Spots Global Cancer Trial Database for Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma
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Trial Identification
Brief Title: Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma
Official Title: 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
Study ID: NCT05611931
Conditions
Study Description
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 220 participants will be enrolled in the study and randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The University of Alabama at Birmingham, Birmingham, Alabama, United States
Honor Health, Phoenix, Arizona, United States
UCLA - Women's Health Clinical Research Unit, Los Angeles, California, United States
Long Beach Memorial Medical Center, Los Angeles, California, United States
UC Irvine, Orange, California, United States
Stanford University, Palo Alto, California, United States
California Pacific Medical Center, San Francisco, California, United States
Highlands Ranch Hospital, Highlands Ranch, Colorado, United States
University of Colorado Cancer Center, Highlands Ranch, Colorado, United States
Broward Health Medical Center, Fort Lauderdale, Florida, United States
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
Emory University, Atlanta, Georgia, United States
Northeast Georgia Medical Center, Gainesville, Georgia, United States
Illinois Cancer Specialists, Arlington Heights, Illinois, United States
St Vincent Hospital, Indianapolis, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Our Lady of the Lake Hospital, Inc., Baton Rouge, Louisiana, United States
LSU Health Sciences Center New Orleans, New Orleans, Louisiana, United States
Trials365, LLC, Shreveport, Louisiana, United States
Tufts Medical Center, Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
St. Dominic's Gynecologic Oncology, Jackson, Mississippi, United States
Midwest Ventures Group HCA MId America Division, Kansas City, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Women's Cancer Center of Nevada, Las Vegas, Nevada, United States
Center Of Hope, Reno, Nevada, United States
Women's Cancer Care Associates, LLC, Albany, New York, United States
NYU Langone Hospital-Long Island, Mineola, New York, United States
Mount Sinai Chelsea, New York, New York, United States
Perlmutter Cancer Center at NYU Langone Health, New York, New York, United States
Mount Sinai, New York, New York, United States
Duke Cancer Center, Durham, North Carolina, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
Zangmeister Cancer Center, Columbus, Ohio, United States
ProMedica Flower Hospital, Sylvania, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Oncology Associates of Oregon, Eugene, Oregon, United States
Providence Portland Medical Center, Portland, Oregon, United States
Allegheny Health Network - West Penn Hospital, Pittsburgh, Pennsylvania, United States
Avera, Sioux Falls, South Dakota, United States
Chattanooga's Program in Women's Oncology, Chattanooga, Tennessee, United States
The West Clinic, PLLC dba West Cancer Center, Germantown, Tennessee, United States
University of Tennessee Medical Center, Knoxville, Tennessee, United States
Texas Oncology - Dallas, Dallas, Texas, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Texas Oncology - Fort Worth, Fort Worth, Texas, United States
Houston Methodist, Houston, Texas, United States
Texas Oncology - San Antonio, San Antonio, Texas, United States
Texas Oncology - The Woodlands, The Woodlands, Texas, United States
Texas Oncology, PC, Tyler, Tyler, Texas, United States
University of Virginia, Charlottesville, Virginia, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Medical College of Wisconsin/ Freodtert Hospital, Milwaukee, Wisconsin, United States
Border Medical Oncology and Haematology, Albury East, New South Wales, Australia
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
Central Coast LHD - Gosford & Wyong Hospitals, Gosford, New South Wales, Australia
Newcastle Private Hospital, New Lambton Heights, New South Wales, Australia
Westmead Hospital, Wentworthville, New South Wales, Australia
ICON Cancer Centre Southport, Southport, Queensland, Australia
Toowoomba Hospital, Toowoomba, Queensland, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Box Hill Hospital - Eastern Health (Oncology), Box Hill, Victoria, Australia
Monash Health, Clayton, Victoria, Australia
Frankston Hospital, Frankston, Victoria, Australia
Cabrini Health, Malvern, Victoria, Australia
Peter MacCallum Cancer Centre/RWH/RMH, Melbourne, Victoria, Australia
The Royal Adelaide Hospital, Southport, , Australia
Cliniques Universitaires St. Luc, Bruxelles, , Belgium
AZ Sint Lucas, Gent, , Belgium
UZ Leuven, Leuven, , Belgium
CHU Ambroise Pare, Mons, , Belgium
CHU UCL Namur, Site Sainte-Elisabeth, Namur, , Belgium
Nova Scotia Health / QEII Health Sciences Centre / Atlantic Clinical Cancer Research Unit, Halifax, Nova Scotia, Canada
Sunnybrook Research Institute, Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada
McGill University Health Centre (MUHC), Montréal, Quebec, Canada
University Hospital Brno, Brno, , Czechia
UH Královské Vinohrady, Prague, , Czechia
High Technology Hospital Medcenter, Batumi, , Georgia
Tbilisi Cancer Center, Tbilisi, , Georgia
Caucasus Medical Centre, Tbilisi, , Georgia
LTD Innova Medical Center, Tbilisi, , Georgia
Multiprofile Clinic "Consilium Medulla", Tbilisi, , Georgia
Universitätsfrauenklinik Ulm, Ulm, , Germany
ALEXANDRA Hospital, Athens, , Greece
Hygeia Hospital, Athens, , Greece
Euromedica General Clinic, Thessaloníki, , Greece
Unit of Gynecol.Oncol., Dept.Obstet.Gynecol., Clinical Center, University of Debrecen, Debrecen, , Hungary
Cork University Hospital, Cork, , Ireland
St. James Hospital, Dublin, , Ireland
Hillel-Yaffe Medical Center, Hadera, , Israel
Wolfson Medical Center, Holon, , Israel
Hadassah Medical Center, Jerusalem, , Israel
Sheba Medical Center, Ramat Gan, , Israel
IRCCS Azienda Ospedaliero Universitaria di Bologna, Bologna, , Italy
ASST Spedali Civili Di Brescia, Brescia, , Italy
IRCCS Istituto Romagnolo Per Lo Studio Del Tumori "Dino Amadori" - IRST S.R.L., Meldola, , Italy
Instituto Europeo di Oncologia, Milano, , Italy
San Raffaele Hospital, Milan, , Italy
Ospedale San Gerardo - Asst Monza, Monza, , Italy
"Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" - NAPOLI Struttura Complessa Oncologia Medica Uro-Ginecologica", Napoli, , Italy
Nuovo Ospedale di Prato, Prato, , Italy
AO Ordine Mauriziano, Torino, , Italy
St. Elisabeth Cancer Institute, Bratislava, , Slovakia
National Cancer Institute, Bratislava, , Slovakia
Hospital Universitario Reina Sofía, Córdoba, Andalucia, Spain
ICO Badalona, Badalona, , Spain
Hospital Universitari Vall d' Hebrón, Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Institut Catala d'Oncologia Hospitalet, Barcelona, , Spain
Hospital Universitario Reina Sofía, Córdoba, , Spain
Virgen de la Arrixaca University Clinical Hospital, El Palmar Murcia, , Spain
Hospital Universitario Donostia, Gipuzkoa, , Spain
Hospital Universitario Virgen de las Nieves, Granada, , Spain
MD Anderson Cancer Center Madrid, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Universitario Clinico San Carlos, Madrid, , Spain
H 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitatrio Virgen de la Victoria, Malaga, , Spain
Hospital Universitatrio Virgen de la Victoria, Málaga, , Spain
Hospital Universitario Virgen del Rocío, Sevilla, , Spain
Instituto Valenciano de Oncología, Valencia, , Spain
Hospital Clínico Universitario de Valencia, Valencia, , Spain
Hospital LaFe Uacenlia, Valencia, , Spain
Hospital Clínico Universitario Lozano Blesa, Zaragoza, , Spain
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