McNamara, Mairead Geraldine, Goyal, Lipika, Doherty, Mark, Springfeld, Christoph, Cosgrove, David, Sjoquist, Katrin Marie, Park, Joon Oh, Verdaguer, Helena, Braconi, Chiara, Ross, Paul J et al (show 5 more authors)
(2020)
NUC-1031/cisplatin versus gemcitabine/cisplatin in untreated locally advanced/metastatic biliary tract cancer (NuTide:121).
FUTURE ONCOLOGY, 16 (16).
pp. 1069-1081.
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<sup>2</sup>)/cisplatin (25 mg/m<sup>2</sup>) or gemcitabine (1000 mg/m<sup>2</sup>)/cisplatin (25 mg/m<sup>2</sup>), 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. <b>(Investigational new drug (IND) number</b>: 139058, <b>European Clinical Trials database</b>: EudraCT Number 2019-001025-28, <b>ClinicalTrials.gov identifier</b>: NCT04163900).
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | advanced biliary tract cancer, cisplatin, first-line treatment, gemcitabine, NUC-1031, objective response rate, overall survival |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Systems, Molecular and Integrative Biology |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 13 Jul 2021 14:56 |
| Last Modified: | 18 Jan 2023 21:36 |
| DOI: | 10.2217/fon-2020-0247 |
| Open Access URL: | http://eprints.gla.ac.uk/215577/ |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3129899 |
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