Title: “A Phase I/II, Open-Label, Multicenter, Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors for Whom Prior Treatment Has Proven to be Ineffective or for Whom There is No Satisfactory Treatment Available.”
This study will evaluate the safety, pharmacokinetics, and efficacy of alectinib in children and adolescents 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.
Alectinib is a selective ALK- and RET-kinase inhibitor. Inhibiting these proteins inhibits tumor growth and leads to death of tumor cells.
Participants will receive twice-daily alectinib orally as capsules on Days 1-28 of each 28-day cycle.
