A drug drug interaction study of INC280 with digoxin and rosuvastatin
Research type
Research Study
Full title
A phase 1 multicentre open label single sequence drug drug interaction study to assess the effect of INC 280 on the pharmacokinetics of digoxin and rosuvastatin in patients with C-Met dysregulated advanced solid tumours
IRAS ID
194499
Contact name
Lisa Tran
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2015-002219-13
Duration of Study in the UK
1 years, 1 months, 29 days
Research summary
It is well known that there are different types of cancer, set apart by the presence, absence, or changing levels of certain “markers” in the tumour. Some of these different types of cancer respond differently to different treatments. .INC280 is an oral investigational drug that is called a ‘targeted’ medicine. This means it
targets particular processes, which may not be working properly in the cancer cells in the body (called dysregulation) . INC280 is currently studied in various forms of cancers with cMET dysregulation.This is a clinical research study to find out if the drug INC280 has an effect on the pharmacokinetics (i.e., how drugs are processed in the body and how the body gets rid of drugs) of 2 commonly used medications (digoxin and rosuvastatin) in patients who have cMET dysregulated advanced solid tumours. Such studies are often referred to as “drug-drug interaction” studies, and the results of this study will be used to tell whether it is safe for INC280 to be taken at the same time as these (or similar) drugs, and if INC280 is safe and has beneficial effects in people who have a cMET-dysregulated advanced solid tumours.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
16/YH/0021
Date of REC Opinion
31 Mar 2016
REC opinion
Further Information Favourable Opinion