Australia

RECRUITING

Toowoomba Hospital

Toowoomba, Queensland, 4350, Australia

RECRUITING

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

RECRUITING

Box Hill Hospital - Eastern Health (Oncology)

Box Hill, Victoria, 3128, Australia

RECRUITING

Monash Health

Clayton, Victoria, 3168, Australia

RECRUITING

Frankston Hospital

Frankston, Victoria, 3199, Australia

RECRUITING

Cabrini Health

Malvern, Victoria, 3144, Australia

RECRUITING

Peter MacCallum Cancer Centre/RWH/RMH

Melbourne, Victoria, 3000, Australia

WITHDRAWN

The Royal Adelaide Hospital

Southport, 5000, Australia

RECRUITING

Cliniques Universitaires St. Luc

Brussels, 1200, Belgium

RECRUITING

AZ Sint Lucas

Ghent, 9000, Belgium

RECRUITING

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

CHU Ambroise Pare

Mons, 7000, Belgium

RECRUITING

CHU UCL Namur, Site Sainte-Elisabeth

Namur, 5000, Belgium

RECRUITING

Tom Baker Cancer Centre

Calgary, Alberta, T3H2G5, Canada

RECRUITING

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

NOT YET RECRUITING

Nova Scotia Health / QEII Health Sciences Centre / Atlantic Clinical Cancer Research Unit

Halifax, Nova Scotia, B3H 2Y9, Canada

RECRUITING

Princess Margaret

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Sunnybrook Research Institute

Toronto, Ontario, M9L 2H9, Canada

RECRUITING

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0C1, Canada

RECRUITING

McGill University Health Centre (MUHC)

Montreal, Quebec, H4A3J1, Canada

RECRUITING

Hospital Maisonneuve-Rosemont

Montreal, Quebec, Canada

RECRUITING

University Hospital Brno

Brno, 60200, Czechia

RECRUITING

University Hospital Ostrava

Ostrava, 70852, Czechia

RECRUITING

UH Královské Vinohrady

Prague, 10034, Czechia

RECRUITING

General University Hospital in Prague

Prague, 12851, Czechia

RECRUITING

Hospital Na Bulovce

Prague, 18100, Czechia

RECRUITING

High Technology Hospital Medcenter

Batumi, 6000, Georgia

RECRUITING

Todua Clinic

Tbilisi, 0112, Georgia

RECRUITING

LTD New Hospitals

Tbilisi, 0114, Georgia

RECRUITING

Tbilisi Cancer Center

Tbilisi, 0156, Georgia

RECRUITING

JSC - K.Eristavi National Center of Experimental and Clinical Surgery

Tbilisi, 0159, Georgia

RECRUITING

Caucasus Medical Centre

Tbilisi, 0186, Georgia

RECRUITING

LTD Innova Medical Center

Tbilisi, 0186, Georgia

RECRUITING

Multiprofile Clinic "Consilium Medulla"

Tbilisi, 0186, Georgia

RECRUITING

Charite Berlin Universitatsmedizin

Berlin, 13353, Germany

RECRUITING

Universitätsklinikum Hamburg Eppendorf

Hamburg, 20246, Germany

RECRUITING

University Hospital Dresden

Kiel, 01307, Germany

RECRUITING

Universitatsklinikum Schleswig-Holstein

Kiel, 24105, Germany

RECRUITING

Helios Klinikum Krefeld

Krefeld, 47805, Germany

RECRUITING

Universitätsklinik Leipzig

Leipzig, 04103, Germany

RECRUITING

Universitätsfrauenklinik Mainz

Mainz, 55131, Germany

NOT YET RECRUITING

Universitätsmedizin Mannheim

Mannheim, 68167, Germany

RECRUITING

Klinik und Poliklinik fur Frauenheilkunde und Geburtshilfe GroBhadern

Munich, 80337, Germany

RECRUITING

Klinikum Südstadt Rostock

Rostock, 18059, Germany

RECRUITING

Universitätsfrauenklinik Ulm

Ulm, 89075, Germany

RECRUITING

IASO Hospital

Marousi, Athens, 151 23, Greece

RECRUITING

Alexandra Hospital

Athens, 11528, Greece

RECRUITING

Hygeia Hospital

Athens, 15123, Greece

RECRUITING

Euromedica General Clinic

Thessaloniki, 54645, Greece

RECRUITING

Unit of Gynecol.Oncol., Dept.Obstet.Gynecol., Clinical Center, University of Debrecen

Debrecen, 4032, Hungary

RECRUITING

Petz Aladár University Teaching Hospital

Győr, 9024, Hungary

RECRUITING

St. Vincent's University Hospital

Dublin, Elm Park, D04 T6F4, Ireland

NOT YET RECRUITING

Cork University Hospital

Cork, T12 DC4A, Ireland

RECRUITING

St. James Hospital

Dublin, D08 NHY1, Ireland

RECRUITING

Galway University

Galway, H91 YR71, Ireland

RECRUITING

University Hospital Waterford

Waterford, X91 ER8E, Ireland

RECRUITING

Hillel-Yaffe Medical Center

Hadera, 38100, Israel

RECRUITING

Wolfson Medical Center

Holon, Israel

RECRUITING

Hadassah Medical Center

Jerusalem, 91120, Israel

RECRUITING

Sheba Medical Center

Ramat Gan, 52621, Israel

RECRUITING

IRCCS Azienda Ospedaliero Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

ASST Spedali Civili Di Brescia

Brescia, 25123, Italy

RECRUITING

IRCCS Istituto Romagnolo Per Lo Studio Del Tumori "Dino Amadori" - IRST S.R.L.

Meldola, 47014, Italy

RECRUITING

San Raffaele Hospital

Milan, 20132, Italy

RECRUITING

Istituto Nazionale dei Tumori IRCCS - MILANO S. C. Ginecologia Oncologica

Milan, 20133, Italy

RECRUITING

Instituto Europeo di Oncologia

Milan, 20141, Italy

RECRUITING

Humanitas San Pio X Hospital

Milan, 20159, Italy

RECRUITING

Ospedale San Gerardo - Asst Monza

Monza, 20900, Italy

RECRUITING

"Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" - NAPOLI Struttura Complessa Oncologia Medica Uro-Ginecologica"

Naples, 20133, Italy

RECRUITING

Istituto Oncologico Veneto

Padova, 35128, Italy

RECRUITING

Universita di Pisa

Pisa, 56127, Italy

RECRUITING

Nuovo Ospedale di Prato

Prato, 59100, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli - ROMA

Roma, 00168, Italy

RECRUITING

Ospedale Ostetrico Ginecologico Sant'Anna

Torino, 10124, Italy

RECRUITING

AO Ordine Mauriziano

Torino, 10128, Italy

RECRUITING

St. Elisabeth Cancer Institute

Bratislava, 81250, Slovakia

RECRUITING

UH Bratislava

Bratislava, 82606, Slovakia

RECRUITING

National Cancer Institute

Bratislava, 83310, Slovakia

RECRUITING

UH Trenčín

Trenčín, 91101, Slovakia

RECRUITING

Soon Chun Hyang University Hospital Cheonan

Cheonan, Chungcheongnam-do, 31151, South Korea

RECRUITING

Severance Hospital (Yonsei University Health System)

Seoul, Seongbuk, 50-1, South Korea

RECRUITING

Samsung Changwon Hospital

Changwon, 51353, South Korea

RECRUITING

National Cancer Center (NCC)

Goyang-si, 323, South Korea

RECRUITING

CHA University/Bundang CHA General Hospital

Seongnam-si, 59, South Korea

NOT YET RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Gangnam Severance Hospital

Seoul, 06273, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seoul, 101, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, 73, South Korea

RECRUITING

Samsung Medical Center

Seoul, 81, South Korea

WITHDRAWN

Asan Medical Center

Seoul, 88, South Korea

RECRUITING

Hospital Universitario Donostia

Donostia / San Sebastian, Gipuzkoa, 20014, Spain

RECRUITING

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Zaragoza, 50009, Spain

RECRUITING

ICO Badalona

Badalona, 08916, Spain

RECRUITING

Hospital Universitari Vall d' Hebrón

Barcelona, 08035, Spain

RECRUITING

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Institut Catala d'Oncologia Hospitalet

Barcelona, 08908, Spain

RECRUITING

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

RECRUITING

Institut Catala d'Oncologia de Girona

Girona, 17007, Spain

RECRUITING

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

RECRUITING

MD Anderson Cancer Center Madrid

Madrid, 28033, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitario Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

H 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Hospital Universitatrio Virgen de la Victoria

Málaga, 29010, Spain

RECRUITING

Virgen de la Arrixaca University Clinical Hospital

Murcia, 30120, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

RECRUITING

Instituto Valenciano de Oncología

Valencia, 46009, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

RECRUITING

Hospital LaFe Uacenlia

Valencia, 46026, Spain

RECRUITING

Hospital Miguel Servet

Zaragoza, 50009, Spain

RECRUITING

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833401, Taiwan

RECRUITING

TaiChung Veterans General Hospital

Taichung, 407219, Taiwan

RECRUITING

Chi Mei Medical Center

Tainan, 71004, Taiwan

RECRUITING

Mackay Memorial Hospital

Taipei, 104217, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

Taipei Medical University- Shuang Ho Hospital, Ministry of Health and Welfare

Taipei, 23561, Taiwan

RECRUITING

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

RECRUITING

Ankara Baskent Hospital

Çankaya, Ankara, 34093, Turkey (Türkiye)

RECRUITING

Çukurova University

Adana, 01330, Turkey (Türkiye)

NOT YET RECRUITING

Adana Baskent Hospital

Adana, 34920, Turkey (Türkiye)

RECRUITING

Hacettepe University Oncology Hospital

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Memorial Ankara Hospital

Ankara, 06520, Turkey (Türkiye)

RECRUITING

Cerrahpasa University

Istanbul, 34098, Turkey (Türkiye)

NOT YET RECRUITING

Acibadem Atakent Hospital

Istanbul, 34303, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 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.

  • 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.

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

selinexor

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Karyopharm Medical Information

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blind placebo-controlled study
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2022

First Posted

November 10, 2022

Study Start

April 18, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

January 1, 2028

Last Updated

April 23, 2026

Record last verified: 2026-04

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