This is a Phase I, open-label, non-randomized, dose escalation study in adolescents and adults with relapsed/refractory acute myeloid leukemia, acute lymphoblastic leukemia, or mixed phenotype acute leukemia. Patients will receive continuous oral MRX-2843 in 28 day cycles at predefined dose cohorts.
This is a Phase I, open-label, non-randomized, dose escalation study in up to 50 adolescent or adult patients with relapsed/refractory acute myeloid leukemia, acute lymphoblastic leukemia, or mixed phenotype acute leukemia. Patients will receive a single dose of MRX-2843 followed by continuous oral MRX-2843 in 28 day cycles at predefined dose cohorts. A dose expansion arm of approximately 12 patients (with 6 patients being FLT3 ITD+ and 6 patients being Mer+/FLT3 WT) will be accrued to further evaluate patients at the RP2D.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
MRX-2843 capsules
Emory University - WINSHIP Cancer Center
Atlanta, Georgia, United States
RECRUITINGEmory University, Children's Healthcare of Atlanta
Atlanta, Georgia, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGPercentage of subjects with Dose Limiting Toxicities (DLTs)
Time frame: Baseline to the end of Cycle 1 (up to 28 days)
Percentage of subjects with Adverse Events (AEs) and Serious Adverse Events (SAEs) graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5
Time frame: Baseline up to 14 days after last dose of study treatment (up to approximately 8 months)
Determine Maximum Tolerated Dose (MTD) in mg of MRX-2843
Time frame: Baseline to end of Cycle 1 (up to 28 days)
AUC0-t: area under the concentration-time curve from time 0 to the time of the last
Time frame: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)
AUC0-inf: area under the concentration-time curve from time 0 to infinity
Time frame: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)
AUC0-τ: area under the concentration-time curve from time 0 to tau, where tau is the dosing interval
Time frame: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)
Cmax: maximum observed plasma concentration
Time frame: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)
Tmax: time to reach maximum observed plasma concentration
Time frame: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)
λz: terminal phase elimination rate constant
Time frame: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)
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t1/2: apparent terminal elimination half-life
Time frame: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)
CL/F: apparent total body clearance
Time frame: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)
Vz/F: apparent volume of distribution of the terminal phase
Time frame: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)