Additional Relevant Details
SEAL is a multi-center, randomized, double-blind, placebo-controlled Phase 2/3 clinical trial evaluating single-agent oral selinexor in patients with advanced unresectable dedifferentiated liposarcoma. Patients will be randomized to receive either 60mg of selinexor or placebo given twice weekly per six week cycle until progression or intolerability. Fifty patients are expected to be enrolled in the Phase 2 portion of the study, with the potential to increase enrollment in the Phase 3 portion following an interim analysis. The primary endpoint of progression free survival (PFS) was acceptable to the Food and Drug Administration (FDA). Top-line data from the Phase 2 portion of this study are expected in early 2017.