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

Mohamad Bassam Sonbol; Daniel H. Ahn; David Goldstein; Takuji Okusaka; Josep Tabernero; Teresa Macarulla; Michele Reni; Chung Pin Li; Bert O'Neil; Eric Van Cutsem; Tanios Bekaii-Saab

doi:10.2217/fon-2018-0903

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

Mohamad Bassam Sonbol, Daniel H. Ahn, David Goldstein, Takuji Okusaka, Josep Tabernero, Teresa Macarulla, Michele Reni, Chung Pin Li, Bert O'Neil, Eric Van Cutsem, Tanios Bekaii-Saab

IRCCS Ospedale San Raffaele

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Pages (from-to)	1295-1302
Number of pages	8
Journal	Future Oncology
Volume	15
Issue number	12
DOIs	https://doi.org/10.2217/fon-2018-0903
Publication status	Published - Apr 2019

Keywords

BBI-608
cancer stem cells
CanStem111P
napabucasin
pancreatic adenocarcinoma

ASJC Scopus subject areas

Oncology
Cancer Research

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CanStem111P trial : A Phase III study of napabucasin plus nab-paclitaxel with gemcitabine. / Sonbol, Mohamad Bassam; Ahn, Daniel H.; Goldstein, David; Okusaka, Takuji; Tabernero, Josep; Macarulla, Teresa; Reni, Michele; Li, Chung Pin; O'Neil, Bert; Van Cutsem, Eric; Bekaii-Saab, Tanios.

In: Future Oncology, Vol. 15, No. 12, 04.2019, p. 1295-1302.

Research output: Contribution to journal › Article › peer-review

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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.",

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