NUC-1031/cisplatin versus gemcitabine/cisplatin in untreated locally advanced/metastatic biliary tract cancer (NuTide:121).
Future Oncol
; 16(16): 1069-1081, 2020 Jun.
Article
en En
| MEDLINE
| ID: mdl-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 NuTide121 study which will include 828 patients ≥18 years with untreated histologically/cytologically-confirmed aBTC (including cholangiocarcinoma, gallbladder or ampullary cancer); randomized (11) 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).Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Conductos Biliares Intrahepáticos
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Neoplasias del Sistema Biliar
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Protocolos de Quimioterapia Combinada Antineoplásica
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Colangiocarcinoma
Tipo de estudio:
Clinical_trials
Aspecto:
Patient_preference
Límite:
Adolescent
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Adult
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Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Future Oncol
Año:
2020
Tipo del documento:
Article
País de afiliación:
Reino Unido