NCT04925609

Brigatinib in Pediatric and Young Adult Patients With ALK+ ALCL, IMT or Other Solid Tumors

A Phase I/II Study of Brigatinib in Pediatric and Young Adult Patients With ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or Other Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Princess Maxima Center for Pediatric Oncology · Academic / Other
• Sex: All
• Age: 1 Year – 25 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Phase 1 part will be a dose escalation part using a rolling-6 design, aiming to accrue a minimum of 6 and a maximum of 18 evaluable patients in two dose-levels (and minus 1), at least 2/3 of included patients will be ≤18 years. Phase 2 will be the tumor cohort expansion part of the study to further evaluate the safety, tolerability, and clinical activity/efficacy of brigatinib as monotherapy in two tumor-specific cohorts: * Cohort B1: ALK+ IMT Planned sample size for Phase 2 is 12 patients with IMT. Patients who are included in the monotherapy Phase 1 IMT dose-escalation portion of the study will be included in the expansion cohort analysis if they receive the RP2D, and will count towards the total sample size of 12 patients. * Cohort B2: ALK+ ALCL Planned sample size for Phase 2 is 22 patients with ALCL. Patients who are included in the monotherapy Phase 1 ALCL dose-escalation portion of the study will be included in the expansion cohort analysis if they receive the RP2D, and will count towards the total sample size of 22 patients.

Conditions

• Anaplastic Large Cell Lymphoma, ALK-Positive
• Inflammatory Myofibroblastic Tumor
• Other Solid Tumor

Interventions

Type	Name	Description
DRUG	Brigatinib	Brigatinib is a second generation novel, orally administered, tyrosine kinase inhibitor (TKI) that potently inhibits activated variants of ALK and to a lesser extent ROS1.

Timeline

• Start date: 2022-08-18
• Primary completion: 2033-12-01
• Completion: 2033-12-01
• First posted: 2021-06-14
• Last updated: 2025-12-05

Locations

2 sites across 2 countries: France, Netherlands