This is the first study to open through the ECMC Combinations Alliance which launched last year. AstraZeneca is the first pharmaceutical industry partner to join the alliance, which aims to increase patient access to trials of potential new cancer treatments, combining molecularly-targeted experimental drugs developed and owned by the company with standard chemotherapy, radiotherapy and other new experimental drugs.
The Phase Ib/IIa clinical trial will be led from the Glasgow Cancer Research UK and Scottish Health Department’s Experimental Cancer Medicine Centre (ECMC) and the Cancer Research UK Glasgow Clinical Trials Unit at The Beatson West of Scotland Cancer Centre.
The trial is open for patients that have higher than usual amounts of a protein called fibroblast growth factor receptor-2 (FGFR2).
FGFR2 signaling controls cell growth and survival – and is often faulty in cancer cells, causing them to grow and divide beyond control. Studies have shown that patients with higher than normal levels of the FGFR2 gene tend to respond poorly to standard treatment approaches. It is hoped that adding AZD4547 will improve response to treatment by blocking FGFR2.
Chief investigator, Professor Jeff Evans at the University of Glasgow, said: “I’m delighted to see the launch of this trial, which will find out if a new combination of drugs could be used to treat patients with advanced stomach or oesophageal cancer.
“There are very few treatment options for advanced forms of these diseases and there’s an urgent need to develop new therapies.
“We hope this trial will be an important step forward in finding a more effective treatment approach – ultimately improving survival from these diseases – and we’ll be watching the trial results with great interest.”
Patients will receive the experimental treatment AZD4547 alongside the conventional chemotherapy treatment of a drug combination of cisplatin and capecitabine – also called ‘CX’.
In the initial part of the study, to find the correct dose of AZD4547 to give with the chemotherapy drugs, patients with other types of tumour will also be eligible to take part. This may lead on to potential studies in other tumour types in the future.
AstraZeneca is providing the investigational drug AZD4547 and additional funding. Cancer Research UK’s Drug Development Office is also providing support.
Andrew Foxley, clinical programme director for AZD4547 at AstraZeneca, said: “AstraZeneca is committed to pushing new boundaries in oncology therapy and delivering medicines to broaden the options available to cancer patients and make a meaningful difference to their lives. We are pleased to collaborate with others through efforts such as the ECMC Combinations Alliance to help speed up the delivery of high-quality, targeted medicines to patients.”
Dr Ian Walker, head of alliance management at Cancer Research UK’s DDO, said: “The alliance enables UK patients to take part in important clinical trials of potential new treatment approaches – such as this trial for advanced stomach and oesophageal cancer – and will provide a huge boost to UK research in developing exciting new combination therapies.
“Our aim is to develop cross-company agreements to provide access to a larger number of potential combinations to help us beat cancer.
“We will take the model we’ve established with AstraZeneca forward by actively looking for additional partners who are interested in collaborating with us.”
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Notes to editors
Pre-clinical experiments have shown that tumours with high levels of this gene are very sensitive to AZD4547 and the drug has been able to reduce the size of the tumour.
CX is often used to treat advanced cancer of the stomach and oesophagus that have spread and cannot be removed by an operation.
The first part of this trial will aim to establish the correct dose of AZD4547 to give in combination with chemotherapy. The second part of the trial will investigate whether combining AZD4547 with CX is better than treatment with CX alone in patients with advanced stomach or oesophagus cancers whose cells have unusually high FGFR-2 levels.