A call for global harmonization of phase I oncology trials: Results from two parallel, first-in-human phase I studies of DS-7423, an oral PI3K/mTOR dual inhibitor in advanced solid tumors conducted in the United States and Japan.
Yokota T, Bendell J, LoRusso P, Tsushima T, Desai V, Kenmotsu H, Watanabe J, Ono A, Murugesan B, Silva J, Naito T, Greenberg J, Kumar P, Wang Y, Jikoh T, Shiga R, Ho A, Gounder M. A call for global harmonization of phase I oncology trials: Results from two parallel, first-in-human phase I studies of DS-7423, an oral PI3K/mTOR dual inhibitor in advanced solid tumors conducted in the United States and Japan. Journal Of Clinical Oncology 2017, 35: 2536-2536. DOI: 10.1200/jco.2017.35.15_suppl.2536.Peer-Reviewed Original ResearchMaximum-tolerated doseBody mass indexAdvanced solid tumorsBody weightPhase IFrequent treatment-related adverse eventsSolid tumorsNon-small cell lung cancerGrade 3 lung infectionHuman Phase I StudyTreatment-related adverse eventsCorresponding phase IGrade 3 dehydrationGrade 3 fatigueGrade 3 stomatitisGrade 4 hyperglycemiaPhase 2 doseGrade 3 rashCell lung cancerPhase I studiesSquamous cell carcinomaPI3K/mTOR dual inhibitorPI3K/mTORMTOR dual inhibitorStable disease