CanStem111P trial: a Phase III study of napabucasin plus nab-paclitaxel with gemcitabine.


Journal

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

Informations de publication

Date de publication:
Apr 2019
Historique:
pubmed: 16 2 2019
medline: 20 8 2019
entrez: 16 2 2019
Statut: ppublish

Résumé

Napabucasin (also known as BBI-608 or BBI608) is an investigational, oral agent hypothesized to inhibit multiple oncogenic pathways. In this article, we describe the design and rationale for the CanStem111P clinical trial, a multicenter, randomized, open-label, Phase III study designed to determine the efficacy and safety of combining napabucasin with nab-paclitaxel and gemcitabine for first-line treatment of patients with metastatic pancreatic adenocarcinoma (NCT02993731). Patients were randomized in a 1:1 fashion to receive weekly gemcitabine and nab-paclitaxel with or without napabucasin. The results of this study will help define the role of this novel agent in the management of advanced pancreatic cancer.

Identifiants

pubmed: 30768369
doi: 10.2217/fon-2018-0903
doi:

Substances chimiques

130-nm albumin-bound paclitaxel 0
Albumins 0
Benzofurans 0
Naphthoquinones 0
napabucasin 0
Deoxycytidine 0W860991D6
Paclitaxel P88XT4IS4D
Gemcitabine 0

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Pagination

1295-1302

Auteurs

Mohamad Bassam Sonbol (MB)

Mayo Clinic Cancer Center, Mayo Clinic, Phoenix, AZ 85054, USA.

Daniel H Ahn (DH)

Mayo Clinic Cancer Center, Mayo Clinic, Phoenix, AZ 85054, USA.

David Goldstein (D)

Department of Medical Oncology, Prince of Wales Hospital, Sydney, NSW, Australia.

Takuji Okusaka (T)

Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.

Josep Tabernero (J)

Vall d'Hebron University Hospital & Institute of Oncology (VHIO), CIBERONC, Universitat Autònoma de Barcelona, Barcelona, Spain.

Teresa Macarulla (T)

Vall d'Hebron University Hospital & Institute of Oncology (VHIO), Barcelona, Spain.

Michele Reni (M)

Department of Medical Oncology, IRCCS San Raffaele Scientific Institute, Milan, Italy.

Chung-Pin Li (CP)

Division of Gastroenterology & Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.
National Yang-Ming University School of Medicine, Taipei, Taiwan.

Bert O'Neil (B)

Department of Medicine, IU Health University Hospital, Indianapolis, IN, 46202, USA.

Eric Van Cutsem (E)

University Hospital Gasthuisberg, Leuven & KU Leuven, Leuven, Belgium.

Tanios Bekaii-Saab (T)

Mayo Clinic Cancer Center, Mayo Clinic, Phoenix, AZ 85054, USA.

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Classifications MeSH