Circulating Tumor DNA to Determine Early Switch From First-Line mFOLFIRINOX to Second-Line Gemcitabine and Nab-paclitaxel in Metastatic Pancreatic Ductal Adenocarcinoma

Inclusion Criteria

• 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 DNA at cycle 1 day 1
• Patients must have a detectable ctDNA quantity on Northstar RESPONSE assay at baseline
• At least one tumor measurable by CT scan or 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
• Absolute neutrophil count (ANC) ≥ 1.0 x 10^9 cells/L (at screening [obtained ≤ 21 days prior to enrollment] and at baseline [day 0])
• Platelet count ≥ 100,000 cells/mm^3. (at screening [obtained ≤ 21 days prior to enrollment] and at baseline [day 0]) Supportive platelet transfusions are acceptable
• Hemoglobin (Hgb) ≥ 9 g/dL. (at screening [obtained ≤ 21 days prior to enrollment] and at baseline [day 0]) Supportive packed red blood cell transfusions are acceptable
• Aspartate aminotransferase (AST)-serum glutamic-oxaloacetic transaminase (SGOT); alanine aminotransferase (ALT)-serum glutamic-pyruvic transaminase (SGPT) ≤ 2.5 x upper limit of normal (ULN) range, (at screening [obtained ≤ 21 days prior to enrollment] and at baseline [day 0]) unless liver metastases are present, then ≤ 5 x ULN is allowed
• Total bilirubin ≤ 1.5 x ULN (at screening [obtained ≤ 21 days prior to enrollment] and at baseline [day 0])
• Estimated creatinine clearance of > 60 mL/min (per Cockcroft-Gault formula) (at screening [obtained ≤ 21 days prior to enrollment] and at baseline [day 0])
• Albumin ≥ 3.0 g/dL (at screening [obtained ≤ 21 days prior to enrollment] and at baseline [day 0])
• Eastern Cooperative Oncology Group (ECOG) performance status from 0 to ≤ 1
• Must be a mFOLFIRINOX chemotherapy candidate

Exclusion Criteria

• Patients with pure neuroendocrine neoplasms of the pancreas
• Brain metastases
• Uncontrolled ascites
• Increase of ECOG to > 1 between screening and enrollment
• Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
• History of untreated or uncontrolled HIV and/or hepatitis B or C infection
• 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
• Grade 2 or greater sensory peripheral neuropathy
• History of chronic diarrhea
• Pregnant or nursing
• 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
• Concurrently enrolled in any other interventional clinical protocol or investigational trial involving administration of antineoplastic compounds for the treatment of metastatic pancreatic cancer
• Patient is unwilling or unable to comply with study procedures
• Patients with impaired decision-making capacity. No other medical condition or reason that, in the opinion of the investigator, would preclude study participation