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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Conditions

Solid Tumours

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Anitra Fielding

Affiliation: AstraZeneca Senior Research Physician

Role: STUDY_DIRECTOR

Name: Christian Rolfo

Affiliation: UZ Antwerpen

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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