Pharmacokinetic and Safety Study of MRX-2843 in Adults With Relapsed/Refractory Advanced and/or M… (NCT03510104) | Clinical Trial Compass
CompletedPhase 1
Pharmacokinetic and Safety Study of MRX-2843 in Adults With Relapsed/Refractory Advanced and/or Metastatic Solid Tumors
United States42 participantsStarted 2018-05-22
Plain-language summary
This first-in-human open-label, dose escalation study is designed to evaluate the safety, tolerability, and PK of MRX-2843 in subjects with relapsed/refractory advanced and/or metastatic solid tumors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. Bilirubin ≤1.5x the upper limit of normal (ULN). For subjects with documented Gilbert's disease, bilirubin ≤3.0 mg/dL. For subjects with documented liver metastases, bilirubin ≤ 2.5x ULN.
. Serum creatinine ≤1.5x the ULN or creatinine clearance (CrCl) ≥50 mL/min.
. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3x the ULN (≤5x the ULN for subjects with liver metastases)
Exclusion criteria
. Subject has 1 first-degree relative (FDR; defined as parents, offspring or siblings) with T1D AND A1C value \> 6.5% or
. Subject has 2+FDR with T1D
. Radionuclide treatment within 6 weeks of the first dose of study drug in this study
. Local palliative radiation therapy (XRT) (small port) ≤2 weeks before first dose of study drug
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of subjects with Dose Limiting Toxicities (DLTs)
Timeframe: Baseline to the end of Cycle 1 (up to 28 days)
2
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
Timeframe: Baseline up to 14 days after last dose of study treatment (up to approximately 12 months)