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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
Determination of MTD of OXi4503
Determination of MTD of the combination of OXi4503 + cytarabine
Safety and efficacy of the combination of OXi4503 + cytarabine in subjects with AML
Safety and efficacy of the combination of OXi4503 + cytarabine in subjects with MDS
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
RECRUITINGUniversity of Florida
Gainesville, Florida, United States
RECRUITINGUniversity of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
RECRUITINGUniversity of Kansas Cancer Center and Medical Pavilion
Westwood, Kansas, United States
RECRUITINGPhase 1b:MTD of OXi4503 as a single agent and in combination with intermediate-dose cytarabine in subjects with relapsed/refractory AML or MDS
Time frame: 1 year
Phase 2: Overall response rate of OXi4503 in combination with intermediate-dose cytarabine in subjects with MDS after failure of 1 prior hypomethylating agent (Arm A), and subjects with relapsed and refractory AML after treatment failure of up
Time frame: 2 years
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