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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 is a non-randomised, open label trial with one experimental arm run in three parts. Part 1 is a dose-confirmation phase to confirm the recommended phase 2 dose (RP2D) of alectinib. In Parts 2 and 3, participants will receive alectinib at the RP2D on Days 1-28 of each 28-day cycle. Alectinib will be administered twice-daily via oral capsule.