Abstract
Napabucasin is a novel oral first-in-class cancer stemness inhibitor. Preclinical and early phase clinical trials showed promising antitumor efficacy signals for napabucasin in a variety of malignancies. In this article, we describe the design and rationale for the now completed BRIGHTER trial, a multicenter, randomized, placebo-controlled, Phase III study designed to determine the efficacy and safety of combining napabucasin with paclitaxel in previously treated patients with advanced gastric and gastroesophageal junction adenocarcinoma (NCT02178956). Patients were randomized in a 1:1 fashion to receive weekly paclitaxel with either napabucasin or placebo. The study failed to achieve its primary end point of overall survival in the intention to treat population. Ongoing analysis of the secondary end points includes progression-free survival, objective response rate, disease control rate, the safety of the combination therapy and evaluation of efficacy in the biomarker-positive subpopulation.
Original language | English (US) |
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Pages (from-to) | 901-906 |
Number of pages | 6 |
Journal | Future Oncology |
Volume | 14 |
Issue number | 10 |
DOIs | |
State | Published - Apr 2018 |
Keywords
- BBI608
- gastric cancer
- napabucasin
ASJC Scopus subject areas
- Oncology
- Cancer Research