D5160C00008 - Phase I, Open Label, PK, Advanced Solid Tumour (Hepatic)
Research type
Research Study
Full title
An Open-label, Non-randomised, Multicentre, Comparative, Phase I Study to Determine the Pharmacokinetics, Safety and Tolerability of AZD9291 following a Single Oral Dose to Patients with Advanced Solid Tumours and Normal Hepatic Function or Mild or Moderate Hepatic Impairment
IRAS ID
159400
Contact name
Elizabeth Ruth Plummer
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2014-001515-39
Research summary
This is a 2 part study in patients with advanced solid tumours and normal hepatic (liver) function or mild or moderate hepatic impairment (liver not functioning normally).
The study is being carried out to measure levels of AZD9291 in the blood (up to 22 days after taking the AZD9291) in patients with normal or impaired hepatic (liver) function (Part A ). This study will help determine whether impaired liver function affects the body’s ability to break down and excrete AZD9291, and whether patients with liver problems need to receive a different dose.
The study will also provide more information on how well AZD9291 is tolerated in patients with liver impairment compared to patients with normal liver function (Part B). Participants will be in Part B for at least 6 months (unless they withdraw, their disease progresses, the Investigator believes they are no longer benefitting from treatment, or they stop taking AZD9291 for another reason). Part B will end 6 months after the last patient begins Part B.
An optional part of this study involves the collection of a blood sample for genetic (DNA) research. The potential participant will sign a separate consent form if they wish to take part in this optional component of the study.
This study is Open-label which means that both the participant and investigators/ site study team will know which treatment the participant is receiving. The study also is Non-Randomised which means all participants will receive the same treatment.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
14/SC/1192
Date of REC Opinion
1 Sep 2014
REC opinion
Favourable Opinion