NUC-1031/cisplatin versus gemcitabine/cisplatin in untreated locally advanced/metastatic biliary tract cancer (NuTide: 121)
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 i...
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| Hauptverfasser: | , , , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
6 May 2020
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| In: |
Future oncology
Year: 2020, Jahrgang: 16, Heft: 16, Pages: 1069-1081 |
| ISSN: | 1744-8301 |
| DOI: | 10.2217/fon-2020-0247 |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.2217/fon-2020-0247 Verlag, lizenzpflichtig, Volltext: https://www.futuremedicine.com/doi/10.2217/fon-2020-0247 
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| Verfasserangaben: | Mairéad Geraldine McNamara, Lipika Goyal, Mark Doherty, Christoph Springfeld, David Cosgrove, Katrin Marie Sjoquist, Joon Oh Park, Helena Verdaguer, Chiara Braconi, Paul J. Ross, Aimery De Gramont, John Raymond Zalcberg, Daniel H. Palmer, Juan W. Valle, Jennifer J. Knox |
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| 520 | |a 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). | ||
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