Antineoplastic Agents

All Drugs and Chemicals

Olaparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Olaparib capsules after standard breakfast

Olaparib capsules after high fat breakfast

400mg olaparib capsule formulation taken 30 minutes after allocated meal. 5-14 days between arms.

Allocated breakfast prior to dosing with 400mg olaparib capsules

Dietary Fasted

Dietary standard

Dietary High Fat

Anitra Fielding

Christian Rolfo

Wendy Bannister

This is a 2 part study for patients with solid tumours. The purpose of Part A is to measure the amount of olaparib or its breakdown products in the bloodstream for up to 72 hours after eating 3 different breakfasts (high calorie, regular and none). In Part B Patients can take olaparib capsules daily and study assessments will be recorded for 6 months (minimum). Treatment can continue for as long as the patient is benefitting. Throughout the study patients will be monitored for any side effects.

D081AC00001 Food Interaction With Olaparib Capsule in Patients With Solid Tumours

A Two-part, Randomised, Open-label, Multicentre, Phase I Study to Determine the Effect of Food on the Pharmacokinetics of Olaparib Following Single 400 mg Doses of the Capsule Formulation in Patients With Advanced Solid Tumours.

Rate and extent of absorption of olaparib following single-dose olaparib by assessment of maximum plasma olaparib concentration (Cmax) and time to reach maximum plasma concentration (tmax)

Rate and extent of absorption of olaparib following single-dose olaparib by assessment of area under the plasma concentration time curve from zero to the last measurable time point (AUC0-t)

Rate and extent of absorption of olaparib following single-dose olaparib by assessment of area under the plasma concentration time curve from zero to infinity (AUC)

Rate and extent of absorption of olaparib following single-dose olaparib by assessment of apparent clearance following oral administration (CL/F), apparent volume of distribution (Vz/F), terminal rate constant (λz), and terminal half-life (t½)

Assessment of adverse events (AEs), graded by CTCAE (v4.0), physical examination, vital signs (including BP and pulse), standard 12-lead ECG and evaluation of laboratory parameters (clinical chemistry, haematology, and urinalysis). Assessment of physical examination, vital signs, ECG and evaluation of laboratory parameters will occur at screening, on the day before dosing in each treatment period and 30 days after last dose.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
D081AC00001 Food Interaction With Olaparib Capsule in Patients With Solid Tumours	NCT01851265	Solid Tumours	Olaparib Dietary Fasted Dietary standar... Dietary High Fa...	18 Years - 130 Years	AstraZeneca
D081AC00001 Food Interaction With Olaparib Capsule in Patients With Solid Tumours	NCT01851265	Solid Tumours	Olaparib Dietary Fasted Dietary standar... Dietary High Fa...	18 Years - 130 Years	AstraZeneca

Spots Global Cancer Trial Database for oncology, cancer, tumour, neoplasm, anticancer drug, food effect, area under the curve, pharmacokinetics, olaparib, solid tumour, metabolites, drug availability