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Selinexor Maintenance Therapy for Endometrial Cancer (XPORT-EC-042 Trial)
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.
XPORT-EC-042 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2017 Phase 2 trial • 116 Patients • NCT02025985XPORT-EC-042 Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Selinexor
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
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."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Most responsive sites:
- Perlmutter Cancer Center at NYU Langone Health: < 48 hours
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