Dasatinib treatment in advanced cancer with specific genetic mutations
Research type
Research Study
Full title
Phase II trial of dasatinib in subjects with advanced cancers harbouring DDR2 mutation or inactivating B-RAF mutation
IRAS ID
101475
Contact name
Fiona Blackhall
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2011-003128-11
Clinicaltrials.gov Identifier
Research summary
Lung cancer is still the leading cause of cancer-related death. In advanced lung cancer chemotherapy is only partially effective, delaying progression of the disease in a small proportion of patients. Recently, cancer subtypes have been identified by particular mutations (genetic changes in tumour cells) which may make them responsive to particular treatments. This has permitted physicians to select ??targeted?? drugs for these cancers. The search for such mutations is greatly accelerating progress in the study of cancer. The study will investigate this approach for subjects with lung cancer, whose cancer has a mutation in the DDR2 gene or an inactivating mutation in the B-RAF (iB-RAF) gene, to evaluate whether treatment with the study drug, dasatinib, is of benefit to them. Dasatinib is already licensed to treat leukaemia and has previously been used in clinical trials in lung cancer patients. Subjects who meet all entry criteria and consent to taking part will undergo physical examinations, blood tests, chest x-rays, heart function tests and CT or MRI scans. Subjects will be continually monitored and their treatment will be stopped if they don??t respond to treatment or are unable to tolerate any side effects. Subjects will receive treatment in the study for at least 2 years or for longer if they are responding to therapy. A maximum of 65 patients worldwide are expected to participate, about 16 of whom would be in the UK. Globally the study is due to start in May 2012. Subjects will be grouped according to their mutation (DDR2 or BRAF) in each group, if at least 3 subjects of the first 12 show a response to treatment, recruitment will continue to a maximum of 25. The study is funded by Bristol-Myers Squibb, Inc. and will be conducted initially in 5 UK hospitals ?? Manchester, Cambridge, Edinburgh, London, and Newport.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
12/NW/0504
Date of REC Opinion
16 Jul 2012
REC opinion
Further Information Favourable Opinion