iMYC
Research type
Research Study
Full title
Proof-of-concept study of ibrutinib in c-MYC and HER2 amplified gastrooesophageal carcinoma
IRAS ID
192575
Contact name
Ian Chau
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Eudract number
2015-005525-39
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Some cancers of the oesophagus and stomach express excessive copies of either the cMYC gene, the HER2 gene or both. These genes may potentially contribute to the growth and spread of cancer.
Ibrutinib is a drug that is already used in the treatment of certain cancers of the immune system. There is preclinical evidence that it shows activity against gastric and stomach cancer cells over-expressing cMYC and HER2 genes.
The iMYC study will assess the activity of ibrutinib in cancers of the oesophagus and stomach which over-express these genes and which have previously been treated with standard chemotherapies.
Any anti-cancer activity seen will be measured and correlated with metabolic changes on FDG-PET scan, changes in DNA and circulating tumour cells in the blood, and molecular changes in the cancer itself through the use of optional repeat tumour biopsies. If an effect is seen it could provide justification for further research in this group of patients.
Patients will be eligible if they have advanced cancer of the oesophagus or stomach and have been treated with at least one line of prior therapy. The study will be conducted at the Royal Marsden Hospital at its Sutton and Chelsea sites. It will involve an initial group of up to 17 patients. Screening, recruitment and follow up will last for 3 years in total.
Patients wishing to take part must consent to having their cancer biopsied to test for cMYC and HER2 amplification, as well as a number of imaging and blood tests. There are optional further tumour biopsies whilst on study. Patients will be treated with ibrutinib until progression of their disease or unnacceptable toxicity.
REC name
London - Riverside Research Ethics Committee
REC reference
16/LO/0545
Date of REC Opinion
19 May 2016
REC opinion
Further Information Favourable Opinion