PARP-Inhibitor Olaparib in children with solid tumors with HRR mutations
“A Phase 1, Open-label, Parallel Group Study to Investigate Olaparib Safety and Tolerability, Efficacy and Pharmacokinetics in Paediatric Patients with Solid Tumours (AZ Lynparza, D0816C00025)”
In this study, children and adolescents aged 6 months up to 18 years with relapsed or refractory non-CNS solid tumours are treated with Olaparib monotherapy. Olaparib specifically inhibits the enzyme PARP (Poly-[Adenosindiphosphat-Ribose]-Polymerase). The study therefore treats tumors whose genetic information show a deleterious or suspected deleterious germline or tumour HRR gene mutation and where the tumor has relapsed or progressed after standard therapy. Olaparib is taken orally over a 28-day cycle.
Inclusion of patients in Heidelberg has been possible since 28 May 2020.
- patients who are ≥6 months to <18 years of age at the screening visit
- Pathologically confirmed relapsed or refractory non-CNS solid tumours (excluding lymphoid malignancies), with a HRR deficiency, and for whom there are no standard treatment options. Eligible patients may include but not be limited to those with osteosarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, Ewing Sarcoma and neuroblastoma
- Karnofsky or Lansky > 50
For more information, see the Study Registry: The study is registered with the U.S. National Institutes of Health (ClinicalTrials.gov).
EudraCT-number: 2018-003355-38 (see EU clinical trial register)