- Histologically or cytologically diagnosis of metastatic ductal adenocarcinoma of the
pancreas.
- No prior radiotherapy, surgery chemotherapy or investigational therapy for metastatic
disease. Prior adjuvant therapy with 5-FU or gemcitabine (± gemcitabine post
radiation) administered as radiosensitizer allowed, provided at least 6 months have
elapsed between the last dose and study registration
- Tumor tissue available (Archival 6 months old or de novo biopsy)
- Measurable disease as per RECIST 1.1
- Performance Status (ECOG) 0 or 1
- Symptomatic brain metastases requiring steroids
- Prior therapy with gamma secretase inhibitors or other Notch pathway inhibitor
- Major surgery within 4 weeks of registration in the current study
- Known hypersensitivity to gemcitabine or nab-paclitaxel or any of the excipients
- Current or anticipated need for food or drugs that are strong/moderate CYP3A4
inhibitors or inducers
- Diagnosis of any second malignancy within 3 years prior to registration