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MRX-2843 for Leukemia

Phase 1
Recruiting
Led By Melinda Pauley, MD
Research Sponsored by Meryx, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must weigh at least 40 Kg
Creatinine clearance (CrCl) ≥ 60 mL/min. For creatinine clearance estimation, the Cockcroft and Gault equation should be used: Male: CrCl (mL/min) = (140 - age) × wt (kg) / (serum creatinine × 72) (For females: Multiply above result by 0.85)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and day 23 of cycle 1 (each cycle is 28 days)
Awards & highlights

Study Summary

This trial is testing a new drug for people with leukemia who haven't responded to other treatments. The drug will be given in increasing doses to see what effect it has.

Who is the study for?
This trial is for adolescents and adults at least 12 years old with relapsed/refractory acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or mixed phenotype acute leukemia (MPAL). Participants must weigh over 40 Kg, have specific blood test results within certain limits, be able to swallow pills, and not be pregnant. They should also agree to use double barrier contraception methods.Check my eligibility
What is being tested?
The study tests MRX-2843, an oral medication given in continuous cycles of 28 days to see its safety and how the body processes it. It's a Phase I trial where doses increase gradually among groups of patients until they find the highest dose that doesn't cause unacceptable side effects.See study design
What are the potential side effects?
Potential side effects are not specified here but generally may include typical reactions seen with cancer treatments such as nausea, fatigue, liver function changes, blood count variations which could lead to increased risk of infections or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh at least 40 Kg.
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My kidney function, measured by creatinine clearance, is good.
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I can care for myself but may not be able to do active work.
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My leukemia diagnosis is confirmed and it has not responded to at least one treatment.
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I am not pregnant or breastfeeding and have negative pregnancy tests.
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I agree to use two forms of birth control or remain abstinent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and day 23 of cycle 1 (each cycle is 28 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and day 23 of cycle 1 (each cycle is 28 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Percentage of subjects with Dose Limiting Toxicities (DLTs)
Secondary outcome measures
AUC0-inf: area under the concentration-time curve from time 0 to infinity
AUC0-t: area under the concentration-time curve from time 0 to the time of the last
AUC0-τ: area under the concentration-time curve from time 0 to tau, where tau is the dosing interval
+7 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Expansion Arm at RP2DExperimental Treatment1 Intervention
MRX-2843 capsules, QD - 28 day cycles
Group II: Dose Escalation - Level 5Experimental Treatment1 Intervention
MRX-2843 capsules, QD - 28 day cycles
Group III: Dose Escalation - Level 4Experimental Treatment1 Intervention
MRX-2843 capsules, QD - 28 day cycles
Group IV: Dose Escalation - Level 3Experimental Treatment1 Intervention
MRX-2843 capsules, QD - 28 day cycles
Group V: Dose Escalation - Level 2Experimental Treatment1 Intervention
MRX-2843 capsules, QD - 28 day cycles
Group VI: Dose Escalation - Level 1Experimental Treatment1 Intervention
MRX-2843 capsules, QD - 28 day cycles

Find a Location

Who is running the clinical trial?

Meryx, Inc.Lead Sponsor
1 Previous Clinical Trials
42 Total Patients Enrolled
Melinda Pauley, MDPrincipal InvestigatorEmory University, Children's Healthcare of Atlanta
William Blum, MDPrincipal InvestigatorEmory University
2 Previous Clinical Trials
16 Total Patients Enrolled

Media Library

MRX-2843 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04872478 — Phase 1
Acute Myeloid Leukemia Research Study Groups: Dose Escalation - Level 4, Dose Escalation - Level 5, Expansion Arm at RP2D, Dose Escalation - Level 1, Dose Escalation - Level 3, Dose Escalation - Level 2
Acute Myeloid Leukemia Clinical Trial 2023: MRX-2843 Highlights & Side Effects. Trial Name: NCT04872478 — Phase 1
MRX-2843 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04872478 — Phase 1
~2 spots leftby Jul 2024