New pill aims to keep endometrial cancer at bay after chemo

NCT ID NCT03555422

Disease control Sponsor: Karyopharm Therapeutics Inc Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested whether taking the drug selinexor as a maintenance pill after chemotherapy can help delay cancer progression in people with advanced or recurrent endometrial cancer. 263 participants who had responded to initial chemo were randomly assigned to receive either selinexor or a placebo. The study is now complete, and researchers are analyzing how long participants remained cancer-free.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: selinexor (a drug taken as a pill)
What this could lead to: If it works, this could offer a new maintenance option to delay cancer progression after initial chemotherapy for advanced or recurrent endometrial cancer.
What could go wrong: This is a completed Phase 3 trial, but results are not yet widely available. Selinexor may cause side effects like nausea, fatigue, or low blood counts, and it may not improve survival for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

263 people

The number who actually took part.

Started

Jan 2018

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Female, at least 18 years of age at the time of informed consent. * Histological confirmed endometrial cancer of the endometrioid, serous, or undifferentiated type. Carcinosarcoma of the uterus is also allowed. * Completed a single line of at least 12 weeks of taxane-platinum combination therapy (not including adjuvant or neoadjuvant therapy), and achieved partial remission (PR) or complete remission (CR) according to RECIST version 1.1 for: * Primary Stage IV disease, defined as: * had a primary or later debulking surgery during first-line taxane-platinum therapy with R0 resection (R0 resection indicates a macroscopic complete resection of all visible tumor) and achieved CR after at least 12 weeks taxane-platinum chemotherapy, OR * had a primary or later debulking surgery during first-line taxane-platinum therapy with R1 resection (R1 resection indicates incomplete removal of all macroscopic disease,) and achieved PR or CR after at least 12 weeks taxane-platinum chemotherapy, OR * had no surgery and achieved PR or CR after at least 12 weeks taxane-platinum chemotherapy. OR * At first relapse (i.e., relapse after primary therapy including surgery and/or chemotherapy therapy for Stage I-IV disease), defined as: * had Stage I-III disease at diagnosis and received at initial diagnosis adjuvant chemotherapy and relapsed later. Participants should have PR or CR after at least 12 weeks of taxane-platinum chemotherapy compared with the start of this chemotherapy at the time of relapse, OR * had Stage I-III disease at diagnosis and did not receive adjuvant chemotherapy at initial diagnosis and relapsed later. Participants should have PR or CR after at least 12 weeks of taxane-platinum chemotherapy compared with the start of this chemotherapy at the time of relapse, OR * had Stage IV disease at diagnosis and received initially chemotherapy with or without surgery and relapsed later. At the time of relapse, participants should have PR or CR after at least 12 weeks of taxane-platinum chemotherapy compared with the start of this chemotherapy at the time of relapse. Participants that required their chemotherapy dose held during the 12-week therapy may be considered if they meet the other criteria above and achieve PR or CR per RECIST V1.1. * Must be able to initiate study drug 5 to 8 weeks after completion of their final dose of chemotherapy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Participants must have adequate bone marrow function and organ function within 2 weeks before starting study drug as defined by the following laboratory criteria: * Hepatic function: total bilirubin up to 1.5\*upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to (≤) 2.5\*ULN in participants without liver metastasis. For participants with known liver involvement of their tumor: AST and ALT ≤5\*ULN. * Hematopoetic function: Absolute neutrophil count (ANC) greater than or equal to (≥) 1.5\*10\^9/L; platelet count ≥100\*10\^9 per liter (/L); hemoglobin ≥9.0 gram per deciliter (g/dL). * Renal function: estimated creatinine clearance (CrCl) of ≥20 milliliter per minute (mL/min), calculated using the Cockroft Gault formula. * In the opinion of the Investigator, the participant must: * Have a life expectancy of at least 12 weeks, and * Be fit to receive experimental therapy. * Premenopausal females of childbearing potential must have a negative pregnancy test (serum β-human chorionic gonadotropin test) prior to the first dose of study drug. Female participants of childbearing potential must agree to use highly effective methods of contraception throughout the study and for 1 week following the last dose of study drug. * Written informed consent in accordance with federal, local, and institutional guidelines. The participant must provide informed consent prior to the first Screening procedure. Exclusion Criteria: * Has any sarcomas, small cell carcinoma with neuroendocrine differentiation, or clear cell carcinomas. * Received a blood or platelet transfusion during 4 weeks prior to randomization. * Being treated with a concurrent cancer therapy. * Previous treatment with an exportin 1 (XPO1) inhibitor. * Previous treatment with anti- programmed cell death protein 1 (PD-1) or anti-programmed cell death ligand-1 (PD-L1) immunotherapy (e.g., pembrolizumab). * Concurrent treatment with an investigational agent or participation in another clinical trial. * Participants who received any systemic anticancer therapy including investigational agents or radiation ≤3 weeks (or ≤5 half-lives of the drug \[whichever is shorter\]) prior to cycle 1 day 1 (C1D1). Palliative radiotherapy may be permitted for symptomatic control of pain from bone metastases in extremities, provided that the radiotherapy does not involve target lesions, and the reason for the radiotherapy does not reflect progressive disease (PD). * Major injuries or surgery within 14 days prior to C1D1 and/or planned surgery during the on-treatment study period. * Previous malignant disease, except participants with other malignant disease, for which the participant has been disease-free for at least 3 years. Concurrent other malignant disease except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin. * Any life-threatening illness, medical condition or organ system dysfunction, which, in the investigator's opinion, could compromise the participant's safety or compliance with the protocol. * Known contraindications to selinexor. * Known uncontrolled hypersensitivity to the investigational drug, or to its excipients. * Radiotherapy to the target lesion within the past 3 months prior to baseline imaging. * Persistent Grade 3 or 4 toxicity from previous chemotherapy and/or radiotherapy, with the exception of alopecia. * Active brain metastases (e.g., stable for \<8 weeks, no adequate previous treatment with radiotherapy and/or surgery, symptomatic, requiring treatment with anti-convulsants. Corticoid therapy is allowed if administered as stable dose for at least 1 month before randomization). * Known unstable cardiovascular function: * Symptomatic ischemia, or * Uncontrolled clinically significant conduction abnormalities (i.e., ventricular tachycardia on anti-arrhythmia are excluded; 1st degree atrioventricular block or asymptomatic left anterior fascicular block /right bundle branch block will not be excluded), or * Congestive heart failure of New York Heart Association Class ≥3, or * Myocardial infarction within 3 months * Females who are pregnant or actively breastfeeding. * Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to first dose; however, prophylactic use of these agents is acceptable even if parenteral. * Active hepatitis C and/or B infection. * Participants unable to swallow tablets, participants with malabsorption syndrome, or any other gastrointestinal (GI) disease or GI dysfunction that could interfere with absorption of study drug. A history of bowel obstruction requiring a nasogastric tube or intravenous infusion during the past 2 months is not allowed (except when this obstruction is caused by surgery or other non-malignant causes). * Psychiatric illness or substance use that would prevent the participant from giving informed consent or being compliant with the study procedures. * Participants unwilling or unable to comply with the protocol. * Persons who have been committed to an institution by official or judicial order. * Participants with dependency on the Sponsor, Investigator or study site.

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Conditions

The condition(s) this trial relates to.

endometrial cancer endometrium neoplasm Genital Diseases neoplasm Neoplasms by Site uterine cancer uterine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endometrial cancer

Contacts and locations

Locations

ALEXANDRA Hospital

Athens, Greece, 11528, Greece
AZ Turnhout

Turnhout, 2300, Belgium
Agostino Gemelli University Polyclinic Foundation

Rome, 30161, Italy
Arizona Oncology

Tucson, Arizona, 85711, United States
CHR Verviers

Verviers, 4800, Belgium
CHU UCL Namur, Site Sainte-Elisabeth

Namur, 5000, Belgium
Cartitas Klinikum Saarbrücken

Saarbrücken, 66113, Germany
Charite Berlin Universitatsmedizin

Berlin, 13353, Germany
Chongqing University Cancer Hospital

Chongqing, Shapingba District, 400000, China
Consorci Sanitari de Terrassa

Barcelona, 08227, Spain
DIAKOVERE KH gGmbH, Henriettenstift Hannover

Hanover, 30171, Germany
Euromedica General Clinic

Thessaloniki, Macedonia, 54645, Greece
Florida Cancer Specialists (Sarah Cannon Research Institute)

West Palm Beach, Florida, 33401, United States
General University Hospital in Prague

Prague, 12851, Czechia
Gynecological Cancer Institute of Chicago

Oak Lawn, Illinois, 60453, United States
HCA Midwest Health - Kansas City (Sarah Cannon Research Institute)

Kansas City, Missouri, 64132, United States
Hadassah Medical Center

Jerusalem, 9112001, Israel
Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150040, China
Henan Cancer Hospital

Zhengzhou, Henan, China
Hillel Yaffe Medical Center

Hadera, 38100, Israel
Hospital Clínico Universitario Lozano Blesa

Zaragoza, 50009, Spain
Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain
Hospital Na Bulovce

Prague, 18081, Czechia
Hospital Son Llàtzer

Palma, 071998, Spain
Hospital Universitari Clínic de Barcelona

Barcelona, 08036, Spain
Hospital Universitari Vall d' Hebrón

Barcelona, 08035, Spain
Hospital Universitario Donostia

San Sebastián, Gipuzkoa, 20014, Spain
Hospital Universitario Infanta Sofía

Madrid, 28702, Spain
Hospital Universitario Puerta de Hierro - Majadahonda

Madrid, 28220, Spain
Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain
Hospital Universitario Virgen del Rocío

Seville, 41013, Spain
Hospital Universitario y Politécnico de La Fe

Valencia, 46026, Spain
Hunan Cancer Hospital

Changsha, Hunan, China
Iaso Hospital

Marousi, Athens, 151 23, Greece
Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States
Instituto Valenciano de Oncología

Valencia, 46009, Spain
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" - NAPOLI Struttura Complessa Oncologia Medica Uro-Ginecologica

Naples, 80131, Italy
Istituto Nazionale dei Tumori IRCCS - MILANO S.C. Ginecologia Oncologica

Milan, 20133, Italy
Istituto di Candiolo, FPO, IRCCS

Candiolo, 10060, Italy
Jan Yperman Ziekenhuis

Ieper, 8900, Belgium
Jiangxi Maternal and Child Health Hospital

Nanchang, Jiangxi, 330006, China
Klinikum der Universitat Munchen

Munich, 80337, Germany
Liaoning Cancer Hospital

Shenyang, Liaoning, 110042, China
London Health Sciences Centre (London Regional Cancer Centre)

London, Ontario, N6C 0A7, Canada
McGill University Health Centre (MUHC)

Montreal, Quebec, H4A 3J1, Canada
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
Moffitt Cancer Center

Tampa, Florida, 33612, United States
NYU Langone

New York, New York, 10016, United States
Oncology Associates of Oregon

Eugene, Oregon, 97401, United States
Parkview Research Center

Fort Wayne, Indiana, 46845, United States
Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China
Romagnolo Scientific Institute for the Study and Treatment of Tumors

Meldola, 47014, Italy
San Raffaele Hospital

Milan, 20132, Italy
Shaare Zedek Medical Center

Jerusalem, 9103102, Israel
Sheba Medical Center

Ramat Gan, 52621, Israel
Stanford University

Palo Alto, California, 94304, United States
Tennessee Oncology Nashville (Sarah Cannon Research Institute)

Nashville, Tennessee, 37203, United States
Texas Oncology DFW

Dallas, Texas, 75246, United States
Texas Oncology DFW

Fort Worth, Texas, 76104, United States
Texas Oncology, Austin

Austin, Texas, 78731, United States
UH Královské Vinohrady

Prague, 10034, Czechia
ULSS 3 SERENISSIMA UOC Oncologia Ed Ematologia Oncologica

Mirano, 30174, Italy
UZ Gent

Ghent, 9000, Belgium
Universitaire Ziekenhuizen K.U. Leuven

Leuven, 3000, Belgium
Universitatsklinikum Schleswig-Holstein

Kiel, 24105, Germany
University Health Network (PMCC)

Toronto, Ontario, M5G 2M9, Canada
University Hospital Brno

Brno, 60200, Czechia
University Hospital Dresden

Dresden, 01307, Germany
University Hospital Ostrava

Ostrava, 70852, Czechia
University of Oklahoma Health Sciences Center - Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States
University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States
Universitätsfrauenklinik Mainz

Mainz, 55131, Germany
Universitätsfrauenklinik Ulm

Ulm, 89070, Germany
VCU Massey Cancer Center

Richmond, Virginia, 23298, United States
Virgen de la Arrixaca University Clinical Hospital

Murcia, 30120, Spain
Wenzhou Medical University - The First Affiliated Hospital

Wenzhou, Zhejiang, 325000, China
Wolfson Medical Center

Holon, 58100, Israel
Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

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