A Phase 3 interventional study of Selinexor and Matching Placebo for selinexor in Endometrial Cancer, sponsored by Karyopharm Therapeutics Inc. Active, not recruiting at 191 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Karyopharm Therapeutics Inc · Phase 3, Interventional, and Treatment
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.
1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.
This study's enrollment of 257 is above the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →Karyopharm Therapeutics Inc is the lead sponsor of 36 studies on the registry; 4 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 14 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Patients must meet all of the following inclusion criteria in order to be eligible to participate in this study:
Exclusion Criteria: Patients meeting any of the following exclusion criteria are not eligible to participate in this study:
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.
Drug: Selinexor
Participants will receive matching placebo for selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle.
Drug: Matching Placebo for selinexor
Dose: 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral
Also known as: KPT-330
Dose:60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral
Investigator assessed Progression Free Survival (PFS) per RECIST v1.1
Time frame: From randomization until disease progression (PD) or death, whichever occurs first (up to 34 months)
Overall Survival (OS)
Time from randomization to death due to any cause
Time frame: Up to 34 months
Safety and tolerability of study drug (selinexor and placebo)
The safety and tolerability of study drug (selinexor and placebo) will be evaluated based on adverse event (AE) reports, physical examination results (including vital signs), and clinical laboratory results, by means of the occurrence, nature, and severity of AEs via Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0.
Time frame: From start of study drug administration up to 34 months
Time to First Subsequent Therapy (TFST)
Time from randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first
Time frame: From randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months)
Time to Second Subsequent Therapy (TSST)
Time from randomization until date of initiation of second therapy after discontinuation of study drug or death, whichever occurs first
Time frame: From randomization until date of initiation of second therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months)
Progression-free survival after initiating a next-line treatment (PFS2)
Time from randomization until the progression event after initiating a next-line treatment or death due to any cause, whichever occurs first
Time frame: From randomization until the next-line progression event or death due to any cause, up to 34 months
Progression-free Survival (PFS) as assessed by a Blinded Independent Central Review (BICR), per RECIST v1.1
Time frame: From randomization until disease progression (PD) or death, whichever occurs first (up to 34 months)
EuroQol-5 Dimensions-5 Levels Quality of Life Questionnaire (EQ-5D-5L)
EQ-5D-5L is a generic questionnaire that assesses health status as perceived by the patient across 5 categories (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and overall.
Time frame: From baseline and at specified timepoints up to 34 months
Showing the first 100 of 191 sites across 17 countries.
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Karyopharm Therapeutics Inc