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. 2018 Jul 20;14:1247–1252. doi: 10.2147/TCRM.S147381

Table 1.

Entrectinib clinical trials

Study Patient population Study design Dose and schedule
ALKA-372-0012 Locally advanced or metastatic cancer targeting NTRK1, NTRK2, NTRK3, ROS1, or ALK molecular alterations Phase I basket 100–1,800 mg/m2
Schedule A (n=19): fasted, 4 days on and 3 days off for 21 of 28 days
Schedule B (n=29): fed, continuous daily dosing for 28 days
Schedule C (n=6): fed, 4 days on and 3 days off for 28 days
STARTRK-12 Locally advanced or metastatic cancer targeting NTRK1/2/3, ROS1, or ALK molecular alterations Phase I basket 100–1,800 mg/m2
Fed, continuous daily dosing for 28 days (n=65)
STARTRK-236 Solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion Phase II basket 600 mg
Fed, continuous daily dosing for 28 days
STARTRK-NG26 Children with recurrent or refractory solid tumors and primary CNS tumors, with or without TRK1/2/3, ROS1, or ALK fusions Phase I/Ib 250 mg/m2
Fed, continuous daily dosing for 28 days

Abbreviations: ALK, anaplastic lymphoma kinase; NTRK, neurotrophic tyrosine kinase; ROS1, ROS proto-oncogene 1; CNS, central nervous system.