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Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma
Sponsor: Karyopharm Therapeutics Inc
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
257
Start Date
2023-04-18
Completion Date
2028-01
Last Updated
2026-10-29
Healthy Volunteers
No
Conditions
Interventions
Selinexor
Dose: 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral
Matching Placebo for selinexor
Dose:60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral
Locations (185)
The University of Alabama at Birmingham
Birmingham, Alabama, United States
Honor Health
Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
UC DAVIS
Davis, California, United States
City of Hope National Medical Center
Duarte, California, United States
City of Hope at Irvine Lennar
Irvine, California, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
UCLA - Women's Health Clinical Research Unit
Los Angeles, California, United States
Long Beach Memorial Medical Center
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
California Pacific Medical Center
San Francisco, California, United States
Broward Health Medical Center
Fort Lauderdale, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Advent Health
Orlando, Florida, United States
Grady Hospital
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
NorthShore University Health System
Evanston, Illinois, United States
Northwest Cancer Center
Dyer, Indiana, United States
Goshen Health
Goshen, Indiana, United States
St Vincent Hospital
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
LSU Health Sciences Center New Orleans
New Orleans, Louisiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
USON - Minnesota Oncology Hematology
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
St. Dominic's Gynecologic Oncology
Jackson, Mississippi, United States
Midwest Ventures Group HCA MId America Division
Kansas City, Missouri, United States
Intermountain Health St. Vincent Regional Hospital
Billings, Montana, 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
Northwell Health - Zuckerberg Cancer Center
New Hyde Park, New York, United States
Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
Northwell Health - Queens Cancer Center
Rego Park, New York, United States
University of Rochester
Rochester, New York, United States
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, United States
Duke Cancer Center
Durham, North Carolina, United States
MetroHealth
Cleveland, 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
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, United States
Oncology Associates of Oregon
Eugene, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Alliance Cancer Specialists
Langhorne, Pennsylvania, United States
Magee - Women's Hospital
Pittsburgh, Pennsylvania, United States
Allegheny Health Network - West Penn Hospital
Pittsburgh, Pennsylvania, United States
Avera
Sioux Falls, South Dakota, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
University of Tennessee Health Science Center
Memphis, Tennessee, United States
USON - Texas Oncology, Austin Central
Austin, Texas, United States
Parkland Health & Hospital System
Dallas, Texas, United States
Texas Oncology - Dallas
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, 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 Utah
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Border Medical Oncology & Haematology
Albury, New South Wales, Australia
Macarthur Cancer Therapy Centre
Campbelltown, 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
Royal North Shore Hospital
Saint Leonards, 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
The Royal Adelaide Hospital
Southport, Australia
Cliniques Universitaires St. Luc
Brussels, Belgium
AZ Sint Lucas
Ghent, Belgium
UZ Leuven
Leuven, Belgium
CHU Ambroise Pare
Mons, Belgium
CHU UCL Namur, Site Sainte-Elisabeth
Namur, Belgium
Cross Cancer Institute
Edmonton, Alberta, Canada
Princess Margaret
Toronto, Ontario, Canada
Sunnybrook Research Institute
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
Hospital Maisonneuve-Rosemont
Montreal, Quebec, Canada
University Hospital Brno
Brno, Czechia
University Hospital Ostrava
Ostrava, Czechia
UH Královské Vinohrady
Prague, Czechia
General University Hospital in Prague
Prague, Czechia
Hospital Na Bulovce
Prague, Czechia
High Technology Hospital Medcenter
Batumi, Georgia
Todua Clinic
Tbilisi, Georgia
LTD New Hospitals
Tbilisi, Georgia
Tbilisi Cancer Center
Tbilisi, Georgia