Tissue & blood collection from patients progressed on a PARP inhibitor
Research type
Research Study
Full title
A study to investigate the type and frequency of molecular alterations in the cancers of patients whose disease has undergone clinical progression while receiving treatment or following treatment with a PARP inhibitor for an approved indication
IRAS ID
309701
Contact name
Gillian Langford
Contact email
Sponsor organisation
Artios Pharma Ltd
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The purpose of the ART4215C004 study is to collect tumour and blood samples from patients who have been treated with PARP inhibitors and then analyse them. This analysis will help the understanding about the type and frequency of molecular alterations, such as changes to DNA, that can occur when a patient is treated with a PARP inhibitor. We aim to find out if there are changes that could result in patients responding to another drug known as a DNA Polymerase theta inhibitor. This would enable us to use a DNA Polymerase theta inhibitor in the future in a more personalised way, sparing patients unlikely to benefit from the side effects of a DNA Polymerase theta inhibitor, while ensuring those who may benefit, receive a DNA Polymerase theta inhibitor therapy. Both archival pre-PARP inhibitor tumour samples (if available) and new tumour biopsy samples will be collected. Blood samples will be taken alongside patients' routine bloods tests. A biopsy will be taken from an area where the tumour is increasing in size. Clinical information about patients' cancer will be recorded. The samples will be examined in the laboratory to learn more about markers that predict resistance to PARP inhibitor therapy. The study is planned to last for up to 2 years.
REC name
London - Central Research Ethics Committee
REC reference
22/PR/0114
Date of REC Opinion
8 Apr 2022
REC opinion
Further Information Favourable Opinion