D5160C00013 - Phase I, Open Label, EGFRm positive NSCLC (Inducer)
Research type
Research Study
Full title
A Phase I, Open-Label, Non-Randomised, Multicentre Study to Assess the Effect of Rifampicin (a CYP3A4 Inducer) on the Pharmacokinetics of AZD9291 in Patients with EGFRm Positive NSCLC whose disease has Progressed on an EGFR TKI
IRAS ID
161856
Contact name
Elizabeth Ruth Plummer
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2014-001525-32
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). Unfortunately, after a period of treatment with EGFR TKIs, tumours will no longer respond to this treatment. AZD9291 hopes to benefit those patients whose cancer has progressed despite previous treatment with EGFR TKIs.
Part A is the PK (Pharmacokinetic) phase to determine how the body absorbs, breaks down and removes AZD9291 through levels of study drug in the blood and how a second medicine, Rifampicin, (which is known to affect the way some medications are handled in the body) affects the way AZD9291 is handled when taken in a fasted state. Participants will be in Part A for 78 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/ 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/1259
Date of REC Opinion
10 Oct 2014
REC opinion
Favourable Opinion