Phase I dose escalation study of pomalidomide in combination with gemcitabine in patients (pts) with untreated metastatic carcinoma of the pancreas

e15539 Background: Pomalidomide is an IMiD immunomodulatory compound that is synergistic with gemcitabine in preclinical models. Pomalidomide has immuno-stimulatory properties and effects on the tumor microenvironment including inhibition of inflammatory mediators, stromal cell support, endothelial cell function, and angiogenesis. The primary objective is to determine the maximally tolerated dose (MTD) and evaluate the safety profile of pomalidomide in combination with gemcitabine. Methods: Eligibility included pts with untreated metastatic pancreatic cancer, adequate organ function, ECOG 0–1, and willingness to take prophylactic anticoagulation with aspirin, low-dose coumadin, or low molecular weight heparin. Gemcitabine 1,000 mg/m2 was given as a 30 min IV infusion on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was given orally, daily for 21 days of a 28 day cycle. 3–6 pts were enrolled to increasing dose cohorts of pomalidomide (2, 3, 5, 7, and 10 mg/day) until dose-limiting toxicity (DLT) was se...