A phase II study of Guadecitabine (G) with Irinotecan (IRI) vs regorafenib or TAS-102 in metastatic colorectal cancer (mCRC) patients (pts)

Background: Treatment of IRI-resistant CRC lines with a DNA methyltransferase inhibitor (DNMTi) reverses IRI resistance. A phase I trial demonstrated safety of the combination G + IRI in treatment of mCRC pts. We completed a large randomized phase II trial of G+IRI compared to regorafenib or TAS-102 in pts with advanced mCRC refractory to irinotecan.