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

Official Title

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

Summary:

This is a prospective, multicentre, 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.

Trial Description

Primary Outcome:

• Progression Free Survival (PFS)

• Progression Free Survival: Assessed by Blinded Independent Central Review (BICR), per RECIST v1.1
• Disease Specific Survival (DSS)
• Overall Survival (OS)
• Time to First Subsequent Treatment (TFST)
• Progression-free Survival After Subsequent Treatment (PFS2)
• Time to Second Subsequent Treatment (TSST)
• Disease Control Rate (DCR)
• Health-Related Quality of Life (HR-QoL): Measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30
• Health-Related Quality of Life: Measured by EORTC QLQ-EN24
• Health-Related Quality of Life: Measured by EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
• Number of Participants with Treatment Emergent Adverse Events (TEAEs), Occurrence, Nature, and Severity of AEs
• Number of Participants with Significant Physical Examination, Clinical Laboratory, and Vital Signs Results

View this trial on ClinicalTrials.gov