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A Phase 1, Open-Label, Dose-Escalation with Expansion Study of SX-682 in Subjects with Myelodysplastic Syndrome Who Had Disease Progression or are Intolerant to Prior Therapy
This study will determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and recommended Phase 2 dose (RP2D) of SX-682 in the treatment of patients with Myelodysplastic Syndromes (MDS).
The primary objective is to determine the safety profile of SX-682 in subjects with MDS, including the maximum dose that can be administered until adverse effects prevent further dose increases (i.e., the MTD or recommended phase 2 dose), and the dose-limiting toxicity (DLT). The secondary objectives are to: 1. Estimate the overall best response rates of SX-682 using standard international working group (IWG) 2006 response criteria. 2. Determine the duration of response. 3. Determine the rate and time to acute myeloid leukemia (AML) transformation. 4. Determine the median overall survival (OS). 5. Characterize single-dose and multi-dose pharmacokinetic (PK) profile of SX-682 and its metabolite M1 at Day 1 and 15 of Cycle 1, respectively. For the 100 mg dose, additionally determine the effect of food at Day -3.