Imlunestrant/Abemaciclib/Selinexor in Ovarian and Endometrial
brief summary
This is a phase 2, interventional treatment trial evaluating imlunestrant, abemaciclib, and selinexor in two separate patient cohorts: low grade serous ovarian cancer and endometrioid endometrial cancer. The study is non-randomized and open-label. Treatment is administered in the outpatient setting, with a 14-day Cycle 0 followed by 28-day treatment cycles.
detailed description
This DF/HCC PI-sponsored interventional phase 2 trial studies the combination of imlunestrant, abemaciclib, and selinexor in gynecologic cancer cohorts defined by disease type. Baseline evaluations are performed within 14 days before protocol therapy starts, while informed consent and baseline imaging must be completed within 30 days before treatment start. Protocol assessments include physical exams, vital signs, ECOG performance status, CBC, serum chemistries, EKGs, radiologic evaluations, tissue collection, and peripheral blood research collection; Cohort 1A also includes CA-125 testing and research biopsy procedures. Radiologic evaluations are performed every 8 weeks after initiation of Cycle 1, and follow-up continues after treatment discontinuation, including survival follow-up every 6 months.
official title
A Phase II Trial of Imlunestrant/Abemaciclib/Selinexor in Low Grade Serous Ovarian Cancer and in Endometrioid Endometrial Cancer