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NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)- A Phase 2 Subprotocol of Olaparib in Patients with Tumors Harboring Defects in DNA Damage Repair Genes

Status
Active
Cancer Type
Bone and Soft Tissue (including Sarcoma)
Brain Cancer
Ewing Sarcoma
Germ Cell Tumor
Liver/ Hepatoblastoma
Lymphoma
Neuroblastoma
Non-Hodgkin Lymphoma
Rhabdomyosarcoma
Unknown Primary
Trial Phase
Phase II
Eligibility
12 Months - 21 Years, Male and Female
Study Type
Treatment
NCD ID
NCT03233204
Protocol IDs
APEC1621H (primary)
APEC1621H
NCI-2017-00766
APEC1621H
Study Sponsor
Childrens Oncology Group

Summary

This phase II Pediatric MATCH trial studies how well olaparib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with defects in deoxyribonucleic acid (DNA) damage repair genes that have spread to other places in the body and have come back or do not respond to treatment. Olaparib 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 olaparib with advanced solid tumors (including central nervous system [CNS] tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor activating genetic alterations in the deleterious genetic alterations in the DNA damage repair (DDR) pathway.

SECONDARY OBJECTIVES:
I. To estimate the progression free survival in pediatric patients treated with olaparib with advanced solid tumors including non-Hodgkin lymphomas, CNS tumors, and histiocytosis that harbor deleterious genetic alterations in the DDR pathway.
II. To obtain information about the tolerability of olaparib in children and adolescents with relapsed or refractory cancer.
III. To provide preliminary estimates of the pharmacokinetics of olaparib in children and adolescents with relapsed or refractory cancer.

TERTIARY OBJECTIVES:
I. To explore approaches to profiling changes in tumor genomics over time through the evaluation of circulating tumor DNA.

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