A Phase I/II Study of Ivaltinostat Combined with Gemcitabine and Erlotinib in Patients with Untreated Locally Advanced or Metastatic Pancreatic Adenocarcinoma

Histone deacetylase inhibitors (HDACi) are currently used as anticancer drugs; however, no clinical trials proved efficacy in pancreatic adenocarcinoma (PDAC). Ivaltinostat, a novel intravenous HDACi, presented cell growth inhibition and improved chemo-sensitivity in PDAC. This phase I/II study demonstrated ivaltinostat with gemcitabine and erlotinib can be administered safely to improve survivals in patients with untreated advanced PDAC. In addition, we proposed potential blood markers to predict response to ivaltinostat treatment based on correlative studies. To determine potential markers to predict the chemotherapy response to ivaltinostat, 6 patient samples were analyzed at the time of pretreatment(C1D1), on day 8 (C1D8) after treatment, and at the end of the trial (EOT) using antibody microarray analysis.