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.
MeSH terms
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Administration, Oral
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Adult
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Albumins / administration & dosage*
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Albumins / adverse effects
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Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
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Antineoplastic Combined Chemotherapy Protocols / adverse effects
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Benzofurans / administration & dosage*
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Benzofurans / adverse effects
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Carcinoma, Pancreatic Ductal / drug therapy*
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Carcinoma, Pancreatic Ductal / mortality
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Clinical Trials, Phase III as Topic
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Deoxycytidine / administration & dosage
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Deoxycytidine / adverse effects
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Deoxycytidine / analogs & derivatives*
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Drug Administration Schedule
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Gemcitabine
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Humans
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Multicenter Studies as Topic
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Naphthoquinones / administration & dosage*
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Naphthoquinones / adverse effects
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Paclitaxel / administration & dosage*
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Paclitaxel / adverse effects
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Pancreatic Neoplasms / drug therapy*
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Pancreatic Neoplasms / mortality
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Progression-Free Survival
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Randomized Controlled Trials as Topic
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Young Adult
Substances
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130-nm albumin-bound paclitaxel
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Albumins
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Benzofurans
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Naphthoquinones
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napabucasin
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Deoxycytidine
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Paclitaxel
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Gemcitabine