AI Article Synopsis
- Gemcitabine/cisplatin is the usual treatment for advanced biliary tract cancer (aBTC), but scientists want to find better options.
- NUC-1031 is a new drug that might work better and help patients more than the standard treatment.
- A new study called NuTide:121 is testing NUC-1031 with cisplatin on 828 patients to see if it helps them live longer and feel better compared to the old treatment.
Article Abstract
Gemcitabine/cisplatin 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 that this combination may represent a more efficacious therapy than gemcitabine/cisplatin 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); randomized (1:1) to NUC-1031 (725 mg/m)/cisplatin (25 mg/m) or gemcitabine (1000 mg/m)/cisplatin (25 mg/m), on days 1/8, Q21-days. Primary objectives are overall survival and objective response rate. Secondary objectives: progression-free survival, safety, pharmacokinetics, patient-reported quality of life and correlative studies. : 139058, : EudraCT Number 2019-001025-28, : NCT04163900).
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| http://dx.doi.org/10.2217/fon-2020-0247 | DOI Listing |
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