NCT04774718

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ALK Fusion-positive Solid or CNS Tumors

Interventions

Type	Name	Description
DRUG	Alectinib	Participants will receive twice-daily alectinib capsules on Days 1-28 of each 28-day cycle

Timeline

• Start date: 2021-09-14
• Primary completion: 2032-02-28
• Completion: 2032-02-28
• First posted: 2021-03-01
• Last updated: 2026-04-06

Locations

33 sites across 12 countries: United States, Australia, Brazil, Canada, China, Denmark, France, Germany, Italy, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study