About this trial
We want to see if using Selinexor regularly after treating patients with a certain type of endometrial cancer (where the p53 gene is working properly) can help keep the cancer under control and is safe. We’re focusing on patients who have shown a good response to initial treatment.
In simple terms, Selinexor is a drug that helps control the growth of cells by managing troublesome proteins, kind of like a supervisor managing workers in a factory to prevent overproduction.
Patient Profile
- At least 18 years of age at the time of signing informed consent.
- Histologically confirmed EC including: endometrioid, serous, undifferentiated, and carcinosarcoma.
- TP53 wildtype assessed by next generation sequencing (NGS), evaluated by a central vendor.
- 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: Primary Stage IV disease or At first relapse (i.e., relapse after primary therapy including surgery and/or chemotherapy and/or immunotherapy for Stage I-IV disease).
Where’s this trial being run?
Cork University Hospital and St James’s Hospital
Can I join this study / trial?
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.
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QuestionsSummary Data
| Name: | “XPORT” – ENGOT-EN20/GOG-3083/XPORT-EC-042 |
|---|---|
| Number: | 22-08 |
| Full Title: | 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. |
| Principal Investigator: | Dr. Dearbhaile Collins |
|---|---|
| Type: | Collaborative |
| Sponsor: | Karyopharm Therapeutics Inc |
| Recruitment Started: |
Global: April 2023 Ireland: March 2024 |
| Global Recruitment Target: | 220 |
|---|---|
| Ireland Recruitment Target: |