6 results
Based on results from a comparative review (Paoletti 2013), we hypothesize that if the toxicity profile and the PK parameters observed in children treated at the adult RP2D are similar to those in adults; escalating to the MTD is not necessarily…
1. Primary Objectives• To evaluate the safety and tolerability of VX 440 monotherapy and VX 440 in dual and triple combination with VX-661 and IVA• To evaluate the efficacy of VX 440 monotherapy and VX 440 in dual and triple combination with VX 661…
Primary Objective: To evaluate potential changes in body composition and REE after NMES therapy at home for 12 weeks.We hypothesize that NMES therapy would result in hypertrophy of gluteal and hamstring muscles, and an increase in LL-LBM, total LBM…
The primary objective of this study is to:• Determine the safety and tolerability of AG-120 and AG-221 when administered with induction and consolidation therapy in patients with newly diagnosed acute myeloid leukemia (AML) with an isocitrate…
Phase 1b Dose-finding Stage Primary Objectives· To assess the safety and tolerability of the combination treatments of oral AG-120 when administered with subcutaneous (SC) azacitidine and oral AG-221 when administered with SC azacitidine in subjects…
To assess efficacy and safety of ivosidenib/enasidenib vs. placebo in combination with induction therapy and consolidation therapy followed by maintenance therapy in patients with newly diagnosed acute myeloid leukemia (AML) or myelodysplastic…