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

Inclusion 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).