Myelodysplastic Syndromes Clinical Trial
Official title:
Ph 1b Dose Escalation Study of OXi4503 as a Single Agent and in Combination With Cytarabine With Subsequent Phase 2 Cohorts for Subjects With Relapsed/Refractory Acute AML and MDS
Phase 1 will investigate maximum tolerated dose of OXi4503 as a single agent and in
combination with intermediate-dose cytarabine in subjects with relapsed/refractory AML or
MDS.
Phase 2 will investigate overall response rate of OXi4503 in combination with
intermediate-dose cytarabine in 1) subjects with MDS after failure of 1 prior hypomethylating
agent (Arm A) and 2) subjects with relapsed and refractory AML after treatment failure of up
to 1 prior chemotherapy regimen (Arm B).
Phase 1 dose escalation component will assess the safety, PK/PD, and preliminary efficacy of
OXi4503 as a single agent in subjects with relapsed/refractory AML and MDS, and the safety
and PK/PD of the combination of OXi4503 with intermediate-dose cytarabine in subjects with
AML/MDS.
Phase 2 will assess the preliminary efficacy of the OXi4503+cytarabine combination in 2
cohorts.
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