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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Advanced Malignant Solid Neoplasm
  • Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma
  • Ann Arbor Stage IV Childhood Non-Hodgkin Lymphoma
  • Central Nervous System Neoplasms
  • Ependymoma
  • Glioma
  • Hepatoblastoma
  • Histiocytosis
  • Histiocytosis, Langerhans-Cell
  • Low Grade Glioma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Malignant Glioma
  • Medulloblastoma
  • Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Nervous System Neoplasms
  • Neuroblastoma
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Osteosarcoma
  • Recurrence
  • Recurrent Childhood Central Nervous System Neoplasm
  • Recurrent Childhood Ependymoma
  • Recurrent Childhood Malignant Germ Cell Tumor
  • Recurrent Childhood Non-Hodgkin Lymphoma
  • Recurrent Childhood Rhabdomyosarcoma
  • Recurrent Childhood Soft Tissue Sarcoma
  • Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Recurrent Glioma
  • Recurrent Hepatoblastoma
  • Recurrent Langerhans Cell Histiocytosis
  • Recurrent Malignant Solid Neoplasm
  • Recurrent Medulloblastoma
  • Recurrent Neuroblastoma
  • Recurrent Osteosarcoma
  • Refractory Childhood Malignant Germ Cell Tumor
  • Refractory Ependymoma
  • Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Refractory Glioma
  • Refractory Hepatoblastoma
  • Refractory Langerhans Cell Histiocytosis
  • Refractory Malignant Glioma
  • Refractory Malignant Solid Neoplasm
  • Refractory Medulloblastoma
  • Refractory Neuroblastoma
  • Refractory Non-Hodgkin Lymphoma
  • Refractory Osteosarcoma
  • Refractory Primary Central Nervous System Neoplasm
  • Refractory Rhabdomyosarcoma
  • Refractory Soft Tissue Sarcoma
  • Rhabdoid Tumor
  • Rhabdomyosarcoma
  • Sarcoma
  • Sarcoma, Ewing
  • Wilms Tumor

NCT number NCT03233204
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Active, not recruiting
Phase Phase 2
Start date September 14, 2017
Completion date September 22, 2024

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