RecruitingPhase 1Phase 2NCT04925609

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


Sponsor

Princess Maxima Center for Pediatric Oncology

Enrollment

65 participants

Start Date

Aug 18, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 YearMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study is testing brigatinib (an ALK inhibitor targeted therapy) in children and young adults up to age 26 with cancers that have a specific genetic change in the ALK gene, including a type of lymphoma called ALK+ ALCL, inflammatory myofibroblastic tumors (IMT), and other solid tumors. **You may be eligible if:** - You are between 1 and under 26 years old and can swallow tablets - You have a confirmed diagnosis of cancer with an activating ALK genetic alteration - Your cancer has relapsed, is not responding to standard therapy, or cannot be surgically removed without severe consequences - Your performance status and organ function meet the required thresholds - You have not previously taken brigatinib (other ALK inhibitors are allowed) **You may NOT be eligible if:** - You are currently taking strong medications that interact with brigatinib - You have another concurrent primary cancer - You have significant heart problems (recent heart attack, heart block, or uncontrolled high blood pressure) - You have active hepatitis B, C, or HIV - You have conditions affecting drug absorption from the gut - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBrigatinib

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.


Locations(2)

Institut Gustave Roussy

Paris, France

Princess Máxima Center for Pediatric Oncology

Utrecht, Utrecht, Netherlands

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NCT04925609


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