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Phase I clinical study of oral olaparib in pediatric patients with refractory solid tumors: study protocol

Masatoshi Takagi1, Chitose Ogawa2, Yuki Aoki-Nogami2

  • 1Department of Pediatrics and Developmental Biology, Tokyo Medical and Dental University (TMDU), Yushima 1-5-45, Bunkyo-ku, Tokyo, 113-8519, Japan. m.takagi.ped@tmd.ac.jp.

BMC Pediatrics
|January 28, 2019
PubMed
Abstract

Insights

This study investigates olaparib, a poly(ADP-ribose) polymerase inhibitor, for recurrent pediatric solid tumors. The phase I trial evaluates safety, tolerability, and efficacy to determine a dose for further trials.

Area of Science:

  • Pediatric Oncology
  • Clinical Pharmacology
  • Cancer Therapeutics

Background:

  • Recurrent pediatric solid tumors like neuroblastoma and sarcoma lack standard chemotherapy.
  • Homologous recombination repair deficiencies are observed in some of these tumor cells.
  • Olaparib, a poly(ADP-ribose) polymerase inhibitor, is being investigated.

Purpose of the Study:

  • To evaluate the safety and tolerability of olaparib in pediatric patients.
  • To assess the efficacy of olaparib in refractory pediatric solid tumors.
  • To determine a recommended dose for phase II trials.

Main Methods:

  • Open-label, multicenter phase I clinical trial.
  • 3+3 dose escalation design with olaparib tablets (62.5, 125, 187.5 mg/m² b.i.d.).
  • Eligible patients aged 3-18 years with recurrent pediatric solid tumors.
  • Pharmacokinetic and pharmacodynamic analyses will be performed.

Main Results:

  • Results are pending as this is a protocol description.
  • Safety, tolerability, and efficacy data will be collected.

Conclusions:

  • This study aims to establish olaparib as a potential treatment for pediatric refractory solid tumors.
  • Findings will guide future clinical development of olaparib in this population.
Keywords:
ChemotherapyChildrenOlaparibPhase IPoly(ADP-ribose) polymeraseSolid tumor

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