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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)
Must not have
Patient has an active uncontrolled infection
Patient has a history of Type 1 Diabetes (T1D) or is considered at high risk for T1D
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and day 23 of cycle 1 (each cycle is 28 days)
Awards & highlights
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an ongoing infection that isn't under control.
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I have Type 1 Diabetes or am at high risk for it.
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I have active and serious graft-versus-host disease.
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I have been diagnosed with active hepatitis B or C.
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I had major surgery less than 4 weeks ago.
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I have active leukemia in my brain or spinal cord.
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I have been diagnosed with acute promyelocytic leukemia.
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I have or suspect I have retinitis pigmentosa, or it runs in my family.
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)
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any experimental drugs or kinase inhibitors in the last 28 days or longer.I have an ongoing infection that isn't under control.I haven't had systemic treatment for other cancers in the last 2 years, except for certain skin or cervical conditions.My kidney function, measured by creatinine clearance, is good.I have Type 1 Diabetes or am at high risk for it.I have had radionuclide treatment within the last 6 weeks.I can care for myself but may not be able to do active work.I have FLT3ITD+ and was treated with a FLT3 inhibitor before.I weigh at least 40 Kg.My leukemia diagnosis is confirmed and it has not responded to at least one treatment.My white blood cell count is below 25,000/mm3, or I am taking hydroxyurea to lower it for the study.I am willing and able to follow the study rules and work with the research team.My heart function is good despite past severe heart failure.I have active and serious graft-versus-host disease.I have been diagnosed with active hepatitis B or C.I don't have any health issues that could affect how a drug works in my body.I haven't had cancer treatment in the last 14 days, except possibly hydroxyurea.I am not pregnant or breastfeeding and have negative pregnancy tests.I can take pills by mouth.I still have side effects from previous treatments, except for hair loss.I am at least 12 years old.I had major surgery less than 4 weeks ago.I have active leukemia in my brain or spinal cord.I agree to use two forms of birth control or remain abstinent.I need blood thinners or antiplatelet drugs for my condition.I have taken calcineurin inhibitors within the last month.I have been diagnosed with acute promyelocytic leukemia.I have or suspect I have retinitis pigmentosa, or it runs in my family.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation - Level 4
- Group 2: Dose Escalation - Level 5
- Group 3: Expansion Arm at RP2D
- Group 4: Dose Escalation - Level 1
- Group 5: Dose Escalation - Level 3
- Group 6: Dose Escalation - Level 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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