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


Journal

Future oncology (London, England)
ISSN: 1744-8301
Titre abrégé: Future Oncol
Pays: England
ID NLM: 101256629

Informations de publication

Date de publication:
Jun 2020
Historique:
pubmed: 7 5 2020
medline: 18 3 2021
entrez: 7 5 2020
Statut: ppublish

Résumé

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

Identifiants

pubmed: 32374623
doi: 10.2217/fon-2020-0247
doi:

Substances chimiques

NUC-1031 0
Deoxycytidine 0W860991D6
Cytidine Monophosphate F469818O25
Cisplatin Q20Q21Q62J
Gemcitabine 0

Banques de données

ClinicalTrials.gov
['NCT04163900']

Types de publication

Clinical Trial Protocol Clinical Trial, Phase III Journal Article Multicenter Study Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

1069-1081

Auteurs

Mairéad Geraldine McNamara (MG)

Division of Cancer Sciences, The University of Manchester & The Christie NHS Foundation Trust, Manchester, M20 4BX, UK.

Lipika Goyal (L)

Department of Medical Oncology, Massachusetts General Hospital, Boston, MA 02114, USA.

Mark Doherty (M)

Department of Medical Oncology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, M4Y 1H1, Canada.

Christoph Springfeld (C)

Heidelberg University Hospital, Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.

David Cosgrove (D)

Department of Medical Oncology, Sidney Kimmel Comp Cancer Center, The Johns Hopkins Hospital, Baltimore, MD 21287, USA.

Katrin Marie Sjoquist (KM)

NHMRC Clinical Trials Centre, The University of Sydney, Sydney, Australia.

Joon Oh Park (JO)

Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of (South) Korea.

Helena Verdaguer (H)

Department of Medical Oncology, Vall d'Hebron Institute of Oncology, Barcelona, Spain.

Chiara Braconi (C)

The University of Glasgow & the Beatson West of Scotland Cancer Centre, Glasgow, UK.

Paul J Ross (PJ)

Department of Medical Oncology, Guy's Hospital, London, UK.

Aimery De Gramont (A)

Department of Medical Oncology, Franco-British Institute, Levallois-Perret, France.

John Raymond Zalcberg (JR)

Department of Medical Oncology, Alfred Health & School of Public Health, Monash University, Melbourne, Australia.

Daniel H Palmer (DH)

Department of Medical Oncology, University of Liverpool, Liverpool, UK.

Juan W Valle (JW)

Division of Cancer Sciences, The University of Manchester & The Christie NHS Foundation Trust, Manchester, M20 4BX, UK.

Jennifer J Knox (JJ)

Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.

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Classifications MeSH