Phase I study of combination of pasireotide (SOM 230) plus gemcitabine in metastatic pancreatic cancer (MPC).

e15075 Background: For the past decade, gemcitabine (GEM) has been considered the standard chemotherapeutic agent in the treatment of MPC. SOM-230 is a multi-targeted somatostatin (SST) receptor (sst1,2,3 and 5) analog with five times the affinity of other SST receptor analogs and a potent inhibitor of insulin growth factor -1(IGF-1). SST receptors and IGF receptors are highly expressed in pancreatic cancer therefore potentially making it a valuable target. Methods: Patients with previously untreated MPC and ECOG PS 0-1 were eligible for the trial. A 3+3 dose escalation design was used. Patients with MPC received GEM 1000 mg/m2 (30-min, once-weekly IV infusion for 3 out of 4 weeks) and SOM 230 according to dose escalation. 2 dose levels (DL) were planned. (40mg and 60 mg IM once a month). Following MTD determination the plan was to expand the cohort to 10 more patients to assess efficacy. In the expanded cohort plasma levels of IGF-I, IGFBP (insulin growth factor binding protein)-1, and IGFBP-3 were measu...