Evaluation of an assay to predict response to a FGFR-inhibitor: Ver 1
Research type
Research Study
Full title
Research protocol for the development and validation of a diagnostic assay to predict response to a fibroblast growth factor receptor inhibitor
IRAS ID
166685
Contact name
Jude O'Donnell
Contact email
Sponsor organisation
Almac Diagnostics
Duration of Study in the UK
3 years, 4 months, 29 days
Research summary
The objective of this research study is to develop and evaluate a diagnostic test that will predict response to a fibroblast growth factor receptor (FGFR)-inhibitor.
FGFRs are present in many types of normal and tumour cells. Overexpression of FGFRs, or aberrant regulation of their activity, has been implicated in many forms of human malignancies, including breast, lung, prostate, endometrial, gastric, and urothelial carcinoma. Therefore, targeting FGFRs in these cancers with a small molecule FGFR-inhibitor is an attractive strategy for the development of a novel cancer treatment.
A pharmaceutical company have developed an investigational FGFR-inhibitor which is currently being evaluated in Phase 1 clinical trials for the treatment of advanced solid tumours. The efficacy and safety of the FGFR-inhibitor for the treatment of metastatic or locally advanced urothelial cancer shall be established in a multi-centre international Phase 2 trial, scheduled to enrol patients in 2015-2016.
Studies have shown that people respond differently to treatment with drugs such as this FGFR-inhibitor. A diagnostic assay which could predict the likelihood of response to this agent prior to treatment would aid in the clinical management of patients with metastatic or locally advanced cancer, preventing unnecessary exposure of non-responders to the side-effects of the drug and reduce the cost burden to patients and healthcare providers.
In the clinical trial setting, the FGFRi diagnostic assay will be used to screen patients to determine if they are likely to respond to the FGFR-inhibitor. If the FGFRi assay predicts that the patient will respond, the patient will be enrolled onto either the Phase 1 or Phase 2 trial. The data generated from the Phase 2 trial will be used to evaluate the performance of the FGFRi assay i.e. determine if it can significantly and independently predict response to the FGFR-inhibitor.REC name
HSC REC A
REC reference
15/NI/0135
Date of REC Opinion
4 Aug 2015
REC opinion
Favourable Opinion