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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
276
Dose: 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral
Dose:60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral
The University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGHonor Health
Phoenix, Arizona, United States
RECRUITINGUniversity of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
RECRUITINGUC DAVIS
Davis, California, United States
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
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City of Hope National Medical Center
Duarte, California, United States
RECRUITINGChao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
WITHDRAWNCity of Hope at Irvine Lennar
Irvine, California, United States
RECRUITINGCancer and Blood Specialty Clinic
Los Alamitos, California, United States
RECRUITINGUCLA - Women's Health Clinical Research Unit
Los Angeles, California, United States
RECRUITINGLong Beach Memorial Medical Center
Los Angeles, California, United States
RECRUITING...and 207 more locations