Patient Recruitment Initiated in Glasgow
Amid Pancreatic Cancer Awareness month, the Precision-Panc initiative has been granted approval by the NHS Greater Glasgow and Clyde Health Board to begin initial recruitment of patients to the Precision-Panc Master Protocol at Glasgow Royal Infirmary. The team at Glasgow Royal Infirmary have spent the last year modifying the patient pathway and developing endoscopic biopsy techniques so that patients can provide samples for the Precision Panc study as part of their routine diagnostic care – making it easier for patients to be able to enter these studies without additional tests.
“This is an extraordinary opportunity to transform the therapeutic options and treatment pathway for pancreatic cancer patients. It is one of the first projects in the UK to bring genetic sequencing into the clinic in order to direct the care of pancreatic cancer patients.” – Professor Andrew Biankin, Chief Investigator, University of Glasgow.
Simultaneously, the first of three planned PRIMUS (Pancreatic Cancer Individualized Multi-arm Umbrella Study) clinical trials has also opened for recruitment at the Beatson West of Scotland Cancer Centre. Glasgow is the first site to receive this approval. Additional sites across the UK and Northern Ireland are currently in set up and are expected to receive approval in early 2018.
The Master Protocol serves as the entry point to Precision-Panc and is the first step for patients to be recruited before enrolling onto a suitable clinical trial downstream. As part of the protocol, each patient must undergo tumour biopsy to obtain material that will then be subjected to molecular profiling at the Glasgow Precision Oncology Laboratory within the University of Glasgow. The results may be used to facilitate matching patients to the most appropriate available clinical trial. Linking clinical data with the patient’s unique molecular profiling data will enable rapid new discoveries and enhance delivery of precision medicine to current and future patients. The Precision-Panc platform aims to facilitate drug development, and ultimately to new drug approval allowing access of novel drugs to all patients and furthermore improving survival in all patients with pancreatic cancer.
“Precision-Panc is an unprecedented platform that brings in key stakeholders of pancreatic cancer including clinicians, researchers, and industry partners through coordinated efforts, to advance precision medicine in pancreatic cancer care.” – Dr David Chang, Translational Chief Investigator, University of Glasgow/Glasgow Royal Infirmary.
Currently three clinical trials, funded in part by Cancer Research UK, are planned which will recruit a total of 658 patients under the Precision-Panc umbrella with scope to add more trials in the future. Each clinical trial will test new and combinations of drugs in specific types of patients. PRIMUS-001 is an adaptive Phase II/III study with an integrated biomarker evaluation in patients with metastatic disease and is currently open for recruitment in Glasgow only. PRIMUS-002 will aim to define biomarkers of therapeutic responsiveness in the neoadjuvant setting and is set to open in 2018. Celgene International supports both of these studies. Additionally, PRIMUS-003, supported by AstraZeneca, is using an immunotherapy approach and is also currently recruiting patients in the metastatic setting. If appropriate, As part of the Precision-Panc Master Protocol, patients may also be helped onto other suitable clinical trials that are already up and running across the UK.
“The entire team in Glasgow are delighted to be able to start recruiting patients to Precision-Panc, and are excited by the possibility that this platform will start to deliver real improvements in outcomes for patients with pancreatic cancer.” – Professor Colin McKay, Principal Investigator at Glasgow Royal Infirmary.
Precision-Panc is a collaborative effort between clinicians, scientists and various other experts with key partnerships between the NHS GGC Biorepository, Molecular Genetics West of Scotland Genetic Services based at the Queen Elizabeth University Hospital, the Glasgow Precision Oncology Laboratory at the Wolfson Wohl Cancer Research Center, University of Glasgow, Beatson Institute for Cancer Research, and the CRUK Clinical Trials Unit formed to carry out tissue acquisition, storage, processing, testing and analysis. It is an ambitious programme of research that seeks to uncover the molecular profile of individual patients with pancreatic cancer, to learn more about the disease and to pave the way for patients entering clinical trials in a way that matches their tumour biology to the type of treatment.
It is composed of a network of clinical trials aimed to find the right trial for the right patient matching patients to treatments most likely to work for their type of pancreatic cancer. It is designed to be comprehensive with a faster turnaround time than traditional clinical trials while advancing discovery through science and ultimately changing patient outcomes in this disease.
Earlier this year, Cancer Research UK committed £10 million investment to support Precision Panc. “This ambitious project marks a new era for pancreatic cancer. We believe that Precision-Panc will reshape how we approach treatment development. Cancer Research UK is determined to streamline research, to find the right clinical trial for all pancreatic cancer patients and to ensure laboratory discoveries have patient benefit.” says Dr Ian Walker, Director of Clinical Research at Cancer Research UK.
Other support and funding has been received from the University of Glasgow, Celgene, Wellcome Trust, Chief Scientist’s Office, Scottish Genomes Partnership, MRC/ESPRC Glasgow Molecular Pathology Node, NHS Scotland, The Howat Foundation, Pancreatic Cancer UK, The Scottish Precision Medicine Ecosystem/Stratified Medicine Scotland Innovation Centre, AstraZeneca/MedImmune, NCRI and ECMC.
Anna Jewell, Director of Operations at Pancreatic Cancer UK notes “It’s incredibly exciting to see the first stages of this game-changing effort to change the future for people with pancreatic cancer. The clinical trial in Glasgow will provide a much-needed new treatment option for eligible patients with a disease which sadly has so few treatments available, and we would encourage patients to ask their doctor or consultant if they think this trial would be suitable for them. The overall aim of PRECISION Panc is to make precision medicine a reality for more people with pancreatic cancer through building up knowledge that will ultimately allow clinicians to match patients with the most suitable treatment or clinical trial for them. We are proud to be a part of this vitally important work for everyone affected by this tough disease.”
Patients interested in participating in the Precision-Panc project should discuss options with their treating clinicians in the first instance.
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