Study Of PF-03084014 In Combination With Gemcitabine And Nab-Paclitaxel In Patients With Metastatic Pancreatic Adenocarcinoma Not Previously Treated With Anticancer Therapies

PHASE 1/2 STUDY OF PF-03084014 IN COMBINATION WITH GEMCITABINE AND NAB-PACLITAXEL IN PATIENTS WITH PREVIOUSLY UNTREATED METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA

This study consists of a Phase 1b portion aimed to determine the maximum tolerated dose and the safety profile of PF-03084014 in combination with gemcitabine and nab-paclitaxel followed by a Phase 2 portion to evaluate the efficacy of the triple combination in terms of overall survival in patients with metastatic pancreatic ductal adenocarcinoma not previously treated with anticancer therapies.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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