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

Future Oncol. 2019 Apr;15(12):1295-1302. doi: 10.2217/fon-2018-0903. Epub 2019 Feb 15.

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.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Administration, Oral
  • Adult
  • Albumins / administration & dosage*
  • Albumins / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Benzofurans / administration & dosage*
  • Benzofurans / adverse effects
  • Carcinoma, Pancreatic Ductal / drug therapy*
  • Carcinoma, Pancreatic Ductal / mortality
  • Clinical Trials, Phase III as Topic
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / adverse effects
  • Deoxycytidine / analogs & derivatives*
  • Drug Administration Schedule
  • Humans
  • Multicenter Studies as Topic
  • Naphthoquinones / administration & dosage*
  • Naphthoquinones / adverse effects
  • Paclitaxel / administration & dosage*
  • Paclitaxel / adverse effects
  • Pancreatic Neoplasms / drug therapy*
  • Pancreatic Neoplasms / mortality
  • Progression-Free Survival
  • Randomized Controlled Trials as Topic
  • Young Adult

Substances

  • 130-nm albumin-bound paclitaxel
  • Albumins
  • Benzofurans
  • Naphthoquinones
  • napabucasin
  • Deoxycytidine
  • gemcitabine
  • Paclitaxel