Spots Global Cancer Trial Database for To Assess Safety and Effect of Olaparib on the Pharmacokinetics of Anastrozole, Letrozole & Tamoxifen, and Their Effect on Olaparib, in Patients With Advanced Solid Cancer
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Trial Identification
Brief Title: To Assess Safety and Effect of Olaparib on the Pharmacokinetics of Anastrozole, Letrozole & Tamoxifen, and Their Effect on Olaparib, in Patients With Advanced Solid Cancer
Official Title: An Open-Label, Non-randomised, Parallel Group, Multicentre, Phase I Study to Assess the Safety and Effect of Olaparib at Steady State on the Pharmacokinetics of the Anti-hormonal Agents Anastrozole, Letrozole and Tamoxifen at Steady State, and the Effect of the Anti-hormonal Agents on Olaparib, Following Administration in Patients With Advanced Solid Cancer
Study ID: NCT02093351
Conditions
Study Description
Brief Summary: This is an open-label 2-part Phase I study in patients with advanced solid tumours. Part A of the study (mandatory) will assess the effect of olaparib on the pharmacokinetics (PK) of anastrozole, letrozole and tamoxifen and vice versa; Part B will allow patients (if eligible) continued access to olaparib after the PK phase and will provide additional safety data.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Brussels, , Belgium
Research Site, Edegem, , Belgium
Research Site, Gent, , Belgium
Research Site, Leuven, , Belgium
Research Site, Liège, , Belgium
Research Site, Wilrijk, , Belgium
Research Site, Herlev, , Denmark
Research Site, Bordeaux, , France
Research Site, Amsterdam, , Netherlands
Research Site, Utrecht, , Netherlands
Research Site, London, , United Kingdom
Research Site, Manchester, , United Kingdom
Research Site, Newcastle Upon Tyne, , United Kingdom
Research Site, Sutton, , United Kingdom
Contact Details
Name: Tsveta Milenkova
Affiliation: AstraZeneca
Role: STUDY_DIRECTOR
Name: Ruth Plummer
Affiliation: Sir Bobby Robson Cancer Trials Research Centre
Role: PRINCIPAL_INVESTIGATOR
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