Maintenance With Selinexor/Placebo After Combination Chemotherapy in Participants With Endometrial Cancer [SIENDO]
Status:
Recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
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.
Belgium and Luxembourg Gynaecological Oncology Group Israel Society of Gynecologic Oncology Karyopharm Therapeutics Inc Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies North-Eastern German Society of Gynaecologic Oncology Spanish Research Group in Ovarian Cancer The Central and Eastern European Gynecologic Oncology Group The GOG Foundation, Inc.