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. 2022 Mar 24;27(7):536–e553. doi: 10.1093/oncolo/oyab080
Disease Advanced cancer/solid tumor only
Stage of Disease/Treatment Metastatic/advanced
Prior Therapy More than 2 prior regimens
Type of Study Phase I, modified continual reassessment method using a Bayesian logistic regression model with escalation with overdose control principle
Primary Endpoints Maximum tolerated dose, recommended phase II dose
Secondary Endpoints Pharmacodynamics, safety
Investigator’s Analysis Due to dose-limiting skeletal muscle toxicities and the lack of efficacy at the maximum tolerated dose of 100 mg, further enrollment was stopped