Purpose of this Study
We are doing this study to find out if a drug called selinexor (the study drug) is a safe and effective option for maintenance therapy for patients with TP53 wild-type endometrial cancer who had a positive response to treatment with chemotherapy.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with endometrial cancer of one of the following types: endometrioid, serous, undifferentiated, or carcinosarcoma</li>
<li>Have a documented TP53 wild-type mutation</li>
<li>Have completed at least 12 weeks of platinum-based therapy that achieved a full or partial response</li></ul>
For more information about this study, please contact the study team at <a href= "mailto: william.s.andrews@duke.edu"> william.s.andrews@duke.edu.</a>
<li>Are diagnosed with endometrial cancer of one of the following types: endometrioid, serous, undifferentiated, or carcinosarcoma</li>
<li>Have a documented TP53 wild-type mutation</li>
<li>Have completed at least 12 weeks of platinum-based therapy that achieved a full or partial response</li></ul>
For more information about this study, please contact the study team at <a href= "mailto: william.s.andrews@duke.edu"> william.s.andrews@duke.edu.</a>
Age Range
18-110
Sex/Genders
Female (cisgender)
Non-binary or gender fluid
Transgender male
Looking for Healthy Participants
No
What is Involved?
If you choose to join this study, you will get a random assignment (like a coin flip) to either take the study drug or placebo (an inactive substance that has no medicine in it). The study is "blinded," which means that neither you nor your doctor will know if you are receiving selinexor or placebo.<ul>
<li>You will take a fixed dose of the study drug or placebo by mouth once per week.</li>
<li>During cycle 1, you will need to visit the research center every 2 weeks. From cycle 2 onwards, you will need to visit the research center every 4 weeks. A "cycle" in this study is a 28-day period during which you will take the study drug or placebo.</li>
<li>The number of cycles you do in the study depends on how well you are tolerating the study drug and how well your cancer responds to it.</li></ul>
<li>You will take a fixed dose of the study drug or placebo by mouth once per week.</li>
<li>During cycle 1, you will need to visit the research center every 2 weeks. From cycle 2 onwards, you will need to visit the research center every 4 weeks. A "cycle" in this study is a 28-day period during which you will take the study drug or placebo.</li>
<li>The number of cycles you do in the study depends on how well you are tolerating the study drug and how well your cancer responds to it.</li></ul>
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
ENGOT-EN20/GOG-3083/XPORT-EC-042 A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER TRIAL OF SELINEXOR IN MAINTENANCE THERAPY AFTER SYSTEMIC THERAPY FOR PATIENTS WITH P53WILD-TYPE, ADVANCED OR RECURRENT ENDOMETRIAL CARCINOMA
Principal Investigator
Angeles
Secord
Protocol Number
PRO00112976
NCT ID
NCT05611931
Phase
III
Enrollment Status
Open to Enrollment