{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["10(6)"],"submitter":["Ueno M"],"funding":["Yakult Honsha"],"pubmed_abstract":["Purpose
Effective second-line chemotherapy options are limited in treating advanced biliary tract cancers (BTCs). Resminostat is an oral histone deacetylase inhibitor. Such inhibitors increase sensitivity to fluorouracil, the active form of S-1. In the phase I study, addition of resminostat to S-1 was suggested to have promising efficacy for pre-treated BTCs. This study investigated the efficacy and safety of resminostat plus S-1 in second-line therapy for BTCs.Methods
Patients were randomly assigned to receive resminostat or placebo (200 mg orally per day; days 1-5 and 8-12) and S-1 group (80-120 mg orally per day by body surface area; days 1-14) over a 21-day cycle. The primary endpoint was progression-free survival (PFS). Secondary endpoints comprised overall survival (O"],"journal":["Cancer medicine"],"pagination":["2088-2099"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC7957161"],"repository":["biostudies-literature"],"pubmed_title":["A randomized, double-blind, phase II study of oral histone deacetylase inhibitor resminostat plus S-1 versus placebo plus S-1 in biliary tract cancers previously treated with gemcitabine plus platinum-based chemotherapy."],"pmcid":["PMC7957161"],"pubmed_authors":["Furukawa M","Nemoto N","Fukutomi A","Komatsu Y","Nakai Y","Moriwaki T","Kobayashi S","Shimizu S","Tsuda M","Ishii H","Morizane C","Ueno M","Katanuma A","Negoro Y","Furuse J","Sakai D","Ikeda M","Makino K","Mizuno N","Kajiwara T","Muto M","Ozaka M","Tsuji A"],"additional_accession":[]},"is_claimable":false,"name":"A randomized, double-blind, phase II study of oral histone deacetylase inhibitor resminostat plus S-1 versus placebo plus S-1 in biliary tract cancers previously treated with gemcitabine plus platinum-based chemotherapy.","description":"Purpose
Effective second-line chemotherapy options are limited in treating advanced biliary tract cancers (BTCs). Resminostat is an oral histone deacetylase inhibitor. Such inhibitors increase sensitivity to fluorouracil, the active form of S-1. In the phase I study, addition of resminostat to S-1 was suggested to have promising efficacy for pre-treated BTCs. This study investigated the efficacy and safety of resminostat plus S-1 in second-line therapy for BTCs.Methods
Patients were randomly assigned to receive resminostat or placebo (200 mg orally per day; days 1-5 and 8-12) and S-1 group (80-120 mg orally per day by body surface area; days 1-14) over a 21-day cycle. The primary endpoint was progression-free survival (PFS). Secondary endpoints comprised overall survival (O","dates":{"release":"2021-01-01T00:00:00Z","publication":"2021 Mar","modification":"2025-04-20T02:30:22.194Z","creation":"2025-04-20T02:30:22.194Z"},"accession":"S-EPMC7957161","cross_references":{"pubmed":["33635605"],"doi":["10.1002/cam4.3813"]}}