Clareo Health | Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma
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Keep this study
Lead
Karyopharm Therapeutics Inc
With
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Belgian Gynaecological Oncology Group
North Eastern German Society of Gynaecological Oncology
The Central and Eastern European Gynecologic Oncology Group
Israeli Society of Gynecologic Oncology
Australia New Zealand Gynaecological Oncology Group
Multicenter Italian Trials in Ovarian Cancer (MITO)
Grupo Español de Investigación en Cáncer de Ovario
Hellenic Cooperative Oncology Group
Cancer Trials Ireland (CTI)
Mario Negri Gynecologic Oncology group (MaNGO)
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adults (Aged ≥ 18 years)
Histologically confirmed endometrial cancer (endometrioid, serous, undifferentiated, or carcinosarcoma sub-types) that is TP53 wild type by central NGS
Must have completed at least 12 weeks of platinum-based chemotherapy (with or without immune checkpoint inhibitors), with a confirmed partial or complete response according to RECIST v1.1
Must be able to initiate C1D1 within 3-8 weeks after last platinum dose
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate bone marrow function and organ function
You may not be if
Uterine sarcomas, clear cell or small cell carcinoma with neuroendocrine differentiation
Palliative radiotherapy administered within 14 days of intended C1D1
Any gastrointestinal dysfunction that could interfere with the absorption of oral study therapy
Serious psychiatric or medical conditions that could interfere with study participation or would make study involvement unreasonably hazardous
Previous treatment with an XPO1 inhibitor
Stable disease or disease progression after platinum-based chemotherapy
Pregnancy, breastfeeding, or other legal/ethical restrictions to trial participation
Known dMMR/MSI-H EC tumors that are medically eligible to receive an immune checkpoint inhibitor
