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Selinexor Maintenance Therapy for Endometrial Cancer (ENGOT-EN5 Trial)
ENGOT-EN5 Trial Summary
This trial is testing if selinexor can help treat endometrial cancer that has progressed or come back after initial treatment.
ENGOT-EN5 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowENGOT-EN5 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 • NCT02025985ENGOT-EN5 Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Selinexor
- Group 2: Matching placebo for selinexor
- 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
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."
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."
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."
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."
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."
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