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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 up to 34 months
Awards & highlights
XPORT-EC-042 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.Check my eligibility
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.See study design
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.
XPORT-EC-042 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 34 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 34 months
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) Assessed by Investigator as per RECIST v1.1
Secondary outcome measures
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Number of Participants With Severity of Adverse Event According to Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0
Number of Participants with Clinically Significant Changes in Clinical Laboratory Values, Vital Signs and Physical Examination Reported as an Adverse Event
+6 moreSide effects data
From 2017 Phase 2 trial • 116 Patients • NCT0202598578%
Decreased Appetite
65%
Fatigue
65%
Nausea
61%
Vomiting
57%
Weight Decreased
48%
Anaemia
43%
Thrombocytopenia
35%
Hypokalaemia
35%
Vision Blurred
30%
Asthenia
30%
Diarrhoea
26%
Constipation
22%
Dizziness
22%
Dysgeusia
22%
Hyponatraemia
22%
Hypomagnesaemia
17%
Dehydration
17%
Peripheral Sensory Neuropathy
13%
Malaise
13%
Dyspnoea
13%
Neutropenia
13%
Cystitis
13%
Back Pain
9%
Ear Discomfort
9%
Face Oedema
9%
Oedema Peripheral
9%
Pulmonary Embolism
9%
Syncope
9%
Cough
9%
Confusional State
9%
Auditory Disorder
9%
General Physical Health Deterioration
9%
Deep Vein Thrombosis
9%
Urinary Tract Infection
9%
Hyperglycaemia
9%
Pain In Extremity
9%
Hypotension
9%
Paraesthesia
4%
Infection
4%
Visual Impairment
4%
Insomnia
4%
Pneumonia
4%
Cataract
4%
Varicella Zoster Virus Infection
4%
Oropharyngeal Pain
4%
Vertigo
4%
Urosepsis
4%
Pyrexia
4%
Supraventricular Tachycardia
4%
Femoral Neck Fracture
4%
Depression
4%
Polyurea
4%
Hot Flush
4%
Headache
4%
Gait Disturbance
4%
Abdominal Pain
4%
Abdominal Distension
4%
Stomatitis
4%
Ascites
4%
Dry Mouth
4%
Abdominal Pain Lower
4%
Oral Candidiasis
4%
Arthralgia
4%
Vaginal Haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW
Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW
Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW
Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW
Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW
XPORT-EC-042 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 2
~1360
Find a Location
Who is running the clinical trial?
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
36 Previous Clinical Trials
17,019 Total Patients Enrolled
3 Trials studying Endometrial Cancer
646 Patients Enrolled for Endometrial Cancer
Israeli Society of Gynecologic OncologyOTHER
2 Previous Clinical Trials
658 Total Patients Enrolled
1 Trials studying Endometrial Cancer
244 Patients Enrolled for Endometrial Cancer
Australia New Zealand Gynaecological Oncology GroupOTHER
13 Previous Clinical Trials
4,212 Total Patients Enrolled
2 Trials studying Endometrial Cancer
1,431 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are being given this medication as part of the testing process?
"That is correct, the listing on clinicaltrials.gov says that this study is still open to new patients. This trial was originally announced on November 1st, 2020 and updated for the last time on November 16th, 2020. The researchers conducting this trial need to recruit 220 individuals from 2 hospitals or clinics."
Answered by AI
Are researchers actively looking for participants for this clinical trial?
"From what is published on clinicaltrials.gov, it seems that this study requires more participants and is currently recruiting. The trial was first announced on November 1st, 20202 and had its most recent update 16 days ago."
Answered by AI
What is the FDA's standing on Selinexor?
"Selinexor has received a score of 3 from our team at Power. This is due to the fact that it is a Phase 3 trial, which implies that while there is data supporting efficacy, multiple rounds of data are necessary to support safety."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
Perlmutter Cancer Center at NYU Langone Health
University of Tennessee Medical Center
Duke Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Email
Most responsive sites:
- Perlmutter Cancer Center at NYU Langone Health: < 48 hours
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