This phase II Pediatric MATCH trial studies how well ensartinib works in treating patients
with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic
alterations that have come back (recurrent) or do not respond to treatment (refractory) and
have spread to other places in the body (advanced). Ensartinib may stop the growth of tumor
cells by blocking some of the enzymes needed for cell growth.
I. To determine the objective response rate (ORR; complete response + partial response) in
pediatric patients treated with ensartinib with advanced solid tumors (including central
nervous system [CNS] tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor ALK
or ROS1 fusions or that harbor ALK missense mutations.
I. To estimate the progression free survival in pediatric patients treated with ensartinib
with advanced solid tumors (including CNS tumors), non-Hodgkin lymphomas or histiocytic
disorders that harbor ALK or ROS1 fusions or that harbor ALK missense mutations.
II. To obtain information about the tolerability of ensartinib in children with relapsed or
III. To provide preliminary estimates of the pharmacokinetics of ensartinib in children with
relapsed or refractory cancer.
I. To evaluate other biomarkers as predictors of response to ensartinib and specifically,
whether tumors that harbor different missense mutations or fusions (including the crizotinib
resistant F1174L ALK variant) will demonstrate differential response to ensartinib treatment.
II. To explore approaches to profiling changes in tumor genomics over time through evaluation
of circulating tumor deoxyribonucleic acid (DNA).
Patients receive ensartinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28
days for 2 years in the absence of disease progression or unacceptable toxicity.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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