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APEC1621H 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

Primary Aims:

To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with olaparib with advanced solid tumors (including 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 Aims:

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.

To obtain information about the tolerability of olaparib in children and adolescents with relapsed or refractory cancer.

To provide preliminary estimates of the pharmacokinetics of olaparib in children and adolescents with relapsed or refractory cancer.

Exploratory Aims

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

Protocol Number: 111706-H
Phase: Phase II
Applicable Disease Sites: Any Site
Brain and Nervous System
Non-Hodgkin's Lymphoma
Drugs Involved: Olaparib
Principal Investigator: Richard Drachtman M.D.
Scope: National
Therapies Involved: Chemotherapy single agent systemic
Participating Institutions:
  • Rutgers Cancer Institute of New Jersey
    • Principal Investigator
      • Richard Drachtman M.D.
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria. For additional information on this trial or other available clinical trials please contact the research nurse.

For further information about clinical trials, please contact us at 732-235-7356.