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Selinexor Maintenance Therapy for Endometrial Cancer (XPORT-EC-042 Trial)
Phase 3
Recruiting
Research Sponsored by Karyopharm Therapeutics Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 34 months
Awards & highlights
Pivotal Trial
Summary
This trial tests a drug, selinexor, as a maintenance therapy for endometrial carcinoma post platinum-based therapy. 220 participants will take part and be randomly assigned to selinexor or placebo.
Who is the study for?
This trial is for adults with advanced or recurrent endometrial carcinoma that's p53 wild-type. They must have responded to platinum-based therapy and be able to start the study drug within 3-8 weeks after chemotherapy. Participants need good organ function, an ECOG status of 0-1, and a life expectancy over 12 weeks. Women who can bear children must test negative for pregnancy and agree to use contraception.
What is being tested?
The trial tests Selinexor as maintenance therapy against a placebo in patients who've had partial or complete response to previous treatment. It aims to see if Selinexor helps keep cancer from coming back or getting worse after initial success with chemotherapy.
What are the potential side effects?
Selinexor may cause nausea, vomiting, diarrhea, fatigue, loss of appetite, weight changes, blood count abnormalities (like low platelets or white cells), electrolyte imbalances and could affect liver enzymes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 34 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 34 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Side effects data
From 2022 Phase 3 trial • 402 Patients • NCT0311056250%
Thrombocytopenia
45%
Anaemia
39%
Nausea
29%
Decreased appetite
29%
Diarrhoea
27%
Weight decreased
24%
Neuropathy peripheral
24%
Vomiting
23%
Fatigue
21%
Neutropenia
21%
Cataract
15%
Asthenia
12%
Upper respiratory tract infection
11%
Pyrexia
11%
Constipation
8%
Oedema peripheral
8%
Pneumonia
6%
Lymphopenia
6%
Dizziness
6%
Insomnia
6%
Dehydration
6%
Back pain
6%
Leukopenia
6%
Bronchitis
6%
Cough
5%
Acute kidney injury
5%
Abdominal pain
5%
Muscular weakness
5%
Lower respiratory tract infection
3%
Pain in extremity
3%
Sepsis
3%
Hyperglycaemia
3%
Urinary tract infection
3%
Nasopharyngitis
3%
Hyponatraemia
3%
Toothache
3%
Disturbance in attention
3%
Cardiac failure
3%
Hypertension
2%
Blood uric acid increased
2%
Cardiac failure acute
2%
Pulmonary contusion
2%
Peripheral swelling
2%
Blood creatinine increased
2%
Paraesthesia
2%
Infection
2%
Respiratory syncytial virus infection
2%
Dyspepsia
2%
Syncope
2%
Clostridium difficile infection
2%
Compression fracture
2%
Multiple fractures
2%
Myocardial infarction
2%
C-reactive protein increased
2%
Cerebral haemorrhage
2%
Ischaemic stroke
2%
Sudden death
2%
Oropharyngeal pain
2%
Cognitive disorder
2%
Confusional state
2%
Influenza
2%
Septic shock
2%
Osteonecrosis of jaw
2%
Taste disorder
2%
Hyperkalaemia
2%
Depression
2%
Cerebrovascular accident
2%
Bronchitis viral
2%
Embolism
2%
Haemoglobin decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
SVdX Arm: Selinexor + Bortezomib + Dexamethasone
SdX Arm: Selinexor + 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 a fixed dose of selinexor 60 milligrams (mg) oral tablets once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle.
Group II: PlaceboPlacebo 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?
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
39 Previous Clinical Trials
17,986 Total Patients Enrolled
4 Trials studying Endometrial Cancer
1,072 Patients Enrolled for Endometrial Cancer
Israeli Society of Gynecologic OncologyOTHER
3 Previous Clinical Trials
924 Total Patients Enrolled
2 Trials studying Endometrial Cancer
507 Patients Enrolled for Endometrial Cancer
Australia New Zealand Gynaecological Oncology GroupOTHER
14 Previous Clinical Trials
4,482 Total Patients Enrolled
2 Trials studying Endometrial Cancer
1,431 Patients Enrolled for Endometrial Cancer
GOG FoundationNETWORK
46 Previous Clinical Trials
17,430 Total Patients Enrolled
6 Trials studying Endometrial Cancer
2,007 Patients Enrolled for Endometrial Cancer
North Eastern German Society of Gynaecological OncologyOTHER
24 Previous Clinical Trials
8,732 Total Patients Enrolled
3 Trials studying Endometrial Cancer
468 Patients Enrolled for Endometrial Cancer
Karyopharm Therapeutics IncLead Sponsor
88 Previous Clinical Trials
7,353 Total Patients Enrolled
1 Trials studying Endometrial Cancer
263 Patients Enrolled for Endometrial Cancer
The GOG Foundation, Inc.UNKNOWN
1 Previous Clinical Trials
263 Total Patients Enrolled
1 Trials studying Endometrial Cancer
263 Patients Enrolled for Endometrial Cancer
European Network of Gynaecological Oncological TrialUNKNOWN
Belgium and Luxembourg Gynaecological Oncology GroupUNKNOWN
1 Previous Clinical Trials
263 Total Patients Enrolled
1 Trials studying Endometrial Cancer
263 Patients Enrolled for Endometrial Cancer
North-Eastern German Society of Gynaecologic OncologyUNKNOWN
1 Previous Clinical Trials
263 Total Patients Enrolled
1 Trials studying Endometrial Cancer
263 Patients Enrolled for Endometrial Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can start the study drug 3-8 weeks after my last chemotherapy dose.I am taking higher than normal doses of steroids.I do not have stomach or bowel problems affecting medicine absorption.I have received palliative radiotherapy within the last 14 days.I have been cancer-free for less than 3 years, except for certain skin, cervical, or breast cancers.I am 18 years old or older.I do not have an active infection requiring IV drugs.I cannot tolerate two types of anti-nausea medication for 2 cycles.I have been treated with an XPO1 inhibitor before.I am not pregnant or breastfeeding.My recent tests show my organs and bone marrow are working well.My cancer is a confirmed type of endometrial cancer.I am fully active or have some restrictions but can still care for myself.I have been treated with PD-1 or PD-L1 inhibitors before.I will use effective birth control during and for 3 months after the study.My cancer is a type of uterine sarcoma, but not carcinosarcoma.My cancer does not have TP53 mutations as tested by advanced methods.My cancer has not worsened or shown signs of progression after my last chemotherapy.I haven't fully recovered from my last cancer treatment or procedure.I received a blood or platelet transfusion within the last 2 weeks.I am premenopausal, can become pregnant, and have a negative pregnancy test.I haven't had major surgery in the last 14 days and don't plan any during the study.I have active cancer spread to my brain.I completed a platinum-based treatment and my cancer responded well, as shown by scans.My liver, blood, and kidney functions meet the study's required levels.I haven't had any cancer treatment or experimental drugs in the last 3 weeks.I have been treated with PD-1 or PD-L1 inhibitors and other biological drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Selinexor
- Group 2: Placebo
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.