Use of FGFRi assay to determine eligibility for trial enrolment
Research type
Research Study
Full title
Validation and use of a clinical trial assay to determine molecular eligibility for enrolment onto clinical trials evaluating the safety and effectiveness of an investigational FGFR-inhibitor
IRAS ID
231635
Contact name
Jude O'Donnell
Contact email
Sponsor organisation
Almac Diagnostics
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
A panel of oncogenic driver mutations within the FGFR2/3 genes have been identified as being potentially associated with response to a fibroblast growth factor (FGFR) inhibitor (FGFRi). Almac has previously developed and analytically validated a clinical trial assay (CTA) to identify these mutations and the assay has been used previously to determine molecular eligibility for enrolment onto a Phase 2 clinical trial (REC reference number 15/NI/0135).
The pharmaceutical company that have developed the FGFRi now wish to further evaluate its safety and efficacy in a Phase 1b/2 and separately in a Phase 3 clinical trial. The FGFRi CTA will be used to determine the molecular eligibility for enrolment on these clinical trials i.e. the patients must be positive for at least one of the mutations detected by the assay to be considered eligible for trial enrolment.
A slight modification to the the FGFRi CTA design has been made and as such the analytical validity of the assay will be re-established following this design modification for its intended use as a CTA to determine enrolment onto these clinical trials.
Following completion of analytical validation, and subject to relevant approvals, the FGFRi CTA is intended to be used to determine the molecular eligibility of patients for enrolment onto the upcoming clinical trials.
Almac's FGFRi CTA will be used for a limited period to determine molecular eligibility for enrolment onto these clinical trials, as the pharmaceutical sponsor intends to transition to an alternative in vitro diagnostic (IVD) assay once this assay is ready for use.
As such, the data generated from use of Almac's FGFRi CTA in the trial will not be used to establish the clinical validity/performance of the CTA. However, the data generated by Almac's FGFRi CTA may contribute to performance evaluation of the subsequent IVD via a bridging study.REC name
London - City & East Research Ethics Committee
REC reference
17/LO/2089
Date of REC Opinion
8 Dec 2017
REC opinion
Favourable Opinion