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Clinical Trials in Ireland / NCT05611931
Active, not recruiting Phase 3

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

NCT05611931 · tracked via the Priya Life Science Ireland tracker
Sponsor
Karyopharm Therapeutics Inc
Phase
Phase 3
Started
2023-04-18
Last updated
2026-08-27

Condition(s) studied

Endometrial Cancer

Investigational drug(s) / intervention(s)

Selinexor →Matching Placebo for selinexor

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

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: Patients must meet all of the following inclusion criteria in order to be eligible to participate in this study: * Adults (Aged ≥ 18 years) * Histologically confirmed endometrial cancer (endometrioid, serous, undifferentiated, or carcinosarcoma sub-types) that is TP53 wild type by central NGS * 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 Exclusion Criteria: Patients meeting any of the following exclusion criteria are not eligible to participate in this study: * 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

Primary outcome measure(s)

Trial sites (199)

FacilityCityRegionStatus
The University of Alabama at Birmingham Birmingham Alabama
Honor Health Phoenix Arizona
University of Arkansas for Medical Sciences Little Rock Arkansas
UC DAVIS Davis California
City of Hope National Medical Center Duarte California
City of Hope at Irvine Lennar Irvine California
Cancer and Blood Specialty Clinic Los Alamitos California
UCLA - Women's Health Clinical Research Unit Los Angeles California
Long Beach Memorial Medical Center Los Angeles California
Stanford University Palo Alto California
California Pacific Medical Center San Francisco California
Broward Health Medical Center Fort Lauderdale Florida
Mount Sinai Comprehensive Cancer Center Miami Beach Florida
Advent Health Orlando Florida
Grady Hospital Atlanta Georgia
Emory University Atlanta Georgia
Georgia Cancer Center at Augusta University Augusta Georgia
Illinois Cancer Specialists Arlington Heights Illinois
NorthShore University Health System Evanston Illinois
Northwest Cancer Center Dyer Indiana
Goshen Health Goshen Indiana
St Vincent Hospital Indianapolis Indiana
Memorial Hospital of South Bend South Bend Indiana
University of Iowa Iowa City Iowa
Our Lady of the Lake Hospital, Inc. Baton Rouge Louisiana
LSU Health Sciences Center New Orleans New Orleans Louisiana
Trials365, LLC Shreveport Louisiana
Tufts Medical Center Boston Massachusetts
Karmanos Cancer Institute Detroit Michigan
USON - Minnesota Oncology Hematology Minneapolis Minnesota
University of Minnesota Minneapolis Minnesota
St. Dominic's Gynecologic Oncology Jackson Mississippi
Midwest Ventures Group HCA MId America Division Kansas City Missouri
Intermountain Health St. Vincent Regional Hospital Billings Montana
Women's Cancer Center of Nevada Las Vegas Nevada
Center Of Hope Reno Nevada
Women's Cancer Care Associates, LLC Albany New York
NYU Langone Hospital-Long Island Mineola New York
Northwell Health - Zuckerberg Cancer Center New Hyde Park New York
Perlmutter Cancer Center at NYU Langone Health New York New York

+ 159 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05611931 on ClinicalTrials.gov ↗ ← All trials in Ireland