TY - JOUR
T1 - NUC-1031/cisplatin vs gemcitabine/cisplatin in untreated locally advanced/metastatic biliary tract cancer (NuTide:121)
AU - Mcnamara, Mairead
AU - Goyal, Lipika
AU - Doherty, Mark
AU - Springfeld, Christoph
AU - Cosgrove, David
AU - Sjoquist, Katrin Marie
AU - Park, Joon Oh
AU - Verdaguer, Helena
AU - Braconi, Chiara
AU - Ross, Paul J
AU - Gramont, Aimery De
AU - Zalcberg, John Raymond
AU - Palmer, Daniel H
AU - Valle, Juan
AU - Knox, Jennifer J
PY - 2020/4/9
Y1 - 2020/4/9
N2 - Gemcitabine/cisplatin (GemCis) is standard of care for first-line treatment of patients with advanced biliary tract cancer (aBTC); new treatments are needed. NUC-1031 is designed to overcome key cancer resistance mechanisms associated with gemcitabine. The tolerability/efficacy signal of NUC-1031/cisplatin in the phase Ib ABC-08 study suggested this combination may represent a more efficacious therapy than GemCis for patients with aBTC, leading to initiation of the global NuTide:121 study which will include 828 patients ≥18 years with untreated histologically/cytologically-confirmed aBTC (including cholangiocarcinoma, gallbladder, or ampullary cancer); randomised (1:1) to NUC‑1031 (725mg/m2)/cisplatin (25mg/m2) or gemcitabine (1000mg/m2)/cisplatin (25mg/m2), on days 1/8, Q21-days. Primary objectives are OS and ORR. Secondary objectives: PFS, safety, pharmacokinetics, patient‑reported quality of life, and correlative studies.
AB - Gemcitabine/cisplatin (GemCis) is standard of care for first-line treatment of patients with advanced biliary tract cancer (aBTC); new treatments are needed. NUC-1031 is designed to overcome key cancer resistance mechanisms associated with gemcitabine. The tolerability/efficacy signal of NUC-1031/cisplatin in the phase Ib ABC-08 study suggested this combination may represent a more efficacious therapy than GemCis for patients with aBTC, leading to initiation of the global NuTide:121 study which will include 828 patients ≥18 years with untreated histologically/cytologically-confirmed aBTC (including cholangiocarcinoma, gallbladder, or ampullary cancer); randomised (1:1) to NUC‑1031 (725mg/m2)/cisplatin (25mg/m2) or gemcitabine (1000mg/m2)/cisplatin (25mg/m2), on days 1/8, Q21-days. Primary objectives are OS and ORR. Secondary objectives: PFS, safety, pharmacokinetics, patient‑reported quality of life, and correlative studies.
KW - Advanced biliary tract cancer; Pancreatic cancer; Biliary obstruction; Biliary stent; Stent-related event
KW - first-line treatment
KW - cisplatin
KW - gemcitabine
KW - NUC-1031
KW - overall survival
KW - objective response rate
M3 - Article
SN - 1479-6694
JO - Future oncology (London, England)
JF - Future oncology (London, England)
ER -
