A Phase I, Open-label, Parallel Group Study to Investigate Olaparib Safety and Tolerability, Efficacy and Pharmacokinetics in Paediatric Patients with Solid Tumours

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507904-30-00

Acronym

D0816C00025

Enrollment

Registered

2024-10-08

Start date

2020-01-27

Completion date

2025-02-04

Last updated

2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

solid tumors

Brief summary

DLTs, RP2D, AEs/SAEs/deaths, discontinuation rate of olaparib treatment due to AEs throughout the study, clinical chemistry/haematology parameters, vital signs

Detailed description

PK parameters: CLss/F, Css,max, Css, min, tss,max, AUCss, dose normalised AUCss, AUC(0-8), AUC0-t, and dose normalised Css,max ORR, DCR and DoR as defined by Investigator-assessed RECIST v1.1, INRC, or RANO

Interventions

DRUGLynparza 100 mg film-coated tablets

DRUGAZD2281

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
DLTs, RP2D, AEs/SAEs/deaths, discontinuation rate of olaparib treatment due to AEs throughout the study, clinical chemistry/haematology parameters, vital signs	—

Secondary

Measure	Time frame
PK parameters: CLss/F, Css,max, Css, min, tss,max, AUCss, dose normalised AUCss, AUC(0-8), AUC0-t, and dose normalised Css,max ORR, DCR and DoR as defined by Investigator-assessed RECIST v1.1, INRC, or RANO	—

Countries

Denmark, France, Hungary, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026