biostudies-literatureUnknown30(4)Chiang NJInnopharmax Inc<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 ofThe oncologistoyaf051https://www.ebi.ac.uk/biostudies/studies/S-EPMC12012807biostudies-literaturePhase I study of oral metronomic gemcitabine (D07001) in patients with advanced solid tumors.PMC12012807Chen LTBai LYLin CCChung WPSu WCLi CPChiang NJChen MHChao YWu SYHsu CHChen SHHao WHShan YSLee JHfalsePhase I study of oral metronomic gemcitabine (D07001) in patients with advanced solid tumors.<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 of2025-01-01T00:00:00Z2025 Apr2026-07-03T03:24:55.111Z2025-07-03T03:05:23.948ZS-EPMC120128074026099410.1093/oncolo/oyaf051