RECRUITING

Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

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Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-04-18
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05611931

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults (Aged ≥ 18 years)
  2. * 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
  3. * 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
  4. * Must be able to initiate C1D1 within 3-8 weeks after last platinum dose
  5. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  6. * Adequate bone marrow function and organ function
  1. * Uterine sarcomas, clear cell or small cell carcinoma with neuroendocrine differentiation
  2. * Palliative radiotherapy administered within 14 days of intended C1D1
  3. * Any gastrointestinal dysfunction that could interfere with the absorption of oral study therapy
  4. * Serious psychiatric or medical conditions that could interfere with study participation or would make study involvement unreasonably hazardous
  5. * Previous treatment with an XPO1 inhibitor
  6. * Stable disease or disease progression after platinum-based chemotherapy
  7. * Pregnancy, breastfeeding, or other legal/ethical restrictions to trial participation
  8. * Known dMMR/MSI-H EC tumors that are medically eligible to receive an immune checkpoint inhibitor

Contacts and Locations

Study Contact

Karyopharm Medical Information
CONTACT
(888) 209-9326
clinicaltrials@karyopharm.com

Study Locations (Sites)

The University of Alabama at Birmingham
Birmingham, Alabama, 35205
United States
Honor Health
Phoenix, Arizona, 85016
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
UC DAVIS
Davis, California, 95616
United States
City of Hope National Medical Center
Duarte, California, 91010
United States
Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
United States
City of Hope at Irvine Lennar
Irvine, California, 92618
United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720
United States
UCLA - Women's Health Clinical Research Unit
Los Angeles, California, 90095
United States
Long Beach Memorial Medical Center
Los Angeles, California, 90806
United States
UC Irvine
Orange, California, 92868
United States
Stanford University
Palo Alto, California, 94304
United States
California Pacific Medical Center
San Francisco, California, 94109
United States
Highlands Ranch Hospital
Highlands Ranch, Colorado, 80129
United States
University of Colorado Cancer Center
Highlands Ranch, Colorado, 80129
United States
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
United States
Advent Health
Orlando, Florida, 32804
United States
Grady Hospital
Atlanta, Georgia, 30303
United States
Emory University
Atlanta, Georgia, 30322
United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912
United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
United States
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005
United States
NorthShore University Health System
Evanston, Illinois, 60201
United States
Northwest Cancer Center
Dyer, Indiana, 46311
United States
Goshen Health
Goshen, Indiana, 46526
United States
St Vincent Hospital
Indianapolis, Indiana, 46260
United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601
United States
University of Iowa
Iowa City, Iowa, 52242
United States
Our Lady of the Lake Hospital, Inc.
Baton Rouge, Louisiana, 70808
United States
LSU Health Sciences Center New Orleans
New Orleans, Louisiana, 70119
United States
Trials365, LLC
Shreveport, Louisiana, 71133
United States
Tufts Medical Center
Boston, Massachusetts, 02111
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
USON - Minnesota Oncology Hematology
Minneapolis, Minnesota, 55404
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
St. Dominic's Gynecologic Oncology
Jackson, Mississippi, 39216
United States
Midwest Ventures Group HCA MId America Division
Kansas City, Missouri, 64132
United States
Washington University School of Medicine
St Louis, Missouri, 63108
United States
Intermountain Health St. Vincent Regional Hospital
Billings, Montana, 59101
United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89106
United States
Center Of Hope
Reno, Nevada, 89511
United States
Hackensack Meridian Health Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
United States
Women's Cancer Care Associates, LLC
Albany, New York, 12208
United States
NYU Langone Hospital-Long Island
Mineola, New York, 11501
United States
Northwell Health - Zuckerberg Cancer Center
New Hyde Park, New York, 11042
United States
Mount Sinai Chelsea
New York, New York, 10011
United States
Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
United States
Mount Sinai
New York, New York, 10029
United States
Lenox Hill Hospital
New York, New York, 10075
United States
Northwell Health - Queens Cancer Center
Rego Park, New York, 11374
United States
University of Rochester
Rochester, New York, 14642
United States
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, 28209
United States
Duke Cancer Center
Durham, North Carolina, 27710
United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
United States
MetroHealth
Cleveland, Ohio, 44109
United States
Zangmeister Cancer Center
Columbus, Ohio, 43219
United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, 74146
United States
Oncology Associates of Oregon
Eugene, Oregon, 97401
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Alliance Cancer Specialists
Langhorne, Pennsylvania, 19047
United States
Magee - Women's Hospital
Pittsburgh, Pennsylvania, 15213
United States
Allegheny Health Network - West Penn Hospital
Pittsburgh, Pennsylvania, 15224
United States
Avera
Sioux Falls, South Dakota, 57105
United States
Chattanooga's Program in Women's Oncology
Chattanooga, Tennessee, 37403
United States
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee, 38138
United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
United States
University of Tennessee Health Science Center
Memphis, Tennessee, 38103
United States
USON - Texas Oncology, Austin Central
Austin, Texas, 78731
United States
Parkland Health & Hospital System
Dallas, Texas, 75235
United States
Texas Oncology - Dallas
Dallas, Texas, 75246
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
Texas Oncology - Fort Worth
Fort Worth, Texas, 76104
United States
Houston Methodist
Houston, Texas, 77030
United States
Texas Oncology - San Antonio
San Antonio, Texas, 78240
United States
Texas Oncology - The Woodlands
The Woodlands, Texas, 77380
United States
Texas Oncology, PC, Tyler
Tyler, Texas, 75702
United States
University of Utah
Salt Lake City, Utah, 84112
United States
University of Virginia
Charlottesville, Virginia, 22908
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
United States
Medical College of Wisconsin/ Freodtert Hospital
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Karyopharm Therapeutics Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-18
Study Completion Date2028-01

Study Record Updates

Study Start Date2023-04-18
Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

  • Selinexor
  • KPT-330
  • Advanced or Recurrent Endometrial Carcinoma
  • XPORT-EC
  • ENGOT-EN20
  • GOG-3083
  • XPORT-EC-042
  • p53 wild-type
  • Tumor protein 53 wild-type

Additional Relevant MeSH Terms

  • Endometrial Cancer