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

NCT04925609 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-12-05

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Princess Maxima Center for Pediatric Oncology

    lead OTHER

Principal Investigators

  • Michel Zwaan, Prof · Princess Maxima Center for Pediatric Oncology in The Netherlands

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Year
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-18
Primary Completion
2033-12-31
Completion
2033-12-31

Countries

  • France
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04925609 on ClinicalTrials.gov