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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 belowSelect...
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.
Select...
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:Select...
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.
Select...
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 weeks3 visits
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)
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)
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 moreSide effects data
From 2022 Phase 3 trial • 402 Patients • NCT0311056243%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with an XPO1 inhibitor before.I have active cancer spread to my brain.I am currently receiving treatment for cancer.I completed a specific cancer treatment and my cancer partially or completely responded.I can start the study drug 5-8 weeks after my last chemotherapy dose.I am fully active or can carry out light work.My recent tests show my organs and bone marrow are working well.I am a woman and at least 18 years old.I agree to use effective birth control during and for 1 week after the study.I received a blood or platelet transfusion in the last 4 weeks.I haven't had major surgery or injuries in the last 14 days and don't plan any during the study.I have no known allergies or adverse reactions to selinexor.I have not had radiation on the cancer spot in the last 3 months.I haven't needed IV drugs for an infection in the last week.I have severe side effects from past cancer treatments, except for hair loss.My heart condition is unstable.I am not pregnant or breastfeeding.I cannot swallow pills or have a condition that affects how my body absorbs medication.I am willing and able to follow the study's requirements.My chemotherapy was paused but I still saw improvement in my cancer.I have been cancer-free from any previous cancer for at least 3 years.My cancer is a specific type of endometrial cancer.I am premenopausal, can become pregnant, and have a negative pregnancy test.My cancer is a type of sarcoma, small cell, or clear cell carcinoma.I have been treated with PD-1 or PD-L1 immunotherapy before.I haven't had cancer treatment or radiation in the last 3 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Selinexor
- Group 2: Matching placebo for selinexor
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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