Spots Global Cancer Trial Database for D081AC00001 Food Interaction With Olaparib Capsule in Patients With Solid Tumours
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Trial Identification
Brief Title: D081AC00001 Food Interaction With Olaparib Capsule in Patients With Solid Tumours
Official Title: 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.
Study ID: NCT01851265
Conditions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Edegem, , Belgium
Research Site, Leuven, , Belgium
Research Site, Wilrijk, , Belgium
Research Site, Amsterdam, , Netherlands
Research Site, Maastricht, , Netherlands
Research Site, Glasgow, , United Kingdom
Research Site, Manchester, , United Kingdom
Contact Details
Name: Anitra Fielding
Affiliation: AstraZeneca Senior Research Physician
Role: STUDY_DIRECTOR
Name: Christian Rolfo
Affiliation: UZ Antwerpen
Role: PRINCIPAL_INVESTIGATOR
Name: Wendy Bannister
Affiliation: AstraZeneca Study Statistician
Role: STUDY_CHAIR
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