{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["30(4)"],"submitter":["Chiang NJ"],"funding":["Innopharmax Inc"],"pubmed_abstract":["<h4>Background</h4>D07001-F4 is an absorption-enhanced oral gemcitabine developed in liquid formulation and adjusted to D07001-softgel capsules. We conducted 2 phase 1 studies to evaluate the dose-limiting toxicity (DLT), pharmacokinetics (PK), and maximum tolerated dose (MTD) of the 2 formulations of D07001 in patients with advanced solid tumors.<h4>Materials and methods</h4>Initially, patients received escalating doses (2-80 mg) of D07001-F4 thrice a week for 2 weeks, followed by 1-week rest. Since no DLT was observed in the phase 1 study, the phase 1b study was conducted with D07001-softgel capsules (dose range: 40-120 mg) in patients with refractory gastrointestinal malignancies. A bridging dose of 40 mg was administered in the phase 1b study to achieve an equivalent intake of 80 mg of"],"journal":["The oncologist"],"pagination":["oyaf051"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12012807"],"repository":["biostudies-literature"],"pubmed_title":["Phase I study of oral metronomic gemcitabine (D07001) in patients with advanced solid tumors."],"pmcid":["PMC12012807"],"pubmed_authors":["Chen LT","Bai LY","Lin CC","Chung WP","Su WC","Li CP","Chiang NJ","Chen MH","Chao Y","Wu SY","Hsu CH","Chen SH","Hao WH","Shan YS","Lee JH"],"additional_accession":[]},"is_claimable":false,"name":"Phase I study of oral metronomic gemcitabine (D07001) in patients with advanced solid tumors.","description":"<h4>Background</h4>D07001-F4 is an absorption-enhanced oral gemcitabine developed in liquid formulation and adjusted to D07001-softgel capsules. We conducted 2 phase 1 studies to evaluate the dose-limiting toxicity (DLT), pharmacokinetics (PK), and maximum tolerated dose (MTD) of the 2 formulations of D07001 in patients with advanced solid tumors.<h4>Materials and methods</h4>Initially, patients received escalating doses (2-80 mg) of D07001-F4 thrice a week for 2 weeks, followed by 1-week rest. Since no DLT was observed in the phase 1 study, the phase 1b study was conducted with D07001-softgel capsules (dose range: 40-120 mg) in patients with refractory gastrointestinal malignancies. A bridging dose of 40 mg was administered in the phase 1b study to achieve an equivalent intake of 80 mg of","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025 Apr","modification":"2026-07-03T03:24:55.111Z","creation":"2025-07-03T03:05:23.948Z"},"accession":"S-EPMC12012807","cross_references":{"pubmed":["40260994"],"doi":["10.1093/oncolo/oyaf051"]}}