{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"submitter":["Shah MA"],"funding":["NCI NIH HHS"],"pubmed_abstract":["<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 gastric"],"journal":["Clinical cancer research : an official journal of the American Association for Cancer Research"],"pagination":["OF1-OF9"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9433958"],"repository":["biostudies-literature"],"pubmed_title":["Randomized, Double-Blind, Placebo-Controlled Phase III Study of Paclitaxel ± Napabucasin in Pretreated Advanced Gastric or Gastroesophageal Junction Adenocarcinoma."],"pmcid":["PMC9433958"],"funding_grant_id":["P30 CA016058"],"pubmed_authors":["Shen L","Borodyansky L","Starling N","Bang YJ","Metges JP","Hays JL","Shitara K","Fontaine M","Lee KW","Brooks EM","Li W","Xu RH","Van Cutsem E","Li CJ","Lordick F","Xu B","Sturtz K","Oh C","Shah MA","Muro K","Tebbutt NC","Tjulandin S"],"additional_accession":[]},"is_claimable":false,"name":"Randomized, Double-Blind, Placebo-Controlled Phase III Study of Paclitaxel ± Napabucasin in Pretreated Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.","description":"<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 gastric","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Jul","modification":"2026-05-27T22:31:17.587Z","creation":"2025-02-19T02:37:54.724Z"},"accession":"S-EPMC9433958","cross_references":{"pubmed":["35833783"],"doi":["10.1158/1078-0432.CCR-21-4021"]}}