A Phase I, Open-label, Parallel Group Study to Investigate Olaparib Safety and Tolerability, Efficacy and Pharmacokinetics in Paediatric Patients With Solid Tumours
This is a phase I study to find out whether olaparib is safe and well tolerated when administerd to children and adolescents with solid tumors. Children and adolescents from 6 months to < 18 years of age with relapsed or refractory solid or primary CNS tumors (excluding lymphoid malignancies) are eligible for this trial.
Olaparib acts as an inhibitor of the enzyme PARP (Poly-[Adenosindiphosphat-Ribose]-Polymerase), an enzyme involved in DNA repair. Therefore, in this clinical trial patients whose genetic information show a deleterious or suspected deleterious germline or tumor HRR gene mutation are treated. Olaprib is taken orally over a 28-days cycle.