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A clinical trial protocol paper discussing the BRIGHTER study

Mohamad Bassam Sonbol1, Tanios Bekaii-Saab1

  • 1Mayo Clinic Cancer Center, Mayo Clinic, Phoenix, AZ 85054, USA.

Future Oncology (London, England)
|January 4, 2018
PubMed

Insights

The BRIGHTER trial investigated napabucasin plus paclitaxel for advanced gastric cancer. This combination therapy did not improve overall survival in patients previously treated for this malignancy.

Area of Science:

  • Oncology
  • Gastroenterology
  • Clinical Trials

Background:

  • Napabucasin, a novel oral cancer stemness inhibitor, demonstrated promising preclinical and early clinical antitumor activity.
  • Advanced gastric and gastroesophageal junction adenocarcinoma has limited treatment options for previously treated patients.

Purpose of the Study:

  • To evaluate the efficacy and safety of combining napabucasin with paclitaxel in patients with advanced gastric and gastroesophageal junction adenocarcinoma.
  • To assess overall survival as the primary endpoint in a Phase III clinical trial.

Main Methods:

  • A multicenter, randomized, placebo-controlled, Phase III study (BRIGHTER trial).
  • Patients received weekly paclitaxel with either napabucasin or placebo in a 1:1 randomization.
  • The study included patients with previously treated advanced gastric and gastroesophageal junction adenocarcinoma.

Main Results:

  • The study failed to meet its primary endpoint of improving overall survival in the intention-to-treat population.
  • Ongoing analysis is evaluating secondary endpoints, including progression-free survival and objective response rate.
  • Safety of the combination therapy is also being assessed.

Conclusions:

  • Combining napabucasin with paclitaxel did not significantly improve overall survival in previously treated patients with advanced gastric and gastroesophageal junction adenocarcinoma.
  • Further analysis of secondary endpoints and biomarker-positive subpopulations may provide additional insights.
Keywords:
BBI608gastric cancernapabucasin

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