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

Trial ID or NCT#

NCT05611931

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

Eligibility Criteria

Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

Investigator(s)

Jonathan S Berek
Jonathan S Berek
Gynecologic oncologist
Laurie Kraus Lacob Professor

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Contact

Bela Shah
650-723-0594