{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["3(2)"],"submitter":["Moore KN"],"funding":["Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA"],"pubmed_abstract":["<h4>Background</h4>Sapanisertib (TAK-228) is an investigational, orally available, potent and highly selective mTORC1/2 inhibitor demonstrating promise in numerous malignancies. This phase I study (NCT02412722) evaluated the safety, tolerability, pharmacokinetics and antitumour activity of single-agent TAK-228 (milled capsules), administered daily (QD) or weekly (QW) and in combination with paclitaxel in patients with advanced solid tumours. Pharmacokinetic comparisons of milled versus unmilled TAK-228 and the impact of food were also investigated.<h4>Methods</h4>Patients were enrolled to receive: TAK-228 QD, TAK-228 3 days/week plus paclitaxel 80 mg/m<sup>2</sup> days 1, 8, 15 (TAK-228+P) or TAK-228 QW (all 28-day cycles); starting TAK‑228 doses were 4, 6 and 20 mg, respectively.<h4>Resul"],"journal":["ESMO open"],"pagination":["e000291"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC5812400"],"repository":["biostudies-literature"],"pubmed_title":["Phase I study of the investigational oral mTORC1/2 inhibitor sapanisertib (TAK-228): tolerability and food effects of a milled formulation in patients with advanced solid tumours."],"pmcid":["PMC5812400"],"pubmed_authors":["Neuwirth R","Bauer TM","Zohren F","Patel MR","Patel C","Falchook GS","Chowdhury S","Enke A","Moore KN"],"additional_accession":[]},"is_claimable":false,"name":"Phase I study of the investigational oral mTORC1/2 inhibitor sapanisertib (TAK-228): tolerability and food effects of a milled formulation in patients with advanced solid tumours.","description":"<h4>Background</h4>Sapanisertib (TAK-228) is an investigational, orally available, potent and highly selective mTORC1/2 inhibitor demonstrating promise in numerous malignancies. This phase I study (NCT02412722) evaluated the safety, tolerability, pharmacokinetics and antitumour activity of single-agent TAK-228 (milled capsules), administered daily (QD) or weekly (QW) and in combination with paclitaxel in patients with advanced solid tumours. Pharmacokinetic comparisons of milled versus unmilled TAK-228 and the impact of food were also investigated.<h4>Methods</h4>Patients were enrolled to receive: TAK-228 QD, TAK-228 3 days/week plus paclitaxel 80 mg/m<sup>2</sup> days 1, 8, 15 (TAK-228+P) or TAK-228 QW (all 28-day cycles); starting TAK‑228 doses were 4, 6 and 20 mg, respectively.<h4>Resul","dates":{"release":"2018-01-01T00:00:00Z","publication":"2018","modification":"2026-06-08T03:23:33.192Z","creation":"2026-06-08T03:14:07.651Z"},"accession":"S-EPMC5812400","cross_references":{"pubmed":["29464110"],"doi":["10.1136/esmoopen-2017-000291"]}}