Maintenance With Selinexor/Placebo After Combination Chemotherapy in 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:

Patients 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 to selinexor or placebo until disease progression.

Trial Description

Primary Outcome:

• Progression Free Survival (PFS)

• PFS, as assessed by a 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 consecutive treatment (PFS2)
• Time to Second Subsequent Treatment (TSST)
• Disease Control Rate (DCR)
• Health-Related Quality of Life (HR-QoL) as measured by EORTC QLQ30
• Health-Related Quality of Life (HR-QoL) as measured by EORTC QLQ-EN24

View this trial on ClinicalTrials.gov