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

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 276 participants will be enrolled in the study and randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo.

Conditions

• Endometrial Cancer

Interventions

DRUG

Selinexor

Dose: 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral

DRUG

Matching Placebo for selinexor

Dose:60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral

Sponsors & Collaborators

• GOG Foundation

  collaborator NETWORK

• European Network of Gynaecological Oncological Trial Groups (ENGOT)

  collaborator OTHER

• Belgian Gynaecological Oncology Group

  collaborator OTHER

• North Eastern German Society of Gynaecological Oncology

  collaborator OTHER

• The Central and Eastern European Gynecologic Oncology Group

  collaborator OTHER

• Israeli Society of Gynecologic Oncology

  collaborator OTHER

• Australia New Zealand Gynaecological Oncology Group

  collaborator OTHER

• Multicenter Italian Trials in Ovarian Cancer (MITO)

  collaborator UNKNOWN

• Grupo Español de Investigación en Cáncer de Ovario

  collaborator OTHER

• Hellenic Cooperative Oncology Group (HeCOG)

  collaborator UNKNOWN

• Cancer Trials Ireland (CTI)

  collaborator UNKNOWN

• Mario Negri Gynecologic Oncology group (MaNGO)

  collaborator OTHER

• Karyopharm Therapeutics Inc

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-18

Primary Completion

2026-08-31

Completion

2028-01-31

FDA Drug

Yes

Countries

• United States
• Australia
• Belgium
• Canada
• Czechia
• Georgia
• Germany
• Greece
• Hungary
• Ireland
• Israel
• Italy
• Slovakia
• South Korea
• Spain
• Taiwan
• Turkey (Türkiye)

Study Locations