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

Study identifier:D0816C00025

ClinicalTrials.gov identifier:NCT04236414

EudraCT identifier:2018-003355-38

CTIS identifier:N/A

Recruiting

Official Title

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

Medical condition

Solid tumours

Phase

Phase 1

Healthy volunteers

No

Study drug

Olaparib

Sex

All

Estimated Enrollment

30

Study type

Interventional

Age

0 Years - 18 Years

Date

Study Start Date: 14 Jan 2020
Estimated Primary Completion Date: 31 Oct 2024
Estimated Study Completion Date: 31 Oct 2024

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria