The trial will test an experimental drug from AstraZeneca in patients with advanced oesophago-gastric cancer – a disease for which no well-established standard treatments exist.
The Phase I national trial is the second study to open through the Experimental Cancer Medicine Centre (ECMC) Combinations Alliance initiative, which launched last year to run trials of the newest and most exciting combinations of cancer medicine for UK patients.
Cancer Research UK’s DDO is working in partnership with AstraZeneca and the ECMC network to provide strategic oversight and funding to the trial. AstraZeneca is providing the investigational drug AZD8931 and additional funding. Oxford University is sponsoring and managing the trial with support from the Oxford NIHR Biomedical Research Centre.
The trial will investigate whether combining the experimental drug AZD8931 with existing chemotherapy drugs, called oxalipatin and capecitabine, is more effective than treatment with chemotherapy alone.
Survival rates for patients with these cancers remain low, with less than 20 per cent of patients in England surviving for five years. Around 12,600 people in the UK die from these cancers each year.
Chief Investigator, Dr Anne Thomas, a clinical reader in the Department of Cancer Studies and Molecular Medicine at the University of Leicester and consultant oncologist at Leicester Royal Infirmary, said: “It’s wonderful news that this trial is opening, testing a promising new way to treat oesophago-gastric cancer.
“There still isn’t a standard treatment plan for these diseases and patients are often diagnosed at a late stage when there are fewer options available. So there’s an urgent need to innovate, and develop new and effective treatments.
“The opening of this trial brings fresh hope for the future and we’ll follow the results with great interest.”
Dr Ian Walker, head of alliance management at Cancer Research UK’s DDO, said: “We’re delighted to see the Combinations Alliance with AstraZeneca is now opening a second trial – demonstrating the value and importance of such collaborative partnerships. This trial is particularly important as oesophago-gastric cancers remain difficult to treat. It’s clear that without the Combinations Alliance this trial may never have taken place and this is an excellent example of what can be achieved through such collaborations.
“By combining molecularly-targeted experimental drugs developed and owned by the company with other treatments, we’re able to increase the options for patients and, we hope, save more lives in the future.”
AstraZeneca is the first pharmaceutical industry partner to join the initiative. The Combinations Alliance will be expanded to include more partners and establish cross-company agreements, providing patients with access to a larger number of potential combinations.
AZD8931 works by blocking a family of proteins called erbB which are found on the surface of cancer cells in the oesophagus and stomach. The erbB proteins tell cancer cells to carry on dividing. Turning off this signal will help kill the cancer cells.
Graham Richmond, project leader for AZD8931 at AstraZeneca, said: “It is increasingly evident that strategic partnerships such as this are highly valuable in determining the broader utility of new experimental compounds such as AZD8931 for patients with oesophago-gastric cancer. Through collaborations, we are able to explore the potential of combination therapies for cancer, building on our strong oncology heritage and at the same time tapping into external expertise.”
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Notes to editors
*Fluoropyrimidine-based and platinum-based combinations with or without a third drug (epirubicin or docetaxel) are the most commonly used combinations in Europe and the USA.
The trial will take place at three UK centres: Leicester Royal Infirmary, Churchill Hospital Oxford, and Belfast City Hospital. Professor Mark Middleton, is the lead clinician for the Oxford arm of the trial. Professor Mark Middleton is also funded by the NIHR Oxford Biomedical Research Centre. Dr Martin Eatock is the lead clinician for the Belfast arm of the trial.
The first part of this trial will aim to establish the correct dose of AZD8931 to give in combination with chemotherapy. The second part of the trial will compare those receiving AZD8931 plus chemotherapy, with those receiving chemotherapy alone.
Age-standardised five-year relative survival rate, adults (aged 15-99), England 2005-2009.