Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Endometrial Neoplasms

Uterine Neoplasms

Uterine Diseases

Genital Diseases

Genital Neoplasms, Female

Urogenital Neoplasms

Genital Diseases, Female

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Participants will receive fixed dose of selinexor 80 mg (or 60 mg for participants with a body mass index \[BMI\] less than \[\<\] 20 kilogram per meter square \[kg/m\^2\]) oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle.

Participants will receive matching placebo for selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle.

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

Selinexor

Matching placebo for selinexor

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.

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

A Randomized, Double-Blind, Phase 3 Trial of Maintenance With Selinexor/ Placebo After Combination Chemotherapy for Patients With Advanced or Recurrent Endometrial Cancer

Compare progression free survival of the two treatment arms as assessed by the investigator, per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

Time from randomization until documented PD or death due to any cause, whichever occurs first. Documented PD will be based on BICR assessments.

Time from randomization until date of death from endometrial cancer.

Time from randomization until date of death from any cause.

Time from randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first.

Time from randomization until the second documented disease progression or death due to any cause by any cause on any subsequent line of anticancer therapy.

Time from randomization until date of initiation of second therapy after discontinuation of study drug or death, whichever occurs first.

Best response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) among patients with PR as best response to prior chemotherapy.

Patient-reported outcomes will be measured by the EORTC QLQ C30 questionnaire.

Patient-reported outcomes will be measured by the EORTC QLQ-EN24 questionnaire.

Patient-reported outcomes will be measured by the EORTC EQ-5D-5L.

Belgium and Luxembourg Gynaecological Oncology Group

North-Eastern German Society of Gynaecologic Oncology

Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies

Spanish Research Group in Ovarian Cancer

The Central and Eastern European Gynecologic Oncology Group

Israel Society of Gynecologic Oncology

The GOG Foundation, Inc.

Karyopharm Therapeutics Inc

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Participants will receive a fixed dose of selinexor 60 milligrams (mg) oral tablets once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle.

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

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

Matching Placebo for selinexor

Karyopharm Medical Information

Anna Wilbanks

Michael Toboni

Mei Yu

Lyndsay Willmott

Rachel Gray

Carolyn Haunschild

Laura Macias

Milan Sheth

Vanessa Lopez

Krishnansu Tewari

Bela Shah

Jonathan Berek

Julia Rivera Penafiel

John Chan

Michael Wacker

Bradley Corr

Toni Rodriquez

Scott Jordan

Krystal Olivera

Brian Slomovitz

Nina Kimball

Susan Modesitt

Trena Davis

Chelsea Chandler

Laura Lozano

Urszula Sobol

Cynthia Cruz Rivera

Michael Callahan

Amie Lake

LaToya Perry

Tammy Hines

Sobia Ozair

Cambri Moeller

Tara Castellano

Carrie Kay

Destin Black

Jill Marshall

Sarah Paraghamian

Allison Wolgast

Radhika Gogoi

Khadijra Lockwood

Christen Haygood

Megan Werner

Kristopher (Shawn) LyBarger

Jacky Amador

Nicola M Spirtos

Shannon Pierpoint

Peter Lim

Nicolina Suriano

Joyce Barlin

Karen Estok

Bhavana Pothuri

Neha Kumarley

Monica Prasad

Keith Kallas

Jennifer Mewshaw

Angeles A. Secord

Cara King

Amanda Jackson

Nancy Zangmeister

Emily Whitman-Purves

Kendra Mann

Natalie Walkup

Christine Pappaterra

Debra Richardson

Nora Auston

Christopher Darus

Siobhan Guyach

Sarah Crafton

Teri Kayl

David Starks

Kimberly Donelson

Stephen DePasquale

Amy Lange

Todd Tillmanns

Krissy Bolig

Larry Kilgore

Dominique Marquez

Brandon Sawyer

Annette Paulsen

David Miller

Jaya Kamath

Pedro Ramirez

Ben Singh

Antonio Santillan

Taryn Davis

Christine Lee

Angela Jennings

Anna Priebe

Rachel Lacy

Linda Duska

Claire Kostechka

Ellen Hartenbach

Paul Subarna

Elizabeth Hopp

Jacqui McBurnie

Christopher Steer

Jacquie Harvey

Michelle Harrison

Richard Clayton

Craig Kukard

Julie Charlton

Janine Lombard

Meenal Rai

Bo Gao

Monica Reay

Michael Slancar

Elizabeth Ratcliffe

Baskhar Karki

Holly Price

Allison Black

Karen Lim

Geraldine Goss

Karen Gillett

Kate Webber

Judi Clarke

Yoland Antill

Koby Scarff

Gary Richardson

Marian Lieschke

Linda Mileshkin

Anne Milton

Sudarsha Selva-Nayagam

Florence Fontaine

Jean-Francois Baurain

Sarah Van Damme

Daphne Serruys

Lauren van den Eynde

Toon Van Gorp

Marianne Blockmans

Nathalie Cornez

Benedicte Hyernaux

Stephanie Henry

Alison Avery

Katharina Kieser

Nithla Mohanathas

Al Covens

Bonny Choy

Vanessa Samouëlian

Nathalie Nguyen-Phuong-Nam

Lucy Gilbert

Katerina Polanska

Vit Weinberger

Katerina Havlikova

Klaudia Reginacova

Mamuka Sikharulidze

Tamta Makharadze

Nino Kapanadze

Dina Kurdiani

Aleksandre Iovashivili

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Maintenance With Selinexor/Placebo After Combination Chemotherapy in Participants With Endometrial Cancer [SIENDO]	NCT03555422	Endometrial Can...	Selinexor Matching placeb...	18 Years -	Karyopharm Therapeutics Inc
Maintenance With Selinexor/Placebo After Combination Chemotherapy in Participants With Endometrial Cancer [SIENDO]	NCT03555422	Endometrial Can...	Selinexor Matching placeb...	18 Years -	Karyopharm Therapeutics Inc
Maintenance With Selinexor/Placebo After Combination Chemotherapy in Participants With Endometrial Cancer [SIENDO]	NCT03555422	Endometrial Can...	Selinexor Matching placeb...	18 Years -	Karyopharm Therapeutics Inc
Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma	NCT05611931	Endometrial Can...	Selinexor Matching Placeb...	18 Years -	Karyopharm Therapeutics Inc

Spots Global Cancer Trial Database for matching placebo for selinexor