Pharmacokinetic and Safety Study of MRX-2843 in Adolescents and Adults With Relapsed/Refractory AML, ALL, or MPAL
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age12+
SponsorMeryx, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient is a male or female at least 12 years of age.
Patient must weigh at least 40 Kg.
Patient has histologically or cytologically confirmed diagnosis of AML as defined by the World Health Organization (WHO) criteria (2017), ALL, or MPAL and is in second or later relapse or is refractory to at least one induction regimen.
The effects of MRX-2843 on developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to remain abstinent, or agree to practice double barrier forms of birth control in which 2 of the following precautions are used during the study and for 4 months after last dose of study drug(s): vasectomy, tubal ligation (or other transcervical sterilization procedures), vaginal diaphragm, intrauterine device, birth control pills, birth control implant, or condom or sponge with spermicide.
Disqualifiers
Patient has diagnosis of acute promyelocytic leukemia (or AML M3).
Patients with known active CNS leukemia.
Patient has any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study drug, or any other condition that may place the patient at risk.
Patient has a history of other malignancies that have required systemic treatment within the last 2 years or are deemed by the investigator to have a potential to interfere with the safety and efficacy assessment of MRX2843. Patients with treated nonmelanoma skin cancer, in situ carcinoma or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed.
Trial design
Design model
Sequential
Treatments tested in this trial
MRX-2843
DrugMRX-2843 capsules
Treatment groups
50 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Dose Escalation - Level 1Experimental treatment 1 intervention
Group B: Dose Escalation - Level 2Experimental treatment 1 intervention
Group C: Dose Escalation - Level 3Experimental treatment 1 intervention
Group D: Dose Escalation - Level 4Experimental treatment 1 intervention
Group E: Dose Escalation - Level 5Experimental treatment 1 intervention
Group F: Expansion Arm at RP2DExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of subjects with Dose Limiting Toxicities (DLTs)
Time frame
Baseline to the end of Cycle 1 (up to 28 days)2
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)Secondary outcomes
1
Determine Maximum Tolerated Dose (MTD) in mg of MRX-2843
Time frame
Baseline to end of Cycle 1 (up to 28 days)2
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)3
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)4
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov