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CompletedNCT03233204

Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial)

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
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
6 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
12 Months – 21 Years
Healthy volunteers
Not accepted

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 (advanced) and have come back (relapsed) or do not respond to treatment (refractory). Olaparib is an inhibitor of PARP, an enzyme that helps repair DNA when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy.

Detailed description

PRIMARY OBJECTIVE: 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. EXPLORATORY OBJECTIVE: 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. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

Conditions

Interventions

TypeNameDescription
DRUGOlaparibGiven PO

Timeline

Start date
2017-09-14
Primary completion
2023-03-31
Completion
2024-06-30
First posted
2017-07-28
Last updated
2024-12-11
Results posted
2024-04-25

Locations

113 sites across 2 countries: United States, Puerto Rico

Regulatory

Source: ClinicalTrials.gov record NCT03233204. Inclusion in this directory is not an endorsement.