Utility of ctDNA in Early Switch of First-line mFOLFIRINOX in Metastatic Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

• 1. Histologically confirmed, metastatic pancreatic adenocarcinoma. Patients with adenosquamous carcinoma and mixed adenocarcinoma/neuroendocrine carcinoma (MANEC) of the pancreas are eligible, but pure neuroendocrine neoplasms are excluded.
• 2. Treatment-naïve patients diagnosed with metastatic pancreatic adenocarcinoma.
• 3. Must have a detectable circulating tumor deoxyribonucleic acid (DNA) at cycle 1 day 1.
• 4. Patients must have a detectable circulating tumor deoxyribonucleic acid (ctDNA) quantity on Northstar Response assay at baseline.
• 5. At least one tumor measurable by Computed Tomography (CT) scan or Positron Emission Tomography-Computed Tomography (PET/CT) scan. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>20 mm with conventional techniques or \>10 mm with spiral CT scan.
• 6. Adult male and female participants (≥ 18 years of age).
• 7. Male or non-pregnant and non-lactating female. Men and women with intact reproductive potential must agree to use contraception.
• 8. Adequate biological parameters as demonstrated by the following blood counts at Screening (obtained ≤ 21 days prior to enrollment) and at Baseline-Day 0:
• * Absolute neutrophil count (ANC) ≥ 1.0 × 109 cells/L.
• * Platelet count ≥ 100,000 cells/mm3 (100 × 109 cells/L). Supportive platelet transfusions are acceptable.
• * Hemoglobin (Hgb) ≥ 9 g/dL. Supportive packed red blood cell transfusions are acceptable.
• 9. Adequate blood chemistry levels at Screening (obtained ≤ 21 days prior to enrollment) and at Baseline-Day 0:
• * Aspartate aminotransferase (AST) - serum glutamic-oxaloacetic transaminase (SGOT); alanine transaminase (ALT) - serum glutamic-pyruvic transaminase (SGPT) ≤ 2.5 × upper limit of normal (ULN) range, unless liver metastases are present, then ≤ 5 × ULN is allowed.
• * Total bilirubin ≤ 1.5 × Upper Limit of Normal.
• * Estimated creatinine clearance of \> 60 mL/min (per Cockcroft-Gault formula).
• * Albumin ≥ 3.0 g/dL.
• 10. Eastern Cooperative Oncology Group (ECOG) performance status from 0 to ≤ 1.
• 11. Must be a modified Folfirinox chemotherapy candidate.
• 12. For participants not qualified or able to give legal consent, consent must be obtained from their legally authorized representative (LAR).
• 1. Patients with pure neuroendocrine neoplasms of the pancreas.
• 2. Brain metastases.
• 3. Uncontrolled ascites.
• 4. Increase of ECOG to \> 1 between screening and enrollment.
• 5. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
• 6. History of untreated or uncontrolled HIV and/or Hepatitis B or C infection.
• 7. Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, including any of the following:
• * History of myocardial infarction, angina pectoris, symptomatic pericarditis, or coronary artery bypass graft within six months prior to study entry
• * Documented cardiomyopathy
• 8. Grade 2 or greater sensory peripheral neuropathy.
• 9. History of chronic diarrhea.
• 10. Pregnant or nursing.
• 11. Concomitant serious medical or psychiatric illness that, in the opinion of the investigator, could compromise the patient's safety or integrity of the study data.
• 12. Concurrently enrolled in any other interventional clinical protocol or investigational trial involving administration of antineoplastic compounds for the treatment of metastatic pancreatic cancer.
• 13. Patient is unwilling or unable to comply with study procedures.
• 14. Patients with impaired decision-making capacity.
• 15. No other medical condition or reason that, in the opinion of the investigator, would preclude study participation.