Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

• Status: Not yet recruiting
• Trial end date: 2025-08-31

Summary

The purpose of this study is to evaluate the efficacy and safety of selinexor as a maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have achieved a partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v 1.1]) after completing at least 12 weeks of platinum-based therapy. A total of 220 participants will be enrolled in the study and randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo.

• Phase: Phase 3

Details

• Lead Sponsor: Karyopharm Therapeutics Inc
• Collaborators: Belgium and Luxembourg Gynaecological Oncology Group; European Network of Gynaecological Oncological Trial; Israel Society of Gynecologic Oncology; 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.