Napabucasin Plus FOLFIRI in Patients With Previously Treated Metastatic Colorectal Cancer: Results From the Open-Label, Randomized Phase III CanStem303C Study

MA Shah; T Yoshino; NC Tebbutt; A Grothey; J Tabernero; RH Xu; A Cervantes; SC Oh; K Yamaguchi; M Fakih; A Falcone; C Wu; VK Chiu; J Tomasek; J Bendell; M Fontaine; M Hitron; B Xu; J Taieb; E Van Cutsem

Journal article

Napabucasin Plus FOLFIRI in Patients With Previously Treated Metastatic Colorectal Cancer: Results From the Open-Label, Randomized Phase III CanStem303C Study

MA Shah, T Yoshino, NC Tebbutt, A Grothey, J Tabernero, RH Xu, A Cervantes, SC Oh, K Yamaguchi, M Fakih, A Falcone, C Wu, VK Chiu, J Tomasek, J Bendell, M Fontaine, M Hitron, B Xu, J Taieb, E Van Cutsem

Clinical Colorectal Cancer | Published : 2023

DOI: 10.1016/j.clcc.2022.11.002

Abstract

Purpose: Napabucasin is an investigational, orally administered reactive oxygen species generator bioactivated by intracellular antioxidant NAD(P)H:quinone oxidoreductase 1 that has been evaluated in various solid tumors, including metastatic colorectal cancer (mCRC). Phosphorylated signal transducer and activator of transcription 3 (pSTAT3) is hypothesized to predict response in napabucasin-treated patients with mCRC. Patient and Methods: In the multi-center, open-label, phase III CanStem303C (NCT02753127) study, adults with histologically confirmed mCRC that progressed on first-line fluoropyrimidine plus oxaliplatin ± bevacizumab were randomized to twice-daily napabucasin plus FOLFIRI (nap..

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