A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors

Phase 1/2 Recruiting 42 enrolled Hoffmann-La Roche

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2021-09-14
Primary completion: 2032-02-28
Completion: 2032-02-28

Publications

Bagchi A, Chiang J, Pinto S, Dhanda S, Gajjar A. Infant-Type Hemispheric Gliomas: A Review of Clinical, Radiologic, Histopathologic, and Molecular Features. J Natl Compr Canc Netw. 2025 Nov;23(11):e257064. doi: 10.6004/jnccn.2025.7064.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alectinib	Small molecule	—	Oral

Indications

No indication recorded.