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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
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

ENGOT-EN5 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.Check my eligibility
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.See study design
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.

ENGOT-EN5 Trial 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.

ENGOT-EN5 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
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
+9 more

Side effects data

From 2017 Phase 2 trial • 116 Patients • NCT02025985
72%
Weight Decreased
68%
Nausea
60%
Fatigue
56%
Anaemia
52%
Thrombocytopenia
48%
Decreased Appetite
44%
Vomiting
44%
Dysgeusia
24%
Dyspnoea
24%
Diarrhoea
24%
Dizziness
24%
Constipation
20%
Insomnia
20%
Asthenia
20%
Vision Blurred
16%
Dysuria
16%
Pyrexia
16%
Back Pain
16%
Pollakiuria
12%
Haematuria
12%
Headache
12%
Nasopharyngitis
12%
Abdominal Pain
12%
Hypokalaemia
12%
Peripheral Sensory Neuropathy
12%
Cough
12%
Musculoskeletal Chest Pain
12%
Hypomagnesaemia
12%
Anxiety
8%
Arthralgia
8%
Device Occlusion
8%
Oedema Peripheral
8%
Urinary Tract Infection
8%
Depression
8%
Abdominal Distension
8%
Abdominal Pain Upper
8%
Malaise
8%
Face Oedema
8%
Hyponatraemia
8%
Paraesthesia
8%
Hallucination
8%
Night Sweats
8%
Hot Flush
8%
Vaginal Haemorrhage
8%
Confusional State
4%
Muscular Weakness
4%
Vertigo
4%
Renal Failure
4%
Lung Infection
4%
Visual Impairment
4%
Ear Discomfort
4%
Dyspepsia
4%
Anal Haemorrhage
4%
Haematemesis
4%
Rectal Haemorrhage
4%
Cystitis Noninfective
4%
Urinary Retention
4%
Stomatitis
4%
Dry Mouth
4%
Hyperglycaemia
4%
Hyperkalaemia
4%
Bronchitis
4%
Pulmonary Embolism
4%
Hypertension
4%
Bacteraemia
4%
Cystitis
4%
Deep Vein Thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW
Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW
Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW
Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW
Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW

ENGOT-EN5 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 2
~1360

Find a Location

Who is running the clinical trial?

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
The Central and Eastern European Gynecologic Oncology GroupOTHER
3 Previous Clinical Trials
734 Total Patients Enrolled
1 Trials studying Endometrial Cancer
220 Patients Enrolled for Endometrial Cancer
Israel Society of Gynecologic OncologyUNKNOWN
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Given that Selinexor has known risks, who should and shouldn't take it?

"Selinexor has received a score of 3 for safety. This is based on the fact that it is a Phase 3 trial, which not only suggests efficacy but also multiple rounds of data supporting safety."

Answered by AI

Is this experiment currently looking for new participants?

"The clinical trial in question was first posted on January 5th, 2018 and has not been actively recruiting patients since October 7th, 2022 according to data found on clinicaltrials.gov. There are presently 343 other trials looking for participants."

Answered by AI

At how many hospitals or research centers is this experiment being conducted?

"40 different hospitals and clinics are running this study presently. If you wish to participate in the trial, it would be best to choose a location near you from the list of 40 sites. Cities with active facilities include Dallas, Pittsburgh, Oklahoma City and many others."

Answered by AI

What is the maximum number of participants for this clinical trial?

"Currently, this trial is not recruiting patients. The listing was first posted on January 5th, 2018 with the most recent update being October 7th, 2022. However, there are presently 294 other studies actively searching for endometrial cancer patients and 49 trials for Selinexor that still need participants."

Answered by AI

Are there other examples of Selinexor being tested in a clinical setting?

"Selinexor was first researched in 2014 at Princess Margaret Cancer Centre. As of now, there are a total of 29 completed clinical trials. Out of these, 49 are still recruiting patients; many in the Dallas area of Texas."

Answered by AI
~26 spots leftby Dec 2024