NUC-1031/cisplatin versus gemcitabine/cisplatin in untreated locally advanced/metastatic biliary tract cancer (NuTide:121)

McNamara, M. G. et al. (2020) NUC-1031/cisplatin versus gemcitabine/cisplatin in untreated locally advanced/metastatic biliary tract cancer (NuTide:121). Future Oncology, 16(16), pp. 1069-1081. (doi: 10.2217/fon-2020-0247) (PMID:32374623)

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/m2)/cisplatin (25 mg/m2) or gemcitabine (1000 mg/m2)/cisplatin (25 mg/m2), 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. (Investigational new drug (IND) number: 139058, European Clinical Trials database: EudraCT Number 2019-001025-28, ClinicalTrials.gov identifier: NCT04163900).

• Item Type: Articles
• Keywords: Clinical Trial Protocol, advanced biliary tract cancer, cisplatin, first-line treatment, gemcitabine, NUC-1031, objective response rate, overall survival
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Braconi, Dr Chiara
• Authors: McNamara, M. G., Goyal, L., Doherty, M., Springfeld, C., Cosgrove, D., Sjoquist, K. M., Park, J. O., Verdaguer, H., Braconi, C., Ross, P., Gramont, A. D., Zalcberg, J. R., Palmer, D. H., Valle, J. W., and Knox, J. J.
• College/School: College of Medical Veterinary and Life Sciences > School of Cancer Sciences
• Journal Name: Future Oncology
• Publisher: Future Medicine Ltd
• ISSN: 1479-6694
• ISSN (Online): 1744-8301
• Published Online: 06 May 2020
• Copyright Holders: Copyright © 2020 Future Medicine Ltd
• First Published: First published in Future Oncology 16(16): 1069-1081
• Publisher Policy: Reproduced in accordance with the publisher copyright policy