D5160C00019 - Phase I, Open Label, PK, EGFRm+ NSCLC (Rosuvastatin)
Research type
Research Study
Full title
A Phase I, Open-Label, Non-Randomised, Multicentre Study to Assess the Effect of AZD9291 on the Pharmacokinetics of Rosuvastatin (a Sensitive BCRP Substrate) in Patients with EGFRm Positive NSCLC whose disease has Progressed on an EGFR TKI
IRAS ID
168678
Contact name
Ruth Plummer
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2014-003179-42
Duration of Study in the UK
1 years, 10 months, 0 days
Research summary
This is a 2 part study in patients with non small cell lung cancer (NSCLC) that is caused by changes in a protein called Epidermal Growth Factor Receptor (EGFR). This protein can be altered by a change (mutation) to its genetic code. Patients who have NSCLC with a EGFR mutation can be treated by specific drugs called EGFR tyrosine kinase inhibitors (EGFR TKIs).
Part A is the PK (Pharmacokinetic) phase to determine how taking AZD9291 affects the way a second medicine, rosuvastatin (used to treat high cholesterol), is absorbed, broken down and removed from the body, by checking the levels of the drugs in the blood, when taken in a fasted state. This will help to establish how AZD9291 interacts with this type of medication. Each participant will receive AZD9291 80 mg once a day for 31 days (Days 4 to 34) and will also receive a single oral dose of rosuvastatin on Days 1 and 32. Participants will be in Part A for approximately 35 days (following screening).
Part B will determine how well AZD9291 is tolerated by allowing participants further access to AZD9291 after the PK phase, until such time as their disease progresses, the Investigator believes they are no longer benefitting from treatment, or they stop taking AZD9291 for another reason. Participants will be in Part B for at least 12 months (unless they withdraw).
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/ research 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
North East - Tyne & Wear South Research Ethics Committee
REC reference
14/NE/1253
Date of REC Opinion
12 Jan 2015
REC opinion
Further Information Favourable Opinion