GOG-3083 XPORT-EC-042 SELINEXOR IN MAINTENANCE THERAPY FOR ADVANCED ENDOMETRIAL CANCER

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:
  • Are diagnosed with endometrial cancer of one of the following types: endometrioid, serous, undifferentiated, or carcinosarcoma
  • Have a documented TP53 wild-type mutation
  • Have completed at least 12 weeks of platinum-based therapy that achieved a full or partial response
For more information about this study, please contact the study team at william.s.andrews@duke.edu.

Age Range

18-110

Sex/Genders

Female (cisgender)
Non-binary or gender fluid
Transgender male
Looking for Healthy Participants
No

What is Involved?

Description

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.
  • You will take a fixed dose of the study drug or placebo by mouth once per week.
  • 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.
  • 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.

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
ClinicalTrials.gov