Lynparza Olaparib
A Phase I, Open-label, Parallel Group Study to Investigate Olaparib Safety and Tolerability, Efficacy and Pharmacokinetics in Paediatric Patients With Solid Tumours
Recruitment stopped
Summary
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.
Main inclusion criteria
- Children and adolescents from 6 months to < 18 years of age at 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 oder Lansky > 50
Sponsor
Astra Zeneca