biostudies-literatureGounder MMNCATS NIH HHSNCI NIH HHS2479-2490https://www.ebi.ac.uk/biostudies/studies/S-EPMC9467680biostudies-literatureUnknown40(22)<h4>Purpose</h4>Antitumor activity in preclinical models and a phase I study of patients with dedifferentiated liposarcoma (DD-LPS) was observed with selinexor. We evaluated the clinical benefit of selinexor in patients with previously treated DD-LPS whose sarcoma progressed on approved agents.<h4>Methods</h4>SEAL was a phase II-III, multicenter, randomized, double-blind, placebo-controlled study. Patients age 12 years or older with advanced DD-LPS who had received two-five lines of therapy were randomly assigned (2:1) to selinexor (60 mg) or placebo twice weekly in 6-week cycles (crossover permitted). The primary end point was progression-free survival (PFS). Patients who received at least one dose of study treatment were included for safety analysis (ClinicalTrials.gov identifier: NCT026Journal of clinical oncology : official journal of the American Society of Clinical OncologySelinexor in Advanced, Metastatic Dedifferentiated Liposarcoma: A Multinational, Randomized, Double-Blind, Placebo-Controlled Trial.PMC9467680P30 CA008748UL1 TR001863Jones RLDickson MAStacchiotti SPenel NKauffman MGHatcher HBeveridge RDBen-Shahar OHartner LForscher CBurgess MBadalamenti GMulcahy MFElias AGonzalez AEChmielowski BVan Tine BAMeyer CNapolitano ALoggers ETShah JJKasper BVincenzi BSchwartz GKDuffaud FMichel DLi LNicholas GRyan CYakobson AAttia SBlay JYGounder MMEriksson MSomaiah NRazak AAPiperno-Neumann SChevreau CLiu JGanjoo KNHerraez ACMazzeo FLapeire LAlcindor TChen JLGroschel SZick ALee ALe Cesne ARiedel RFMartin-Broto JGarcia Del Muro XGotze KChang HChawla SPhilip TWagner AJvon Mehren MDavis EJReichardt PGrignani GOkuno SLandesman YItaliano AShacham SValverde Morales CMSchuetze SMMeng CVan Domelen DRDeshpande HWalker CJfalseSelinexor in Advanced, Metastatic Dedifferentiated Liposarcoma: A Multinational, Randomized, Double-Blind, Placebo-Controlled Trial.<h4>Purpose</h4>Antitumor activity in preclinical models and a phase I study of patients with dedifferentiated liposarcoma (DD-LPS) was observed with selinexor. We evaluated the clinical benefit of selinexor in patients with previously treated DD-LPS whose sarcoma progressed on approved agents.<h4>Methods</h4>SEAL was a phase II-III, multicenter, randomized, double-blind, placebo-controlled study. Patients age 12 years or older with advanced DD-LPS who had received two-five lines of therapy were randomly assigned (2:1) to selinexor (60 mg) or placebo twice weekly in 6-week cycles (crossover permitted). The primary end point was progression-free survival (PFS). Patients who received at least one dose of study treatment were included for safety analysis (ClinicalTrials.gov identifier: NCT0262022-01-01T00:00:00Z2022 Aug2025-04-04T23:36:28.837Z2025-02-19T00:44:12.144ZS-EPMC94676803539480010.1200/JCO.21.01829