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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 and day 23 of cycle 1 (each cycle is 28 days)

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

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