Status: Recruiting
Brigatinib in Pediatric and Young Adult Patients With ALK+ ALCL, IMT or Other Solid Tumors
This is an open-label, phase I-II dose-escalation and expansion study designed to define the recommended dose of brigatinib as monotherapy in pediatric and young adult patients with ALK+ ALCL, IMT or other solid tumors and to evaluate the pharmacokinetics (PK), (long-term) safety, and efficacy of brigatinib in these children.
Participants needed: 65
Trial details
Phase: Phase 1, Phase 2Age: 1-25Biological sex: AllType: InterventionalSponsor: Princess Maxima Center for Pediatric OncologyUpdated: Dec 5, 2025Locations: 2
Eligibility criteria
Patients must be 1 and < 26 years of age at the time of enrollment, and able to... [+26]
Patients receiving systemic treatment with strong or moderate CYP3A inhibitors o... [+10]