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

Status
Active
Cancer Type
Lymphoma
Neuroblastoma
Non-Hodgkin Lymphoma
Unknown Primary
Trial Phase
Phase II
Eligibility
12 Months - 21 Years, Male and Female
Study Type
Treatment
NCT ID
NCT03213652
Protocol IDs
APEC1621F (primary)
APEC1621F
NCI-2017-01243
APEC1621F
Study Sponsor
Childrens Oncology Group

Summary

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 or do not respond to treatment and have spread to other places in the body. Ensartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Objectives

PRIMARY OBJECTIVES:
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.

SECONDARY OBJECTIVES:
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 refractory cancer.
III. To provide preliminary estimates of the pharmacokinetics of ensartinib in children with relapsed or refractory cancer.

TERTIARY OBJECTIVES:
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).

OUTLINE:
Patients receive ensartinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

Treatment Sites in Georgia

Aflac Cancer and Blood Disorders Center of Children’s at Egleston


1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

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