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Maintenance With Selinexor/Placebo After Combination Chemotherapy in Participants With Endometrial Cancer [SIENDO]

NCT03555422 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Selinexor

Dose: 80 mg (4 tablets) or 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: 80 mg (4 tablets) or 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral

Sponsors & Collaborators

  • Belgian Gynaecological Oncology Group

    collaborator OTHER

  • The Central and Eastern European Gynecologic Oncology Group

    collaborator OTHER

  • Israeli Society of Gynecologic Oncology

    collaborator OTHER

  • GOG Foundation

    collaborator NETWORK

  • Multicenter Italian Trials in Ovarian Cancer (MITO)

    collaborator UNKNOWN

  • Grupo Español de Investigación en Cáncer de Ovario

    collaborator OTHER

  • North Eastern German Society of Gynaecological Oncology

    collaborator OTHER

  • Karyopharm Therapeutics Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-05
Primary Completion
2022-01-22
Completion
2025-04-03
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • China
  • Czechia
  • Germany
  • Greece
  • Israel
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03555422 on ClinicalTrials.gov