Last updated on August 2020

Investigating Safety Tolerability Efficacy and PK of Olaparib in Paediatric Patients With Solid Tumours


Brief description of study

A study to find out whether olaparib is safe and well tolerated when administered to children and adolescents with solid tumours.

Detailed Study Description

A Phase I open-label, multicentre study to determine the RP2D of olaparib monotherapy in the paediatric population, and to evaluate the safety, tolerability, PK, PDx and preliminary efficacy of olaparib monotherapy in paediatric patients from 6 months to <18 years of age at enrolment, with relapsed or refractory solid or primary CNS tumours (excluding lymphoid malignancies) for whom there are no standard treatment options. It is anticipated that eligible patients fulfilling all of the inclusion criteria and none of the exclusion criteria, will include but will not be limited to those with osteosarcoma, rhabdomyosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, Ewing Sarcoma, neuroblastoma, medulloblastoma and glioma.

Clinical Study Identifier: NCT04236414

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København Ø, Denmark
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Marseille, France
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Toulouse, France
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Villejuif, France
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Heidelberg, Germany
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Mainz A. Rhein, Germany
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Petah Tikva, Israel
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Seoul, Korea, Republic of
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Songpa-gu, Korea, Republic of
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Barcelona, Spain
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Esplugues De Llobregat (Barc), Spain
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Birmingham, United Kingdom
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Glasgow, United Kingdom
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Leeds, United Kingdom
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Sutton, United Kingdom
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København Ø, Denmark
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Recruitment Status: Open


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