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 range18 Years
SexALL
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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
✕. Treatment with therapeutic doses of metaiodobenzylguanidine (MIBG) ≤6 weeks before first dose of study drug
✕. Prior total body irradiation, total craniospinal XRT, or ≥50% radiation of pelvis within 6 months of receiving first dose of study drug
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)