A Phase 2 Study Assessing Utility of ctDNA in Early Switch of First-line mFOLFIRINOX in Metastatic Pancreatic Ductal Adenocarcinoma
The purpose of this study is to understand whether a blood-based test called circulating tumor DNA (ctDNA) can detect whether participants are having a desired tumor shrinkage or an undesired lack of tumor shrinkage, and to study whether these levels of ctDNA can be used to make treatment decisions faster than the current standard approach, which is to wait 8 weeks after starting chemotherapy to obtain participant first imaging scans since starting chemotherapy.
• 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.
• Treatment-naïve patients diagnosed with metastatic pancreatic adenocarcinoma.
• Must have a detectable circulating tumor deoxyribonucleic acid (DNA) at cycle 1 day 1.
• Patients must have a detectable circulating tumor deoxyribonucleic acid (ctDNA) quantity on Northstar Response assay at baseline.
• 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.
• Adult male and female participants (≥ 18 years of age).
• Male or non-pregnant and non-lactating female. Men and women with intact reproductive potential must agree to use contraception.
• 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.
• 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.
⁃ Eastern Cooperative Oncology Group (ECOG) performance status from 0 to ≤ 1.
⁃ Must be a modified Folfirinox chemotherapy candidate.
⁃ For participants not qualified or able to give legal consent, consent must be obtained from their legally authorized representative (LAR).