Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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 NGSHistologically confirmed EC including endometrioid, serous, undifferentiated, and carcinosarcoma - 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
Double blind placebo-controlled study

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Selinexor 		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
    Dose: 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral
    Other names:
    • KPT-330
Placebo Comparator
Placebo 		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

Recruiting Locations

The University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764 35205
Contact:
Anna Wilbanks
annaburton@uabmc.edu

More Details

Status
Recruiting
Sponsor
Karyopharm Therapeutics Inc

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.