About the Study

Cancer with ALK or ROS1 mutations: A study of ensartinib as treatment for tumors

This study is for: • Patients who have enrolled in APEC1621SC • Who are between the ages of 12 months old and 21 years old • Have been diagnosed with cancer that is relapsed (has come back) or is refractory (has not responded to earlier treatment) • The cancer also must have a specific genetic change, also called a mutation, in a gene called ALK or ROS1 • Are able to swallow pills The medicine, ensartinib, has been shown to block the growth of cancer cells with ALK or ROS1 in laboratory experiments. Early studies with ensartinib have been conducted in adults. The study drug is taken by mouth for up to 24 months. The goal of this study is to find what effects ensartinib has on a child's tumor, any side effects it may cause, and to learn more about the pharmacology of the medication.

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Full Study Name: APEC1621F NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)- Phase 2 Subprotocol of Ensartinib in Patients with Tumors Harboring ALK or ROS1 Genomic Alterations