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

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

January 14, 2020

Primary Completion Date

February 4, 2025

Study Completion Date

February 4, 2025

Conditions
Solid Tumours
Interventions
DRUG

Olaparib

Patients will receive a single dose of olaparib on Day 1, followed by initiation of bd continuous dosing from Day 2 onwards. Olaparib should be taken at the same time each day (morning and evening), approximately 12 hours apart with one glass of water. The tablets should be swallowed whole and not chewed, crushed, dissolved or divided. 25 and 100 mg tablet strengths available for ages ≥3 to \<18 years. AAF available for ≥0.5 to \<6 years; The AAF is a sprinkle capsule formulation, available in dose strengths of 15 mg and 19.5 mg. The sprinkle capsules contain 1.5 mg granules which are to be dispersed onto a food vehicle prior to dosing.

Trial Locations (10)

2100

Research Site, København Ø

28009

Research Site, Madrid

31300

Research Site, Toulouse

59000

Research Site, Lille

69120

Research Site, Heidelberg

94805

Research Site, Villejuif

03080

Research Site, Seoul

05505

Research Site, Seoul

G51 4TF

Research Site, Glasgow

SM2 5PT

Research Site, Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY