endometrial cancer
Conditions
Brief summary
The primary endpoint for this study is Progression Free Survival (PFS), which is defined as the time from randomization until documented PD or death due to any cause, whichever occurs first. For the primary analysis of the primary endpoint, documented PD will be determined by the Investigator using RECIST v1.1.
Detailed description
PFS, as assessed by a BICR, per RECIST v1.1, Time to first subsequent therapy (TFST) and time to second subsequent treatment (TSST)., Progression-free survival (PFS2), Disease-specific survival (DSS) and overall survival (OS), Disease-control rate (DCR; defined as best response of CR, PR, or SD for at least 16 weeks)., European Organisation for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire (QLQ)-C30 and EORTC QLQ-EN24., The safety and tolerability of study treatment will be evaluated based on AE reports, physical examination results (including vital signs), and clinical laboratory results by means of the occurrence, nature and severity of AEs.
Interventions
DRUGSELINEXOR
DRUGSelinexor placebo for 20 mg tablets is formulated for oral administration. selinexor placebo tablets are film coated bi-convex round tablets
Sponsors
Karyopharm Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for this study is Progression Free Survival (PFS), which is defined as the time from randomization until documented PD or death due to any cause, whichever occurs first. For the primary analysis of the primary endpoint, documented PD will be determined by the Investigator using RECIST v1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS, as assessed by a BICR, per RECIST v1.1, Time to first subsequent therapy (TFST) and time to second subsequent treatment (TSST)., Progression-free survival (PFS2), Disease-specific survival (DSS) and overall survival (OS), Disease-control rate (DCR; defined as best response of CR, PR, or SD for at least 16 weeks)., European Organisation for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire (QLQ)-C30 and EORTC QLQ-EN24., The safety and tolerability of study treatment will be evaluated based on AE reports, physical examination results (including vital signs), and clinical laboratory results by means of the occurrence, nature and severity of AEs. | — |
Countries
Belgium, Czechia, Germany, Greece, Italy, Spain
Outcome results
None listed