P-385 A phase 1/2 study of combination therapy of ivaltinostat, gemcitabine, and erlotinib in patients with unresectable, locally advanced and metastatic pancreatic adenocarcinoma

Abstract

individuals prognostic tests identified overall, -/+ HDAA, groups with median survivals of 15.5 -24 mos. HDAA did not significantly reduce survival. Severe AEs range from 0-< 5% in HDAA groups. Favorable S trends were attributable to Taxanes, % females and A.L.A.N. cell ratios. The latter are putative surrogate markers of immune function. Unexpectedly, contrary to clinical characteristics, and referring physician expectations, the majority of patients had up to 75% favorable prognostic tests. Conclusion:All comparisons, -/+ HDAA, found no decrease in palliative S. All S end points results: median, 25th percentile, 12 and 24 mos, encourage broad treatment, regardless of resistance and age. The A.L.A.N. score and its elements defined S subsets. HDAA is safe with the GFLIO drugs in moderate dosages. Further phase II/III clinical trials are recommended.

The State-of-the-Art of Phase II/III Clinical Trials for Targeted Pancreatic Cancer Therapies

“…A preclinical study by Lee et al showed growth inhibition and anti-neoplastic effects in gemcitabine-resistant pancreatic cancer cells, following treatment with CG200745 plus gemcitabine and erlotinib (an EGFR inhibitor) in vitro and in vivo [193]. One phase I/II study explored the clinical effects of this combination (CG200745 plus gemcitabine and erlotinib) in 34 patients with unresectable, locally advanced/metastatic pancreatic cancer (NCT02737228) [194]. Part I consisted of 10 patients and set out to outline the maximum tolerated dose of CG200745, with results determining this to be 250 mg/m 2 .…”