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Selinexor Maintenance Therapy for Endometrial Cancer (ENGOT-EN5 Trial)

Phase 3
Waitlist Available
Research Sponsored by Karyopharm Therapeutics Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Completed a single line of at least 12 weeks of taxane-platinum combination therapy and achieved partial remission (PR) or complete remission (CR) according to RECIST version 1.1 for specific disease stages
Must be able to initiate study drug 5 to 8 weeks after completion of their final dose of chemotherapy
Must not have
Previous treatment with an exportin 1 (XPO1) inhibitor
Major injuries or surgery within 14 days prior to C1D1 and/or planned surgery during the on-treatment study period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 12 weeks during study period, at pd and post pd at 3 and 6 months (approximately 12 months after the last participant enrolled)
Awards & highlights
Pivotal Trial

Summary

This trial is testing if selinexor can help treat endometrial cancer that has progressed or come back after initial treatment.

Who is the study for?
This trial is for women aged 18+ with advanced or recurrent endometrial cancer who've responded to taxane-platinum chemotherapy. They must have good performance status, adequate organ function, and not be pregnant or breastfeeding. Exclusions include previous treatment with certain inhibitors or immunotherapies, recent transfusions, major surgeries, other active cancers (except some skin cancers), uncontrolled infections, and inability to swallow tablets.
What is being tested?
The SIENDO trial tests if selinexor works as a maintenance therapy after initial successful chemotherapy in patients with endometrial cancer. Participants are randomly assigned in a 2:1 ratio to receive either selinexor (80 mg weekly) or a placebo until their disease progresses.
What are the potential side effects?
Selinexor may cause side effects like nausea, vomiting, fatigue, loss of appetite, weight loss, diarrhea or constipation. It can also affect blood counts leading to anemia and increase the risk of infections due to low white blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I completed a specific cancer treatment and my cancer partially or completely responded.
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I can start the study drug 5-8 weeks after my last chemotherapy dose.
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I am fully active or can carry out light work.
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I am a woman and at least 18 years old.
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My cancer is a specific type of endometrial cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with an XPO1 inhibitor before.
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I haven't had major surgery or injuries in the last 14 days and don't plan any during the study.
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I have no known allergies or adverse reactions to selinexor.
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My heart condition is unstable.
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I am not pregnant or breastfeeding.
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I haven't needed IV drugs for an infection in the last week.
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I cannot swallow pills or have a condition that affects how my body absorbs medication.
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I have active cancer spread to my brain.
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I am currently receiving treatment for cancer.
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My cancer is a type of sarcoma, small cell, or clear cell carcinoma.
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I have been treated with PD-1 or PD-L1 immunotherapy before.
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I haven't had cancer treatment or radiation in the last 3 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 12 weeks during study period, at pd and post pd at 3 and 6 months (approximately 12 months after the last participant enrolled)
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 12 weeks during study period, at pd and post pd at 3 and 6 months (approximately 12 months after the last participant enrolled) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival (PFS)
Secondary study objectives
Disease Control Rate (DCR)
Disease Specific Survival (DSS)
Health-Related Quality of Life (HR-QoL): Measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30
+7 more

Side effects data

From 2022 Phase 3 trial • 402 Patients • NCT03110562
43%
Weight decreased
29%
Cough
29%
Thrombocytopenia
29%
Decreased appetite
29%
Nausea
21%
Fatigue
21%
Anaemia
21%
Constipation
21%
Diarrhoea
14%
Neuropathy peripheral
14%
Oedema peripheral
14%
Pneumonia
14%
Paraesthesia
14%
Cataract
14%
Vomiting
14%
Headache
7%
Bronchiectasis
7%
Disturbance in attention
7%
Respiratory syncytial virus infection
7%
Neutropenia
7%
Lower respiratory tract infection
7%
Peripheral swelling
7%
Mental status changes
7%
Basal cell carcinoma
7%
Oropharyngeal pain
7%
Asthma
7%
Back pain
7%
Pain in extremity
7%
Fungal skin infection
7%
Skin lesion
7%
Pyrexia
7%
Upper respiratory tract infection
7%
Nasopharyngitis
7%
Cardiac failure
7%
Hyperthyroidism
7%
Hepatitis
7%
Pharyngitis
7%
Hypophagia
7%
Pollakiuria
7%
Hyponatraemia
7%
Urinary tract infection
7%
Non-cardiac chest pain
7%
C-reactive protein increased
7%
Taste disorder
7%
Haemorrhagic transformation stroke
7%
Abdominal pain
7%
Insomnia
7%
Dyspepsia
7%
Haemoglobin decreased
7%
Infection
7%
Hyperglycaemia
7%
Toothache
7%
Ecchymosis
7%
Hypertension
7%
Viral infection
7%
Muscular weakness
100%
80%
60%
40%
20%
0%
Study treatment Arm
SdX Arm: Selinexor + Dexamethasone
SVdX Arm: Selinexor + Bortezomib + Dexamethasone
SVd Arm: Selinexor + Bortezomib + Dexamethasone
Vd Arm: Bortezomib + Dexamethasone

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SelinexorExperimental Treatment1 Intervention
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.
Group II: Matching placebo for selinexorPlacebo Group1 Intervention
Participants will receive matching placebo for selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
2020
Completed Phase 3
~1730

Find a Location

Who is running the clinical trial?

Israeli Society of Gynecologic OncologyOTHER
3 Previous Clinical Trials
881 Total Patients Enrolled
2 Trials studying Endometrial Cancer
464 Patients Enrolled for Endometrial Cancer
GOG FoundationNETWORK
46 Previous Clinical Trials
17,467 Total Patients Enrolled
6 Trials studying Endometrial Cancer
2,044 Patients Enrolled for Endometrial Cancer
Spanish Research Group in Ovarian CancerUNKNOWN
1 Previous Clinical Trials
220 Total Patients Enrolled
1 Trials studying Endometrial Cancer
220 Patients Enrolled for Endometrial Cancer

Media Library

Selinexor Clinical Trial Eligibility Overview. Trial Name: NCT03555422 — Phase 3
Endometrial Cancer Research Study Groups: Selinexor, Matching placebo for selinexor
Endometrial Cancer Clinical Trial 2023: Selinexor Highlights & Side Effects. Trial Name: NCT03555422 — Phase 3
Selinexor 2023 Treatment Timeline for Medical Study. Trial Name: NCT03555422 — Phase 3
~34 spots leftby Oct 2025
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