This will be a Phase II open-label, multicenter (up to 5 centers), single-arm study. Sixty transfusion-dependent patients with MDS classified as Low or Int-1 risk (any cytogenetics) or trisomy 8 Int-2 by International Prognostic Scoring System (IPSS) will be enrolled to receive on an outpatient basis 560 mg rigosertib BID for 14 consecutive days of a 21-day cycle. (Note: Protocol was amended to delete the arm in which administration of rigosertib was a continuous regimen on days 1 to 21 of 21-day cycle because higher incidence of urinary symptoms was observed in this arm.) Patients will be stratified on prior treatment with azacitidine and/or decitabine and/or lenalidomide and/or erythropoietin. Patients will remain treated on study until 2006 Internation Working Group (IWG) progression criteria are met or until death from any cause. All study participants will be allowed, as medically justified, access to RBC and platelet transfusions, and to filgrastim [G-CSF]. Erythropoiesis-stimulating agents (ESAs) will not be allowed during the initial 3 cycles and then will only be allowed in patients with hemoglobin levels of less than 9 g/dL. Rigosertib dosing adjustment policies are described in Protocol.
Last updated: 03/04/2013