A Phase 3, 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
Status: Recruiting
Location: See all (215) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
The University of Alabama at Birmingham
RECRUITING
Birmingham
Arkansas
University of Arkansas for Medical Sciences
RECRUITING
Little Rock
Arizona
Honor Health
RECRUITING
Phoenix
California
UC DAVIS
NOT_YET_RECRUITING
Davis
City of Hope National Medical Center
RECRUITING
Duarte
Chao Family Comprehensive Cancer Center and Ambulatory Care
WITHDRAWN
Irvine
City of Hope at Irvine Lennar
RECRUITING
Irvine
Cancer and Blood Specialty Clinic
NOT_YET_RECRUITING
Los Alamitos
Long Beach Memorial Medical Center
RECRUITING
Los Angeles
UCLA - Women's Health Clinical Research Unit
RECRUITING
Los Angeles
UC Irvine
WITHDRAWN
Orange
Stanford University
RECRUITING
Palo Alto
California Pacific Medical Center
RECRUITING
San Francisco
Colorado
Highlands Ranch Hospital
WITHDRAWN
Highlands Ranch
University of Colorado Cancer Center
WITHDRAWN
Highlands Ranch
Florida
Broward Health Medical Center
RECRUITING
Fort Lauderdale
Mount Sinai Comprehensive Cancer Center
RECRUITING
Miami Beach
Advent Health
RECRUITING
Orlando
Georgia
Emory University
RECRUITING
Atlanta
Grady Hospital
RECRUITING
Atlanta
Georgia Cancer Center at Augusta University
RECRUITING
Augusta
Northeast Georgia Medical Center
RECRUITING
Gainesville
Iowa
University of Iowa
RECRUITING
Iowa City
Illinois
Illinois Cancer Specialists
RECRUITING
Arlington Heights
NorthShore University Health System
RECRUITING
Evanston
Indiana
Northwest Cancer Center
RECRUITING
Dyer
Goshen Health
RECRUITING
Goshen
St Vincent Hospital
RECRUITING
Indianapolis
Memorial Hospital of South Bend
RECRUITING
South Bend
Louisiana
Our Lady of the Lake Hospital, Inc.
RECRUITING
Baton Rouge
LSU Health Sciences Center New Orleans
RECRUITING
New Orleans
Trials365, LLC
RECRUITING
Shreveport
Massachusetts
Tufts Medical Center
RECRUITING
Boston
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
Minnesota
University of Minnesota
RECRUITING
Minneapolis
USON - Minnesota Oncology Hematology
RECRUITING
Minneapolis
Missouri
Midwest Ventures Group HCA MId America Division
RECRUITING
Kansas City
Washington University School of Medicine
WITHDRAWN
St Louis
Mississippi
St. Dominic's Gynecologic Oncology
RECRUITING
Jackson
Montana
Intermountain Health St. Vincent Regional Hospital
RECRUITING
Billings
North Carolina
Atrium Health Levine Cancer Institute
RECRUITING
Charlotte
Duke Cancer Center
RECRUITING
Durham
New Jersey
Hackensack Meridian Health Jersey Shore University Medical Center
NOT_YET_RECRUITING
Neptune City
Nevada
Women's Cancer Center of Nevada
RECRUITING
Las Vegas
Center Of Hope
RECRUITING
Reno
New York
Women's Cancer Care Associates, LLC
RECRUITING
Albany
NYU Langone Hospital-Long Island
RECRUITING
Mineola
Northwell Health - Zuckerberg Cancer Center
RECRUITING
New Hyde Park
Lenox Hill Hospital
RECRUITING
New York
Mount Sinai
WITHDRAWN
New York
Mount Sinai Chelsea
WITHDRAWN
New York
Perlmutter Cancer Center at NYU Langone Health
RECRUITING
New York
Northwell Health - Queens Cancer Center
RECRUITING
Rego Park
University of Rochester
RECRUITING
Rochester
Ohio
University of Cincinnati Medical Center
RECRUITING
Cincinnati
MetroHealth
RECRUITING
Cleveland
Zangmeister Cancer Center
RECRUITING
Columbus
ProMedica Flower Hospital
RECRUITING
Sylvania
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Oklahoma Cancer Specialists and Research Institute, LLC
RECRUITING
Tulsa
Oregon
Oncology Associates of Oregon
RECRUITING
Eugene
Providence Portland Medical Center
RECRUITING
Portland
Pennsylvania
Alliance Cancer Specialists
RECRUITING
Langhorne
Allegheny Health Network - West Penn Hospital
RECRUITING
Pittsburgh
Magee - Women's Hospital
NOT_YET_RECRUITING
Pittsburgh
South Dakota
Avera
RECRUITING
Sioux Falls
Tennessee
Chattanooga's Program in Women's Oncology
WITHDRAWN
Chattanooga
The West Clinic, PLLC dba West Cancer Center
WITHDRAWN
Germantown
University of Tennessee Medical Center
RECRUITING
Knoxville
University of Tennessee Health Science Center
RECRUITING
Memphis
Texas
USON - Texas Oncology, Austin Central
RECRUITING
Austin
Parkland Health & Hospital System
RECRUITING
Dallas
Texas Oncology - Dallas
RECRUITING
Dallas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Texas Oncology - Fort Worth
WITHDRAWN
Fort Worth
Houston Methodist
RECRUITING
Houston
Texas Oncology - San Antonio
RECRUITING
San Antonio
Texas Oncology - The Woodlands
RECRUITING
The Woodlands
Texas Oncology, PC, Tyler
RECRUITING
Tyler
Utah
University of Utah
RECRUITING
Salt Lake City
Virginia
University of Virginia
RECRUITING
Charlottesville
Washington
Swedish Cancer Institute
NOT_YET_RECRUITING
Seattle
Wisconsin
University of Wisconsin Hospital and Clinics
RECRUITING
Madison
Medical College of Wisconsin/ Freodtert Hospital
WITHDRAWN
Milwaukee
Other Locations
Australia
Border Medical Oncology & Haematology
RECRUITING
Albury
Box Hill Hospital - Eastern Health (Oncology)
RECRUITING
Box Hill
Macarthur Cancer Therapy Centre
RECRUITING
Campbelltown
Chris O'Brien Lifehouse
RECRUITING
Camperdown
Monash Health
RECRUITING
Clayton
Frankston Hospital
RECRUITING
Frankston
Central Coast LHD - Gosford & Wyong Hospitals
RECRUITING
Gosford
Royal Hobart Hospital
RECRUITING
Hobart
Cabrini Health
RECRUITING
Malvern
Peter MacCallum Cancer Centre/RWH/RMH
WITHDRAWN
Melbourne
Newcastle Private Hospital
RECRUITING
New Lambton Heights
Royal North Shore Hospital
RECRUITING
Saint Leonards
ICON Cancer Centre Southport
RECRUITING
Southport
The Royal Adelaide Hospital
RECRUITING
Southport
Toowoomba Hospital
RECRUITING
Toowoomba
Westmead Hospital
RECRUITING
Wentworthville
Belgium
Cliniques Universitaires St. Luc
RECRUITING
Brussels
AZ Sint Lucas
RECRUITING
Ghent
UZ Leuven
RECRUITING
Leuven
CHU Ambroise Pare
RECRUITING
Mons
CHU UCL Namur, Site Sainte-Elisabeth
RECRUITING
Namur
Canada
Tom Baker Cancer Centre
NOT_YET_RECRUITING
Calgary
Cross Cancer Institute
NOT_YET_RECRUITING
Edmonton
Nova Scotia Health / QEII Health Sciences Centre / Atlantic Clinical Cancer Research Unit
RECRUITING
Halifax
Centre Hospitalier de l'Université de Montréal
RECRUITING
Montreal
Hospital Maisonneuve-Rosemont
RECRUITING
Montreal
McGill University Health Centre (MUHC)
RECRUITING
Montreal
Princess Margaret
RECRUITING
Toronto
Sunnybrook Research Institute
RECRUITING
Toronto
Georgia
High Technology Hospital Medcenter
RECRUITING
Batumi
Caucasus Medical Centre
RECRUITING
Tbilisi
JSC - K.Eristavi National Center of Experimental and Clinical Surgery
NOT_YET_RECRUITING
Tbilisi
LTD Innova Medical Center
RECRUITING
Tbilisi
LTD New Hospitals
RECRUITING
Tbilisi
Multiprofile Clinic Consilium Medulla
RECRUITING
Tbilisi
Tbilisi Cancer Center
RECRUITING
Tbilisi
Todua Clinic
NOT_YET_RECRUITING
Tbilisi
Germany
Charite Berlin Universitatsmedizin
RECRUITING
Berlin
Universitätsklinikum Hamburg Eppendorf
RECRUITING
Hamburg
Universitatsklinikum Schleswig-Holstein
RECRUITING
Kiel
University Hospital Dresden
RECRUITING
Kiel
Helios Klinikum Krefeld
NOT_YET_RECRUITING
Krefeld
Universitätsklinik Leipzig
RECRUITING
Leipzig
Universitätsfrauenklinik Mainz
NOT_YET_RECRUITING
Mainz
Universitätsmedizin Mannheim
RECRUITING
Mannheim
Klinik und Poliklinik fur Frauenheilkunde und Geburtshilfe GroBhadern
RECRUITING
Munich
Klinikum Südstadt Rostock
RECRUITING
Rostock
Universitätsfrauenklinik Ulm
RECRUITING
Ulm
Greece
Alexandra Hospital
RECRUITING
Athens
Hygeia Hospital
RECRUITING
Athens
IASO Hospital
RECRUITING
Marousi
Euromedica General Clinic
RECRUITING
Thessaloniki
Hungary
Unit of Gynecol.Oncol., Dept.Obstet.Gynecol., Clinical Center, University of Debrecen
RECRUITING
Debrecen
Petz Aladár University Teaching Hospital
RECRUITING
Győr
Ireland
Cork University Hospital
RECRUITING
Cork
St. James Hospital
RECRUITING
Dublin
St. Vincent's University Hospital
NOT_YET_RECRUITING
Dublin
Galway University
RECRUITING
Galway
University Hospital Waterford
RECRUITING
Waterford
Israel
Hillel-Yaffe Medical Center
RECRUITING
Hadera
Wolfson Medical Center
RECRUITING
Holon
Hadassah Medical Center
RECRUITING
Jerusalem
Sheba Medical Center
RECRUITING
Ramat Gan
Italy
IRCCS Azienda Ospedaliero Universitaria di Bologna
RECRUITING
Bologna
ASST Spedali Civili Di Brescia
RECRUITING
Brescia
IRCCS Istituto Romagnolo Per Lo Studio Del Tumori Dino Amadori - IRST S.R.L.
RECRUITING
Meldola
Humanitas San Pio X Hospital
RECRUITING
Milan
Instituto Europeo di Oncologia
RECRUITING
Milan
Istituto Nazionale dei Tumori IRCCS - MILANO S. C. Ginecologia Oncologica
RECRUITING
Milan
San Raffaele Hospital
RECRUITING
Milan
Ospedale San Gerardo - Asst Monza
RECRUITING
Monza
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - NAPOLI Struttura Complessa Oncologia Medica Uro-Ginecologica
RECRUITING
Napoli
Istituto Oncologico Veneto
RECRUITING
Padua
Universita di Pisa
RECRUITING
Pisa
Nuovo Ospedale di Prato
RECRUITING
Prato
Fondazione Policlinico Universitario Agostino Gemelli - ROMA
RECRUITING
Roma
AO Ordine Mauriziano
RECRUITING
Torino
Ospedale Ostetrico Ginecologico Sant'Anna
RECRUITING
Torino
Republic of Korea
Samsung Changwon Hospital
NOT_YET_RECRUITING
Changwon
Soon Chun Hyang University Hospital Cheonan
NOT_YET_RECRUITING
Cheonan
National Cancer Center (NCC)
NOT_YET_RECRUITING
Goyang-si
CHA University/Bundang CHA General Hospital
NOT_YET_RECRUITING
Seongnam-si
Asan Medical Center
NOT_YET_RECRUITING
Seoul
Gangnam Severance Hospital
NOT_YET_RECRUITING
Seoul
Korea University Anam Hospital
NOT_YET_RECRUITING
Seoul
Samsung Medical Center
NOT_YET_RECRUITING
Seoul
Seoul National University Bundang Hospital
NOT_YET_RECRUITING
Seoul
Seoul National University Hospital
NOT_YET_RECRUITING
Seoul
Seoul St. Mary's Hospital
NOT_YET_RECRUITING
Seoul
Severance Hospital (Yonsei University Health System)
NOT_YET_RECRUITING
Seoul
Slovakia
National Cancer Institute
RECRUITING
Bratislava
St. Elisabeth Cancer Institute
RECRUITING
Bratislava
UH Bratislava
RECRUITING
Bratislava
UH Trenčín
RECRUITING
Trenčín
Spain
ICO Badalona
RECRUITING
Badalona
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital Universitari Vall d' Hebrón
RECRUITING
Barcelona
Institut Catala d'Oncologia Hospitalet
RECRUITING
Barcelona
Hospital Universitario Reina Sofía
RECRUITING
Córdoba
Hospital Universitario Donostia
RECRUITING
Donostia / San Sebastian
Institut Catala d'Oncologia de Girona
RECRUITING
Girona
Hospital Universitario Virgen de las Nieves
RECRUITING
Granada
H 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Clinico San Carlos
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
MD Anderson Cancer Center Madrid
RECRUITING
Madrid
Hospital Universitatrio Virgen de la Victoria
RECRUITING
Málaga
Virgen de la Arrixaca University Clinical Hospital
RECRUITING
Murcia
Hospital Universitario Virgen del Rocío
RECRUITING
Seville
Hospital Clínico Universitario de Valencia
RECRUITING
Valencia
Hospital LaFe Uacenlia
RECRUITING
Valencia
Instituto Valenciano de Oncología
RECRUITING
Valencia
Hospital Clínico Universitario Lozano Blesa
RECRUITING
Zaragoza
Hospital Miguel Servet
RECRUITING
Zaragoza
Taiwan
Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
TaiChung Veterans General Hospital
NOT_YET_RECRUITING
Taichung
Chi Mei Medical Center
NOT_YET_RECRUITING
Tainan
Mackay Memorial Hospital
RECRUITING
Taipei
Taipei Medical University- Shuang Ho Hospital, Ministry of Health and Welfare
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Chang Gung Memorial Hospital
RECRUITING
Taoyuan
Turkey
Adana Baskent Hospital
NOT_YET_RECRUITING
Adana
Çukurova University
NOT_YET_RECRUITING
Adana
Hacettepe University Oncology Hospital
NOT_YET_RECRUITING
Ankara
Memorial Ankara Hospital
NOT_YET_RECRUITING
Ankara
Ankara Baskent Hospital
NOT_YET_RECRUITING
Çankaya
Istanbul University Capa Hospital
NOT_YET_RECRUITING
Fatih
Acibadem Atakent Hospital
NOT_YET_RECRUITING
Istanbul
Cerrahpasa University
NOT_YET_RECRUITING
Istanbul
Ankara University
NOT_YET_RECRUITING
Yenimahalle
Contact Information
Primary
Karyopharm Medical Information
clinicaltrials@karyopharm.com
(888) 209-9326
Time Frame
Start Date: 2023-04-18
Estimated Completion Date: 2028-01
Participants
Target number of participants: 276
Treatments
Experimental: 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.
Placebo_comparator: Placebo
Participants will receive matching placebo for selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle.
Related Therapeutic Areas
Sponsors
Collaborators: Cancer Trials Ireland (CTI), Australia New Zealand Gynaecological Oncology Group, The Central and Eastern European Gynecologic Oncology Group, Grupo Español de Investigación en Cáncer de Ovario, Israeli Society of Gynecologic Oncology, Hellenic Cooperative Oncology Group (HeCOG), European Network of Gynaecological Oncological Trial Groups (ENGOT), North Eastern German Society of Gynaecological Oncology, Mario Negri Gynecologic Oncology group (MaNGO), Multicenter Italian Trials in Ovarian Cancer (MITO), GOG Foundation, Belgian Gynaecological Oncology Group
Leads: Karyopharm Therapeutics Inc