Perioperative Fostamatinib With Gemcitabine and Nab-paclitaxel in Resectable Pancreatic Cancer
Trial Parameters
Brief Summary
This is a Phase 1b trial evaluating the combination of Fostamatinib, a Syk kinase inhibitor currently FDA-approved for chronic idiopathic thrombocytopenia purpura (ITP), with the standard of care chemotherapy agents gemcitabine and nab-paclitaxel, for the perioperative treatment of resectable non metastatic pancreatic ductal adenocarcinoma (PDAC).
Eligibility Criteria
Inclusion Criteria: 1. Patient has the ability to understand and willingness to sign a written informed consent. 2. Patient is ≥ 18 years of age. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1. 4. Patient must have surgical consult to verify patient is a surgical candidate within 28 days prior to enrollment. 5. Patient must have resectable primary PDAC based on contrast-enhanced CT or MRI of the chest, abdomen, and pelvis performed no more than 4 weeks before enrollment/baseline. Note that if CT or MRI was performed more than 4 weeks before this visit, imaging needs to be repeated to evaluate eligibility in the study. Resectable primary tumor is defined as: 1. No involvement of the celiac artery, common hepatic artery, and superior mesenteric artery (and, if present, replaced right hepatic artery). 2. No involvement, or \< 180° interface between tumor and vessel wall, of the portal vein and/or superior mesenteric vein. 3. Patent portal vein/splenic vein confluence.