At a glance
ClinicalIndex Comparison Record- ✓Age 1 to <26 years at enrollment
- ✓Able to swallow brigatinib tablets with minimum weight 10 kg (Phase 1: ≤18 years old only)
- ✓Confirmed histologic diagnosis of cancer at baseline
- ✓Activating ALK aberration confirmed by local laboratory with central confirmation required
- ✕Systemic treatment with strong or moderate CYP3A inhibitors or inducers within 14 days or 5 half-lives (whichever less) prior to first dose
- ✕Another concurrent primary malignancy
- ✕Clinically significant cardiovascular disease including MI/unstable angina within 6 months, heart block, significant arrhythmias, or uncontrolled hypertension
- ✕Planned non-protocol chemotherapy, radiation therapy, investigational agent, or immunotherapy during study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Brigatinib for Anaplastic Large Cell Lymphoma, ALK-Positive and 2 related conditions. Currently recruiting, targeting 65 participants across 2 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
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.