A Phase 1 Study to Assess Oral Bioavailability of a Novel Oral Soft Gelatin Capsule Formulation of Rigosertib (ON 01910.Na) Under Fasted and Fed Conditions in Patients with Myelodysplastic Syndromes

Background: Rigosertib (ON 01910.Na) is a novel multikinase inhibitor, with selective cytotoxic effects on tumor cells without impact on normal cells. Rigosertib, administered as a 3-day continuous infusion, is now undergoing phase 3 evaluation in higher risk MDS patients refractory to hypomethylating agents. Here, we report the results of the effect of food on the absolute bioavailability of a novel rigosertib oral formulation (soft gelatin capsule) in MDS patients.