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

Brief description of study

This is a study to test a drug called selinexor for patients with EC (endometrial carcinoma). The drug will be given to patients who have responded well to chemotherapy as maintenance to keep the cancer from relapsing and will be compared to a placebo (inactive drug). Patients will be randomly assigned to receive either the drug (selinexor) or the placebo. The study will look at how well the drug works and how safe it is. Patients will also be asked to provide a sample of their tumor for testing. The study will continue until patients' cancer worsens or they experience side effects that require them to stop taking the drug. The study will collect information about patients' health, including their quality of life, and will also measure the amount of the drug in their blood.


Clinical Study Identifier: s22-01114
Principal Investigator: Bhavana Pothuri.
Other Investigators: Christina Grace Wilson, Leslie R Boyd, Kent Chan, Michelle Diane Swanson Lightfoot, Emeline Mariam Aviki, Jaime Lynn Moyles, Edward A Jimenez, Erin Annette Reese, Fabia Brisard Pierrot, Whitfield B. Growdon, Deanna Gerber, Eva Chalas-Westermann, Caitlin Elizabeth Ryan, Marina Stasenko, Kelly A Levine, Kathleen M Lutz.


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