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MRX-2843 for Advanced Refractory Cancer
Phase 1
Waitlist Available
Led By Donald Harvey
Research Sponsored by Meryx, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Nonsterilized males who are sexually active with a female of childbearing potential must agree to use an acceptable method of effective contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 14 days after last dose of study treatment (up to approximately 12 months)
Awards & highlights
Study Summary
This trial is testing a new drug to see if it is safe and works well against cancer that has come back or does not respond to other treatments.
Who is the study for?
Adults with advanced solid tumors that have relapsed or spread, who've tried at least one treatment without success. They must be over 18, able to take oral meds, and not pregnant or breastfeeding. Participants need normal organ function tests and agree to use effective contraception during the trial.Check my eligibility
What is being tested?
The study is testing MRX-2843's safety and how it moves through the body (pharmacokinetics) in people with stubborn cancers that haven't responded well to other treatments. It's an early-stage trial where everyone gets MRX-2843.See study design
What are the potential side effects?
Specific side effects of MRX-2843 aren't listed but may include typical reactions seen with cancer drugs such as nausea, fatigue, blood count changes, liver issues, and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
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I am a man who can father children and will use birth control.
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I am not pregnant, not breastfeeding, and my pregnancy test was negative.
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My cancer is confirmed and can be measured or evaluated.
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I've had one treatment for my advanced illness and there are no approved treatments left.
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I agree to use two forms of birth control if I can have children and am sexually active.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 14 days after last dose of study treatment (up to approximately 12 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 14 days after last dose of study treatment (up to approximately 12 months)
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 quantifiable concentration (t)
AUC0-τ: area under the concentration-time curve from time 0 to tau, where tau is the dosing interval
+7 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: MRX-2843Experimental Treatment1 Intervention
MRX-2843: Dose Escalation Successive dose escalation cohorts to determine MTD
Find a Location
Who is running the clinical trial?
Meryx, Inc.Lead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
Donald HarveyPrincipal InvestigatorEmory University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had surgery less than a month ago or have ongoing wound issues.I can take care of myself but might not be able to do heavy physical work.I am a man who can father children and will use birth control.I am not pregnant, not breastfeeding, and my pregnancy test was negative.I can take pills by mouth.I have a condition that could affect how my body handles medication.I have or might have an autoimmune disease.I have Type 1 Diabetes or am at high risk for it.I still feel side effects from my previous cancer treatments.I need to take certain blood thinners.My cancer is confirmed and can be measured or evaluated.I've had one treatment for my advanced illness and there are no approved treatments left.I agree to use two forms of birth control if I can have children and am sexually active.My high blood pressure is not under control.I am willing and able to follow the study rules.I have or might have retinitis pigmentosa.I have a serious illness that is not under control.I had a serious heart problem in the last 6 months.I have been diagnosed with chronic active hepatitis B or C.I am 18 years old or older.I have received specific treatments recently.
Research Study Groups:
This trial has the following groups:- Group 1: MRX-2843
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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