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Brief Title: Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment
Official Title: An Open-label, Non-randomised, Multicentre, Comparative, Phase I Study to Determine the Pharmacokinetics, Safety and Tolerability of Olaparib Following a Single Oral 300 mg Dose to Patients With Advanced Solid Tumours and Normal Hepatic Function or Mild or Moderate Hepatic Impairment
Study ID: NCT01894243
Brief Summary: This is a 2-part study in patients with advanced solid tumours. Part A will investigate the PK of olaparib in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function; Part B will allow patients with mild or moderate hepatic impairment or normal hepatic function continued access to olaparib after the PK phase and will provide additional safety data.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, Brno, , Czechia
Research Site, Bordeaux Cedex, , France
Research Site, Bordeaux, , France
Research Site, Dijon, , France
Research Site, Grenoble cedex 9, , France
Research Site, Lyon Cedex 8, , France
Research Site, Paris Cedex 13, , France
Research Site, Seoul, , Korea, Republic of
Research Site, Amsterdam, , Netherlands
Research Site, Maastricht, , Netherlands
Research Site, London, , United Kingdom
Research Site, Sutton, , United Kingdom
Name: Anitra Fielding
Affiliation: AstraZeneca Senior Research Physician
Role: STUDY_DIRECTOR
Name: Christian Rolfo
Affiliation: UZ Antwerpen
Role: PRINCIPAL_INVESTIGATOR