Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma
A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma
Sponsor: Karyopharm Therapeutics Inc + GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT)
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Investigator assessed Progression Free Survival (PFS) per RECIST v1.1
Time frame: From randomization until disease progression (PD) or death, whichever occurs first (up to 34 months)
Secondary Endpoints
Overall Survival (OS)
Safety and tolerability of study drug (selinexor and placebo)
Time to First Subsequent Therapy (TFST)
Eligibility Criteria
Inclusion Criteria: Patients must meet all of the following inclusion criteria in order to be eligible to participate in this study: * Adults (Aged ≥ 18 years) * Histologically confirmed endometrial cancer (endometrioid, serous, undifferentiated, or carcinosarcoma sub-types) that is TP53 wild type by central NGSHistologically confirmed EC including endometrioid, serous, undifferentiated, and carcinosarcoma * 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 Exclusion Criteria: Patients meeting any of the following exclusion criteria are not eligible to participate in this study: * Uterine sarcomas, clear cell or small cell carcinoma with neuroendocrine …
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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