Spots Global Cancer Trial Database for Study to Assess the Effect of Rifampicin (CYP Inducer) on Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours
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Trial Identification
Brief Title: Study to Assess the Effect of Rifampicin (CYP Inducer) on Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours
Official Title: A Non-randomised, Open-label, Sequential, Multicentre, Two-part, Phase I Study to Assess the Effect of Rifampicin, a CYP Inducer, on the Pharmacokinetics of Olaparib Following Oral Dosing of a Tablet Formulation in Patients With Advanced Solid Tumours
Study ID: NCT01929603
Conditions
Study Description
Brief Summary: This is a 2-part study in patients with advanced solid tumours. Part A will investigate the effect of rifampicin on the PK parameters of olaparib in patients; Part B will allow patients 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, Edegem, , Belgium
Research Site, Gent, , Belgium
Research Site, Wilrijk, , Belgium
Research Site, Amsterdam, , Netherlands
Research Site, Maastricht, , Netherlands
Contact Details
Name: Anitra Fielding
Affiliation: AstraZeneca Senior Research Physician
Role: STUDY_DIRECTOR
Name: Luc Dirix
Affiliation: GZA Ziekenhuizen Campus Sint-Augustinus
Role: PRINCIPAL_INVESTIGATOR
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