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Tyrosine Kinase Inhibitor
MRX-2843 + Osimertinib for Lung Cancer
Phase 1
Recruiting
Led By Taofeek K Owonikoko, MD, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ability to safely swallow oral medication
Serum creatinine =< 1.5 x the ULN or creatinine clearance (CrCl) >= 50 mL/min. For creatinine clearance estimation, the Cockcroft and Gault equation should be used
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment to time of progression or death, whichever occurs first, assessed at 1 year
Awards & highlights
Study Summary
This trial is testing a combination of drugs to see if they are effective in treating patients with lung cancer that has spread to other parts of the body. The drugs may work by blocking enzymes needed for cell growth.
Who is the study for?
This trial is for adults with advanced non-small cell lung cancer that has an EGFR mutation. Participants must be able to swallow pills, have certain blood counts and liver function, and not be pregnant or breastfeeding. They should agree to use contraception if there's a risk of pregnancy. People can't join if they have heart problems, untreated brain metastases, certain infections like HIV, or are on drugs affecting liver enzymes.Check my eligibility
What is being tested?
The trial is testing the combination of MRX-2843 and Osimertinib to find the safest dose and study side effects in patients whose lung cancer has spread. These drugs may block enzymes needed for tumor growth. The trial includes different groups based on prior treatments received.See study design
What are the potential side effects?
Potential side effects include issues with heart rhythm (QTc prolongation), inflammation of lungs (pneumonitis), eye problems (keratitis), allergic reactions similar to past allergies from related compounds, increased infection risk due to immune suppression, and possible interactions with other medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can safely take pills by mouth.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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My lung cancer has a specific EGFR mutation.
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I can take care of myself and am up and about more than half of the day.
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My liver enzymes are within the required limits.
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I am not pregnant and have negative pregnancy tests before treatment.
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I have NSCLC with worsening condition, previously treated or not with EGFR-TKI.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of treatment to time of progression or death, whichever occurs first, assessed at 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment to time of progression or death, whichever occurs first, assessed at 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD)
Recommended phase 2 dose (RP2D) of the tested combination (dose escalation)
Secondary outcome measures
1-year progression free survival rate (dose expansion)
Overall response rate (ORR) (dose expansion)
Predictive Protein Biomarkers
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (osimertinib, MRX-2843)Experimental Treatment2 Interventions
Patients receive osimertinib PO QD and MRX-2843 PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
2017
Completed Phase 4
~1010
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,642 Previous Clinical Trials
2,563,937 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,704 Previous Clinical Trials
40,931,373 Total Patients Enrolled
Taofeek K Owonikoko, MD, PhDPrincipal InvestigatorEmory University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have enough platelets in your blood.I agree to use birth control during and up to 4 months after the study.I agree to use two forms of birth control during and for 90 days after the study if I can have children and am sexually active with a man.I can safely take pills by mouth.You have enough white blood cells called neutrophils in your body.My lung cancer has a specific EGFR mutation.I have not taken osimertinib or any EGFR TKI for my condition, or if I have, it was over a year ago without recurrence.My bilirubin levels are within the normal range, even with liver issues or Gilbert's disease.I am a man who can father children and will use birth control during and for 3 months after the study.I can take care of myself and am up and about more than half of the day.My kidney function, measured by creatinine levels or clearance, is within the required range.I am not taking any drugs that affect liver enzymes.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I do not have symptoms from untreated brain metastases.My hemoglobin level is at least 8.5 g/dL and I haven't had a blood transfusion in the last 2 weeks.My cancer progressed after treatment with specific EGFR inhibitors and I am not positive for EGFR-T790M mutation.I am eligible for the backfill cohort because I don't fit into other groups but meet the general requirements.I am not pregnant or breastfeeding.My liver enzymes are within the required limits.I have a tumor that can be measured and is big enough according to specific guidelines.My heart's electrical activity (QTc interval) is normal and I have no family history of long QT syndrome.I have been diagnosed with interstitial lung disease or pneumonitis.I have a heart condition with reduced heart pump function.I have or might have retinitis pigmentosa, or it runs in my family.I have had keratitis or symptoms like eye pain, redness, or blurred vision.I am allergic to medications similar to MRX-2843 or osimertinib.I am not pregnant and have negative pregnancy tests before treatment.You are currently taking any experimental drugs.I do not have HIV or I am not on HIV medication.I have NSCLC with worsening condition, previously treated or not with EGFR-TKI.I have type 1 diabetes or am at high risk due to family history and my A1C is over 6.5%.I haven't had chemotherapy or radiotherapy in the last 4 to 6 weeks.I have no lasting side effects from previous cancer treatments above mild.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (osimertinib, 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies for patients to join this experiment?
"As indicated on the clinicaltrials.gov database, this trial is actively enrolling participants and was first introduced to the public on February 24th 2021 with its most recent update occuring on March 8th 2022."
Answered by AI
What evidence is there to support the efficacy of Flt3/MerTK Inhibitor MRX-2843?
"Currently, 101 investigations into Flt3/MerTK Inhibitor MRX-2843 are taking place with 17 trials in the final stage. Out of Uniondale, New york several studies on this subject matter have been initiated and a grand total of 4702 locations are running clinical trials for Flt3/MerTK Inhibitor MRX-2843."
Answered by AI
Is this a pioneering research project?
"Since 2013, research into Flt3/MerTK Inhibitor MRX-2843 has been ongoing. It was initially sponsored by AstraZeneca in a study involving 603 patients. Following the first trial, it received its Phase 1 & 2 drug approval and is now currently being studied across 1059 cities within 51 nations with 101 active trials."
Answered by AI
How many volunteers have participated in this experiment?
"Affirmative. The clinical trial is currently recruiting, as evidenced by the data hosted on clinicaltrials.gov from its inception date of February 24th 2021 and latest update on March 8th 2022. 69 volunteers are being sought across a single site for recruitment."
Answered by AI
Could you please expound on the risks of Flt3/MerTK Inhibitor MRX-2843?
"Assessing the safety of Flt3/MerTK Inhibitor MRX-2843 on a scale from 1 to 3, our team at Power have assigned it a score of 1 as this is still in its early Phase 1 trial and there is limited evidence regarding efficacy and safety."
Answered by AI
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