NCT03555422

Maintenance With Selinexor/Placebo After Combination Chemotherapy in Participants With Endometrial Cancer [SIENDO]

A Randomized, Double-Blind, Phase 3 Trial of Maintenance With Selinexor/ Placebo After Combination Chemotherapy for Patients With Advanced or Recurrent Endometrial Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 263 (actual)
• Sponsor: Karyopharm Therapeutics Inc · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, double-blind, placebo-controlled, randomized Phase 3 study. The purpose of the study is to obtain evidence of efficacy for maintenance selinexor in participants with advanced or recurrent endometrial cancer. Participants with primary stage IV or recurrent disease who are in partial or complete response after having completed a single line of at least 12 weeks of taxane-platinum combo therapy will be randomized in a 2:1 manner to maintenance therapy with 80 milligram (mg) with selinexor once weekly (QW) or placebo until progression.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Selinexor	Dose: 80 mg (4 tablets) or 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: 80 mg (4 tablets) or 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral

Timeline

• Start date: 2018-01-05
• Primary completion: 2022-01-22
• Completion: 2025-04-03
• First posted: 2018-06-13
• Last updated: 2026-04-13

Locations

78 sites across 10 countries: United States, Belgium, Canada, China, Czechia, Germany, Greece, Israel, Italy, Spain

Regulatory

• FDA-regulated drug study