Selinexor Maintenance Therapy for Endometrial Cancer
(ENGOT-EN5 Trial)

Recruiting in Palo Alto (17 mi)

+111 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Karyopharm Therapeutics Inc

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for women aged 18+ with advanced or recurrent endometrial cancer who've responded to taxane-platinum chemotherapy. They must have good performance status, adequate organ function, and not be pregnant or breastfeeding. Exclusions include previous treatment with certain inhibitors or immunotherapies, recent transfusions, major surgeries, other active cancers (except some skin cancers), uncontrolled infections, and inability to swallow tablets.

Inclusion Criteria

Written informed consent in accordance with federal, local, and institutional guidelines. The participant must provide informed consent prior to the first Screening procedure

I completed a specific cancer treatment and my cancer partially or completely responded.

I can start the study drug 5-8 weeks after my last chemotherapy dose.

+8 more

Exclusion Criteria

Known uncontrolled hypersensitivity to the investigational drug, or to its excipients

I have been treated with an XPO1 inhibitor before.

Concurrent treatment with an investigational agent or participation in another clinical trial

+21 more

Participant Groups

The SIENDO trial tests if selinexor works as a maintenance therapy after initial successful chemotherapy in patients with endometrial cancer. Participants are randomly assigned in a 2:1 ratio to receive either selinexor (80 mg weekly) or a placebo until their disease progresses.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SelinexorExperimental Treatment1 Intervention

Participants will receive fixed dose of selinexor 80 mg (or 60 mg for participants with a body mass index \[BMI\] less than \[\<\] 20 kilogram per meter square \[kg/m\^2\]) oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle.

Group II: Matching placebo for selinexorPlacebo Group1 Intervention

Participants will receive matching placebo for selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle.