@article{bea834bd0b554c28a84a9f66241c6a9d,
title = "CanStem111P trial: A Phase III study of napabucasin plus nab-paclitaxel with gemcitabine",
abstract = "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.",
keywords = "BBI-608, CanStem111P, cancer stem cells, napabucasin, pancreatic adenocarcinoma",
author = "Sonbol, {Mohamad Bassam} and Ahn, {Daniel H.} and David Goldstein and Takuji Okusaka and Josep Tabernero and Teresa Macarulla and Michele Reni and Li, {Chung Pin} and Bert O'Neil and {Van Cutsem}, Eric and Tanios Bekaii-Saab",
note = "Funding Information: D Ahn reports consulting for Eisai and Astellas. EV Cutsem reports consulting/advisory role for Bayer, Lilly, Roche, SERVIER, BMS, Celgene, Merck Sharp & Dohme, Merck KGaA, Novartis; research funding to institutions: Amgen, Bayer, Boehringer Ingelheim, Lilly, Novartis, Roche, Celgene, Ipsen, Merck, Merck KGaA, SERVIER and BMS. T Okusaka reports research grant from Sumitomo Dainippon Pharma. T Macarulla reports receiving honoraria for consultancy from Shire Pharmaceuticals, Roche, Tesaro, Baxter, Sanofi, Celgene, QED Therapeutics, Genzyme Europe, Baxalta. She had also received support for travel or accommodation from Merck, H3 Biomedicine, Bayer, Sanofi. R Michelle reports grants, personal fees and nonfinancial support from Celgene, grants and personal fees from Baxalta, grants and personal fees from Merck Serono, grants from Helsinn, personal fees from Lilly, personal fees from Pfizer, personal fees from AstraZeneca, personal fees from Novocure, personal fees from Halozyme, personal fees from Novartis, personal fees from Shire, during the conduct of the study. J Tabernero reports personal financial interest in the form of scientific consultancy role for Array Biopharma, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Chugai, Genentech, Inc., Genmab A/S, Halozyme, Imugene Limited, Inflection Biosciences Limited, Ipsen, Kura Oncology, Lilly, MSD, Menarini, Merck Serono, Merrimack, Merus, Molecular Partners, Novartis, Peptomyc, Pfizer, Pharmacyclics, ProteoDesign SL, Rafael Pharmaceuticals, F Hoffmann-La Roche Ltd, Sanofi, SeaGen, Seattle Genetics, Servier, Symphogen, Taiho, VCN Biosciences, Biocartis, Foundation Medicine, HalioDX SAS and Roche Diagnostics. D Goldstein reports Celgene research grant to his institution. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript Funding Information: CanStem111P is a randomized, open label, Phase III study (NCT02993731) assessing the efficacy of the addition of napabucasin to weekly nab-paclitaxel and gemcitabine for first-line treatment of patients with mPDAC. This study is sponsored by Boston Biomedical, Inc. Publisher Copyright: {\textcopyright} 2019 Future Medicine Ltd.",
year = "2019",
month = apr,
doi = "10.2217/fon-2018-0903",
language = "English (US)",
volume = "15",
pages = "1295--1302",
journal = "Future Oncology",
issn = "1479-6694",
publisher = "Future Medicine Ltd.",
number = "12",
}