Evaluation of an assay to predict response to a PARP 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 poly (ADP-ribose) polymerase (PARP) inhibitor
IRAS ID
215210
Contact name
Laura Nelson
Contact email
Sponsor organisation
Almac Diagnostics Ltd
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
The objective of this research study is to develop and evaluate a diagnostic test that will predict response to a poly(ADP-ribose) polymerase (PARP) inhibitor (PARPi).
A pharmaceutical company have acquired a PARPi which exerts cytotoxic effects through the inhibition of PARP1 and PARP2 catalytic activity. Recent studies have shown that PARP inhibition exhibits an enhanced cytotoxic effect in cancers with established DNA repair defects. Previous studies suggest that PARP inhibition may be useful for treatment of patients with metastatic cancer particularly those harbouring DNA repair pathway deficiencies. Development of a diagnostic assay to predict the likelihood of response to this agent prior to treatment could 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 cost burden to patients and healthcare providers.
In the clinical trial setting the PARPi diagnostic assay (PARPi CTA) will be used to screen patients to determine if they are likely to respond to the PARPi. A Phase two study will enrol diagnostic-positive patients, whereas a Phase 3 study will enrol unselected patients (ie diagnostics positive and negative patients). The data generated from these clinical trials will be used to evaluate the performance of the PARPi assay i.e. determine if it can significantly and independently predict response to the PARP inhibitor.
REC name
London - City & East Research Ethics Committee
REC reference
16/LO/2103
Date of REC Opinion
22 Nov 2016
REC opinion
Favourable Opinion