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

MB Sonbol, DH Ahn, D Goldstein, T Okusaka… - Future …, 2019 - Future Medicine
MB Sonbol, DH Ahn, D Goldstein, T Okusaka, J Tabernero, T Macarulla, M Reni, CP Li
Future Oncology, 2019Future Medicine
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 …
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.
Future Medicine