Treatment
This trial consists of two different treatment options:
- Selinexor
- Placebo
Selinexor and placebo are administered once per week as a tablet.
Patients are assigned randomly to one of the treatment groups.
This trial is a maintenance treatment and will therefore only be administered reaching a PR or CR at the end of chemotherapy.
Treatment duration
Selinexor is administered until disease progression, unacceptable toxicity or withdrawal of consent.
Eligibility
Main inclusion criteria:
- Histologically confirmed endometrioid, serous, undifferentiated or carcinosarcoma of endometrial origin
- TP53 wild-type
- PR or CR after at least 12 weeks platinum-based therapy
- After primary stage IV first-line treatment or after second-line treatment at first relapse
Main exclusion criteria:
- Uterine sarcomas, clear cell or small cell carcinoma with neuroendocrine differentiation
- Blood or platelet transfusion in the 2 weeks prior to Cycle 1 Day 1
- Concurrent systemic steroid therapy >10mg/day prednisone or equivalent
- Recovered from chemotherapy related effects to CTCAE grade 1 or less, except for alopecia
- Gastrointestinal dysfunctions that could interfere with the absorption of Selinexor
Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT05611931). Criteria might change during the course of the study due to amendments. Inclusion in the trial remains the responsibility of the principal investigator of the trial and will depend on patient eligibility and slot availability.
Contact
In case you feel your patient might be eligible for this trial or in case you want to have more information about this trial, please feel free to contact us via: lgog@uzleuven.be