A PHASE I/II, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF ALECTINIB IN PEDIATRIC PATIENTS WITH ALK FUSION-POSITIVE SOLID OR CNS TUMORS FOR WHOM PRIOR TREATMENT HAS PROVEN TO BE INEFFECTIVE OR FOR WHOM THERE IS NO SATISFACTORY STANDARD TREATMENT AVAILABLE

ALK fusion-positive extracranial solid or primary CNS tumors who have progressed following prior treatment or who have no satisfactory treatment available

1. Incidence of dose-limiting toxicities (DLTs) assessed during the first cycle of study treatment, 2. Incidence and severity of adverse events, with severity determined according to the NCI-CTCAE v5.0, as well as changes from baseline in physical findings, targeted vital signs, clinical lab test results and ECG parameters, 3. Plasma concentrations of alectinib and its metabolites (M4) at specified timepoints, 4. Confirmed objective response rate (ORR) as determined by blinded independent central review

1. Confirmed ORR as determined by the investigator, 2. Duration of response (DOR), 3. Time to response (TTR), 4. Clinical benefit rate (CBR), 5. Progression-free survival (PFS) as determined by blinded independent central review and by the investigator, 6. Overall survival (OS)

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