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

Study identifier:D0816C00005

ClinicalTrials.gov identifier:NCT01894243

EudraCT identifier:2013-002246-37

CTIS identifier:N/A

Study Complete

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

Medical condition

Solid tumours

Phase

Phase 1

Healthy volunteers

No

Study drug

Olaparib tablet dosing

Sex

All

Actual Enrollment

31

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 13 Mar 2014
Primary Completion Date: 01 Dec 2016
Study Completion Date: 30 Mar 2017

Study design

Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Other

Verification:

Verified 01 Jun 2020 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria