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盐酸恩沙替尼胶囊已开展的临床研究

Clinical study progression for ensartinib

Clinicaltrials ID	Study title	Country	Sample size	Primary outcome
RECIST: Response Evaluation Criteria in Solid Tumors; MTD: maximum tolerated dose; NSCLC: non-small cell lung cancer; DLT: dose limited toxicity; RP2D: recommended phase 2 dose; PK: pharmacokinetic; ORR: objective response rate; iORR: intracranial objective response rate; PFS: progression-free survival.
NCT01625234	Phase 1/2 study of X-396, an oral alk inhibitor, in patients with ALK-positive NSCLC	U.S.	97	MTD
NCT02959619	Ensartinib in NSCLC patients with positive ALK	China	22	MTD, DLT, RP2D
NCT03510611	A study to investigate the food effect on the pharmacokinetics of ensartinib capsules in Chinese healthy volunteers	China	24	PKparameters, including Tmax, Cmax, AUC0-t, AUC0-∞, λz, T1/2
NCT03536481	Bioequivalency study of ensartinib capsules in healthy volunteers	China	74	PK parameters, including Cmax, AUC0-t, AUC0-∞, Tmax, T1/2, λz
NCT03804541	The absorption, metabolism and excretion of [14C]ensartinib in human	China	6	PK parameters, cumulative drug excretion, metabolite identification
NCT03215693	X-396 capsule in patients with ALK-positive NSCLC previously treated with crizotinib	China	160	ORR per RECIST 1.1 based on independent radiology review
NCT03753685	X-396 (Ensartinib) capsules in ALK-positive NSCLC patients with brain metastases	China	27	iORR based on investigator assessment according to RNAO-BM
NCT03213652	Ensartinib in treating patients with relapsed or refractory advanced solid tumors, non-hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic alterations (A pediatric match treatment trial)	U.S.	98	ORR
NCT02767804	eXalt3: study comparing X-396 (Ensartinib) to Crizotinib in ALK positive NSCLC patients	Global	360	PFS assessed by independent radiology review based on RECIST v.1.1