Spots Global Cancer Trial Database for To Determine the Effect of Food on the Pharmacokinetics of Olaparib and the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation in Patients With Advanced Solid Tumours
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Trial Identification
Brief Title: To Determine the Effect of Food on the Pharmacokinetics of Olaparib and the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation in Patients With Advanced Solid Tumours
Official Title: A Randomised, Open-label, Three-part, Phase I Study to Determine the Effect of Food on the Pharmacokinetics of Olaparib and to Provide Data on the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation in Patients With Advanced Solid Tumours
Study ID: NCT01921140
Conditions
Study Description
Brief Summary: This is a 3 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 and the effect of olaparib on QT interval following a single oral dose of olaparib tablets. Part B will determine the effect of olaparib on the QT interval following multiple oral dosing. Part C will allow patients continued access to olaparib tablets and will provide additional safety data collection.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Brussels, , Belgium
Research Site, Leuven, , Belgium
Research Site, Liege, , Belgium
Research Site, Herlev, , Denmark
Research Site, København Ø, , Denmark
Research Site, Maastricht, , Netherlands
Research Site, Nijmegen, , Netherlands
Research Site, Utrecht, , Netherlands
Research Site, London, , United Kingdom
Research Site, Manchester, , United Kingdom
Research Site, Newcastle-Upon-Tyne, , United Kingdom
Research Site, Surrey, , United Kingdom
Contact Details
Name: Anitra Fielding
Affiliation: AstraZeneca Sponsor Research Physician
Role: STUDY_DIRECTOR
Name: Ruth Plummer, Prof
Affiliation: Northern Centre for Cancer Care, Newcastle Upon Tyne Hospitals
Role: PRINCIPAL_INVESTIGATOR
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