NCT05611931

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 276 (estimated)
• Sponsor: Karyopharm Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Selinexor	Dose: 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral
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

Timeline

• Start date: 2023-04-18
• Primary completion: 2026-08-01
• Completion: 2028-01-01
• First posted: 2022-11-10
• Last updated: 2026-02-02

Locations

217 sites across 17 countries: United States, Australia, Belgium, Canada, Czechia, Georgia, Germany, Greece, Hungary, Ireland, Israel, Italy, Slovakia, South Korea, Spain, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study