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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 or Impaired Kidney Function

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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 or Impaired Kidney Function

Official Title: An Open-label, Non-randomised, Multicentre, Comparative, Phase I Study of the Pharmacokinetics, Safety and Tolerability of Olaparib Following a Single Oral 300 mg Dose to Patients With Advanced Solid Tumours and Normal Renal Function or Renal Impairment

Study ID: NCT01894256

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 renal impairment compared to patients with normal renal function; Part B will allow eligible study 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, Brussels (Jette), , Belgium

Research Site, Edegem, , Belgium

Research Site, Leuven, , Belgium

Research Site, Liege, , Belgium

Research Site, Wilrijk, , Belgium

Research Site, Herlev, , Denmark

Research Site, København Ø, , Denmark

Research Site, Bordeaux, , France

Research Site, Dijon, , France

Research Site, Amsterdam, , Netherlands

Research Site, Maastricht, , Netherlands

Research Site, Newcastle Upon Tyne, , United Kingdom

Research Site, Surrey, , 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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