A clinical trial protocol paper discussing the BRIGHTER study

Mohamad Bassam Sonbol, Tanios Bekaii-Saab

Research output: Contribution to journalArticlepeer-review

14 Scopus citations

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 languageEnglish (US)
Pages (from-to)901-906
Number of pages6
JournalFuture Oncology
Volume14
Issue number10
DOIs
StatePublished - Apr 2018

Keywords

  • BBI608
  • gastric cancer
  • napabucasin

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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