A worldwide study of an oral drug for patients with CML is now open in the UK.
This study is looking at how nilotinib affects CYP enzymes in chronic myeloid leukaemia (CML)
The study hopes to recruit 22 patients in Germany and the UK (Glasgow).
Please Note:
Single doses of midazolam would have no effect on his nilotinib treatment. This would only be a concern if both drugs were to be used together in the long term.
Aims:
This study will assess the interaction between the following two drugs:
* nilotinib, a tyrosine kinase inhibitor used to treat CML
and
*midazolam, a short-acting sedative used to calm anxiety or induce sleep or calm a patient e.g. before surgery.
The purpose of this research study is to identify how the study drug (nilotinib) works to switch on certain proteins in the body called CYP isoenzymes.
These isoenzymes breakdown and process drugs via a method called metabolism, which is a way that the human body gets rid of waste through urine and/or faeces.
Midazolam is a drug that is processed by one of these isoenzymes, called CYP3A.
This study aims to measure the effect of multiple doses of nilotinib and on how the body absorbs, processes and gets rid of (metabolizes) midazolam. This is called pharmacokinetics or PK for short.
Eligibility:
Eligible patients who have been diagnosed with CML (accelerated or chronic phase) and who are no longer showing benefit from at least one previous treatment, but have not been previously treated with nilotinib and are not currently being treated with nilotinib.
Eligible patients will receive nilotinib (400mg) twice daily and two separate doses of midazolam
over a 14 day period.
After 14 days, if patients are still benefiting from nilotinib treatment, they will be given the
option to enter an extension study and will receive nilotinib (400mg) twice daily for an additional 12
months.
If patients are still benefitting from treatment with nilotinib after the 12 month extension period,
patients will receive treatment with nilotinib as per their hospital’s standard of care.
If you would like further information about this study then please contact:
Professor Tessa Holyoake
Professor of Experimental Haematology
Director of the Paul O'Gorman Leukaemia Research Centre
Faculty of Medicine, University of Glasgow
21 Shelley Road
Gartnavel General Hospital, G12 0XB.
Email: t.holyoake@clinmed.gla.ac.uk