XPORT-EC

ENGOT-EN20/GOG-3083/XPORT-EC-042

“A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicentre Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma”.

Inclusion Criteria:

• At least 18 years of age at the time of signing informed consent.
• Histologically confirmed Endometrial Carcinoma including: endometrioid, serous, undifferentiated, and carcinosarcoma.
• TP53 wildtype
• Completed a single line, at least 12 weeks of platinum-based therapy (not including adjuvant or neoadjuvant therapy for Stage I-III disease) and achieved confirmed partial or complete response (PR or CR) by imaging, according to RECIST version 1.1. The participants should have received treatment for:

Exclusion Criteria:

• Participants meeting any of the following exclusion criteria are not eligible to enroll in this study:
• Has any uterine sarcomas, clear cell or small cell carcinoma with neuroendocrine differentiation
• Received a blood or platelet transfusion during the 2 weeks prior to Cycle 1 Day 1 (C1D1).
• Concurrent systemic steroid therapy higher than physiologic dose.
• Insufficient time since or not recovered from procedures or anti-cancer therapy.
• Having ongoing clinically significant anti-cancer therapy-related toxicities
• Palliative radiotherapy within 14 days of the intended first dose.
• Any gastrointestinal dysfunctions that could interfere with the absorption of Selinexor (as it is an oral medication).
• Participants unable to tolerate two forms of antiemetics for at least 2 cycles.
• Active, ongoing or uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week of screening.
• Serious psychiatric or medical condition that could interfere with participation in the study
• Previous treatment with an XPO1 inhibitor.
• Stable disease or Progressive Disease on the post-chemotherapy scan or clinical evidence of progression prior to randomisation.
• Participants who received any systemic anticancer therapy including investigational agents <= 3 weeks before the first dose.
• Major injuries or surgery within 14 days prior to the first dose and/or planned major surgery during the on-treatment study period.
• Other malignant disease with disease-free <= 3 years except: curatively treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, or ductal carcinoma in situ (DCIS) of the breast.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to selinexor, or other agents used in the study.
• Active brain metastases.
• Females who are pregnant or lactating.
• Any other life-threatening illness, active medical condition, organ system dysfunction, or serious active psychiatric issue which, in the Investigator’s opinion, could compromise the participant’s safety or the participant’s ability to remain compliant with study procedures.

Opened in Ireland February 2024.

Expected Last Patient enrolled March 2025.

The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.