NCT01851265

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Solid Tumours

Interventions

Type	Name	Description
DRUG	Olaparib	400mg olaparib capsule formulation taken 30 minutes after allocated meal. 5-14 days between arms.
OTHER	Dietary Fasted	Allocated breakfast prior to dosing with 400mg olaparib capsules
OTHER	Dietary standard	Allocated breakfast prior to dosing with 400mg olaparib capsules
OTHER	Dietary High Fat	Allocated breakfast prior to dosing with 400mg olaparib capsules

Timeline

• Start date: 2013-07-04
• Primary completion: 2013-10-18
• Completion: 2017-06-06
• First posted: 2013-05-10
• Last updated: 2017-08-28

Locations

7 sites across 3 countries: Belgium, Netherlands, United Kingdom