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NCI-COG Pediatric MATCH (Molecular Analysis For Therapy Choice)- Phase 2 Subprotocol of Ly3023414 in Patients with Solid Tumors

Status
Active
Cancer Type
Bone and Soft Tissue (including Sarcoma)
Brain Cancer
Ewing Sarcoma
Germ Cell Tumor
Liver/ Hepatoblastoma
Lymphoma
Neuroblastoma
Unknown Primary
Trial Phase
Phase II
Eligibility
12 Months - 21 Years, Male and Female
Study Type
Treatment
NCD ID
NCT03213678
Protocol IDs
APEC1621D (primary)
APEC1621D
NCI-2017-01249
APEC1621D
Study Sponsor
Childrens Oncology Group

Summary

This phase II Pediatric MATCH trial studies how well PI3K / mTOR inhibitor LY3023414 works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with TSC or PI3K / MTOR mutations that have spread to other places in the body and have come back or do not respond to treatment. PI3K / mTOR inhibitor LY3023414 may stop the growth of cancer 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 PI3K/mTOR inhibitor LY3023414 (LY3023414) with advanced solid tumors, non-Hodgkin lymphomas or central nervous system (CNS) tumors that harbor TSC loss of function mutations, that harbor other PI3K/MTOR activating mutations, and if efficacy is observed in a MATCHed cohort, in patients that lack mutations in the PI3K/MTOR pathway.

SECONDARY OBJECTIVES:
I. To estimate the progression free survival in pediatric patients treated with LY3023414 with advanced solid tumors, non-Hodgkin lymphomas or CNS tumors that harbor TSC loss of function mutations, that harbor other PI3K/MTOR activating mutations, or if efficacy is observed in a MATCHed cohort, that lack mutations in the PI3K/MTOR pathway.
II. To obtain information about the tolerability of LY3023414 in children with relapsed or refractory cancer.
III. To characterize the pharmacokinetics of LY3023414 in children with recurrent or refractory cancer.
IV. If efficacy is observed in a MATCHed cohort, to obtain preliminary information on the response rate to LY3023414 in patients that lack mutations in the PI3K/MTOR pathway.

TERTIARY OBJECTIVES:
I. To increase knowledge of the genomic landscape of relapsed pediatric solid tumors and lymphomas and identify potential predictive biomarkers (other than the genomic alteration for which study treatment was assigned) using additional genomic, transcriptomic, and proteomic testing platforms.
II. To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA).
III. To evaluate the frequency and mechanism of biallelic loss of function, and evaluate the expression of TSC1, TSC2, and PTEN in subjects who enroll with a loss of function mutation in one of these genes.

OUTLINE: This is a dose-escalation study.

Patients receive PI3K/mTOR inhibitor LY3023414 orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unexpected toxicity.

After completion of study treatment, patients are followed up periodically.
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