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Endometrial CancerPhase 3ENGOT-EN5NCT03555422

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

A Phase 3 study testing Selinexor in people with Endometrial Cancer, run by Karyopharm Therapeutics Inc at 78 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
Selinexor
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
263 participants
Where
78 sitesin 10 countries
Study dates
5 Jan 2018to 3 Apr 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

78 sites in 10 countries.

78 sites in 10 countries

United States19 sites

  • Texas Oncology, Austin

    Austin, Texas, 78731

  • Texas Oncology DFW

    Dallas, Texas, 75246

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Oncology Associates of Oregon

    Eugene, Oregon, 97401

  • Parkview Research Center

    Fort Wayne, Indiana, 46845

  • Texas Oncology DFW

    Fort Worth, Texas, 76104

  • Indiana University Simon Cancer Center

    Indianapolis, Indiana, 46202

  • HCA Midwest Health - Kansas City (Sarah Cannon Research Institute)

    Kansas City, Missouri, 64132

  • Tennessee Oncology Nashville (Sarah Cannon Research Institute)

    Nashville, Tennessee, 37203

  • NYU Langone

    New York, New York, 10016

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Gynecological Cancer Institute of Chicago

    Oak Lawn, Illinois, 60453

  • University of Oklahoma Health Sciences Center - Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Stanford University

    Palo Alto, California, 94304

  • Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905

  • VCU Massey Cancer Center

    Richmond, Virginia, 23298

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Arizona Oncology

    Tucson, Arizona, 85711

  • Florida Cancer Specialists (Sarah Cannon Research Institute)

    West Palm Beach, Florida, 33401

Other trials in United States

Spain14 sites

  • Hospital Universitari Vall d' Hebrón

    Barcelona, 08035

  • Hospital Universitari Clínic de Barcelona

    Barcelona, 08036

  • Consorci Sanitari de Terrassa

    Barcelona, 08227

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Madrid, 28220

  • Hospital Universitario Infanta Sofía

    Madrid, 28702

  • Virgen de la Arrixaca University Clinical Hospital

    Murcia, 30120

  • Hospital Son Llàtzer

    Palma, 071998

  • Hospital Universitario Donostia

    San Sebastián, Gipuzkoa, 20014

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Instituto Valenciano de Oncología

    Valencia, 46009

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitario y Politécnico de La Fe

    Valencia, 46026

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

China8 sites

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • Hunan Cancer Hospital

    Changsha, Hunan

  • Chongqing University Cancer Hospital

    Chongqing, Shapingba District, 400000

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150040

  • Jiangxi Maternal and Child Health Hospital

    Nanchang, Jiangxi, 330006

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110042

  • Wenzhou Medical University - The First Affiliated Hospital

    Wenzhou, Zhejiang, 325000

  • Henan Cancer Hospital

    Zhengzhou, Henan

Other trials in China

Germany8 sites

  • Charite Berlin Universitatsmedizin

    Berlin, 13353

  • University Hospital Dresden

    Dresden, 01307

  • DIAKOVERE KH gGmbH, Henriettenstift Hannover

    Hanover, 30171

  • Universitatsklinikum Schleswig-Holstein

    Kiel, 24105

  • Universitätsfrauenklinik Mainz

    Mainz, 55131

  • Klinikum der Universitat Munchen

    Munich, 80337

  • Cartitas Klinikum Saarbrücken

    Saarbrücken, 66113

  • Universitätsfrauenklinik Ulm

    Ulm, 89070

Other trials in Germany

Italy7 sites

  • Istituto di Candiolo, FPO, IRCCS

    Candiolo, 10060

  • Romagnolo Scientific Institute for the Study and Treatment of Tumors

    Meldola, 47014

  • San Raffaele Hospital

    Milan, 20132

  • Istituto Nazionale dei Tumori IRCCS - MILANO S.C. Ginecologia Oncologica

    Milan, 20133

  • ULSS 3 SERENISSIMA UOC Oncologia Ed Ematologia Oncologica

    Mirano, 30174

  • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" - NAPOLI Struttura Complessa Oncologia Medica Uro-Ginecologica

    Naples, 80131

  • Agostino Gemelli University Polyclinic Foundation

    Rome, 30161

Other trials in Italy

Belgium6 sites

  • UZ Gent

    Ghent, 9000

  • Jan Yperman Ziekenhuis

    Ieper, 8900

  • Universitaire Ziekenhuizen K.U. Leuven

    Leuven, 3000

  • CHU UCL Namur, Site Sainte-Elisabeth

    Namur, 5000

  • AZ Turnhout

    Turnhout, 2300

  • CHR Verviers

    Verviers, 4800

Other trials in Belgium

Czechia5 sites

  • University Hospital Brno

    Brno, 60200

  • University Hospital Ostrava

    Ostrava, 70852

  • UH Královské Vinohrady

    Prague, 10034

  • General University Hospital in Prague

    Prague, 12851

  • Hospital Na Bulovce

    Prague, 18081

Other trials in Czechia

Israel5 sites

  • Hillel Yaffe Medical Center

    Hadera, 38100

  • Wolfson Medical Center

    Holon, 58100

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Hadassah Medical Center

    Jerusalem, 9112001

  • Sheba Medical Center

    Ramat Gan, 52621

Other trials in Israel

Canada3 sites

  • London Health Sciences Centre (London Regional Cancer Centre)

    London, Ontario, N6C 0A7

  • McGill University Health Centre (MUHC)

    Montreal, Quebec, H4A 3J1

  • University Health Network (PMCC)

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Greece3 sites

  • ALEXANDRA Hospital

    Athens, Greece, 11528

  • Iaso Hospital

    Marousi, Athens, 151 23

  • Euromedica General Clinic

    Thessaloniki, Macedonia, 54645

Other trials in Greece

About this study

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

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.

Being tested
Selinexor, Matching placebo for selinexor
Keywords
Endometrial Neoplasms, Uterine Neoplasms, Genital Neoplasms, Neoplasms by Site, Neoplasms, Uterine Diseases, Genital Diseases, Female
Medical subject headings
Endometrial Neoplasms, Uterine Neoplasms, Neoplasms by Site, Neoplasms, Uterine Diseases, Genital Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SelinexorDrug

    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

  • Matching placebo for selinexorDrug

    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

Study groups in NCT03555422
Study groupRoleWhat they receive
SelinexorExperimentalParticipants 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.
Receives: Drug: Selinexor
Matching placebo for selinexorPlacebo comparatorParticipants will receive matching placebo for selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle.
Receives: Drug: Matching placebo for selinexor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    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.

    Measured: Time from randomization until disease progression (PD) or death, whichever occurs first (approximately 12 months after the last participant enrolled)

Secondary outcomes (12)

  1. Progression Free Survival: Assessed by Blinded Independent Central Review (BICR), per RECIST v1.1

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

    Measured: Time from randomization until PD or death, whichever occurs first (approximately 12 months after the last participant enrolled)

  2. Disease Specific Survival (DSS)

    Time from randomization until date of death from endometrial cancer.

    Measured: Time from randomization until death from endometrial cancer (approximately 12 months after the last participant enrolled)

  3. Overall Survival (OS)

    Time from randomization until date of death from any cause.

    Measured: Time from randomization until death (approximately 12 months after the last participant enrolled)

  4. Time to First Subsequent Treatment (TFST)

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

    Measured: Time from randomization until first therapy initiation after discontinuation of study drug or death, whichever occurs first (approximately 12 months after the last participant enrolled)

  5. Progression-free Survival After Subsequent Treatment (PFS2)

    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.

    Measured: Time from randomization until second documented PD or death (approximately 12 months after the last participant enrolled)

  6. Time to Second Subsequent Treatment (TSST)

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

    Measured: Time from randomization until second therapy initiation after discontinuation of study drug or death, whichever occurs first (approximately 12 months after the last participant enrolled)

  7. Disease Control Rate (DCR)

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

    Measured: Time from randomization up to approximately 16 weeks

  8. Health-Related Quality of Life (HR-QoL): Measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30

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

    Measured: Every 12 weeks during study period, at PD and post PD at 3 and 6 months (approximately 12 months after the last participant enrolled)

  9. Health-Related Quality of Life: Measured by EORTC QLQ-EN24

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

    Measured: Every 12 weeks during study period, at PD and post PD at 3 and 6 months (approximately 12 months after the last participant enrolled)

  10. Health-Related Quality of Life: Measured by EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)

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

    Measured: Every 12 weeks during study period, at PD and post PD at 3 and 6 months (approximately 12 months after the last participant enrolled)

  11. Number of Participants with Treatment Emergent Adverse Events (TEAEs), Occurrence, Nature, and Severity of AEs

    Measured: From first drug administration up to 30 days after last dose (approximately 12 months after the last patient enrolled)

  12. Number of Participants with Significant Physical Examination, Clinical Laboratory, and Vital Signs Results

    Measured: From first drug administration up to 30 days after last dose (approximately 12 months after the last patient enrolled)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2018
  2. Study start5 Jan 2018
  3. Primary completion22 Jan 2022
  4. Study completion3 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
263 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03555422
Sponsor's protocol ID
KCP-330-024
Other IDs
ENGOT-EN5, BGOG-EN5, 2017-000607-25, 2017
Acronym
ENGOT-EN5
Status last verified
Apr 2026
First submitted
18 May 2018
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Vergote I, Perez-Fidalgo JA, Hamilton EP, Valabrega G, Van Gorp T, Sehouli J, Cibula D, Levy T, Welch S, Richardson DL, Guerra EM, Scambia G, Henry S, Wimberger P, Miller DS, Klat J, Martinez-Garcia J, Raspagliesi F, Pothuri B, Romero I, Bergamini A, Slomovitz B, Schochter F, Hogdall E, Farinas-Madrid L, Monk BJ, Michel D, Kauffman MG, Shacham S, Mirza MR, Makker V; ENGOT-EN5/GOG-3055/SIENDO Investigators. Oral Selinexor as Maintenance Therapy After First-Line Chemotherapy for Advanced or Recurrent Endometrial Cancer. J Clin Oncol. 2023 Dec 10;41(35):5400-5410. doi: 10.1200/JCO.22.02906. Epub 2023 Sep 5.

    PubMed 37669480

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Selinexor in people with Endometrial Cancer, run by Karyopharm Therapeutics Inc at 78 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, Spain, China, Germany, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Time from randomization until disease progression (PD) or death, whichever occurs first (approximately 12 months after the last participant enrolled)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03555422, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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