biostudies-literatureUnknownShah MANCI NIH HHS<h4>Purpose</h4>To compare napabucasin (generator of reactive oxygen species) plus paclitaxel with paclitaxel only in patients with second-line advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.<h4>Experimental design</h4>In the double-blind, phase III BRIGHTER study (NCT02178956), patients were randomized (1:1) to napabucasin (480 mg orally twice daily) plus paclitaxel (80 mg/m2 i.v. weekly for 3 of 4 weeks) or placebo plus paclitaxel. The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and safety.<h4>Results</h4>Overall, 714 patients were randomized (napabucasin plus paclitaxel, n = 357; placebo plus paclitaxel, n = 357). 72.1% were male, 74.6% had gastricClinical cancer research : an official journal of the American Association for Cancer ResearchOF1-OF9https://www.ebi.ac.uk/biostudies/studies/S-EPMC9433958biostudies-literatureRandomized, Double-Blind, Placebo-Controlled Phase III Study of Paclitaxel ± Napabucasin in Pretreated Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.PMC9433958P30 CA016058Shen LBorodyansky LStarling NBang YJMetges JPHays JLShitara KFontaine MLee KWBrooks EMLi WXu RHVan Cutsem ELi CJLordick FXu BSturtz KOh CShah MAMuro KTebbutt NCTjulandin SfalseRandomized, Double-Blind, Placebo-Controlled Phase III Study of Paclitaxel ± Napabucasin in Pretreated Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.<h4>Purpose</h4>To compare napabucasin (generator of reactive oxygen species) plus paclitaxel with paclitaxel only in patients with second-line advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.<h4>Experimental design</h4>In the double-blind, phase III BRIGHTER study (NCT02178956), patients were randomized (1:1) to napabucasin (480 mg orally twice daily) plus paclitaxel (80 mg/m2 i.v. weekly for 3 of 4 weeks) or placebo plus paclitaxel. The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and safety.<h4>Results</h4>Overall, 714 patients were randomized (napabucasin plus paclitaxel, n = 357; placebo plus paclitaxel, n = 357). 72.1% were male, 74.6% had gastric2022-01-01T00:00:00Z2022 Jul2026-05-27T22:31:17.587Z2025-02-19T02:37:54.724ZS-EPMC94339583583378310.1158/1078-0432.CCR-21-4021