A clinical trial to test a drug which may stop bladder cancers becoming resistant to chemotherapy is being launched by Cancer Research UK’s Centre for Drug Development and the Experimental Cancer Medicines Centre (ECMC) network, today.
The new phase I/II trial – called SPIRE – will test a drug called guadecitabine (SGI-110)* in combination with chemotherapy to see if it can treat the disease and stop patients becoming resistant.
The first part of the trial – which will run from Cancer Research UK’s Southampton Clinical Trials Unit and open in centres across the UK – will give small doses of guadecitabine to between three and 36 patients with advanced solid tumours, including bladder, lung, stomach and oesophageal cancers, to ensure the drug is safe and to find the most effective dose.
The drug will then be tested in 20 bladder cancer patients to see how well it works against the cancer.
Guadecitabine is a type of DNA methyltransferase inhibitor – a drug that blocks molecules that can modify DNA. In cancer these molecules turn off genes that should be on, causing resistance to chemotherapy.
The researchers hope that giving the drug alongside the chemotherapy will block this resistance.
Each year around 10,400 people are diagnosed with bladder cancer in the UK and more than 5,200 people die from the disease**.
Dr Simon Crabb, trial lead from the Southampton ECMC, said: “Advanced bladder cancer can be a difficult disease to treat and we desperately need to improve our treatment options. Our trial offers a new approach to tackling resistant bladder cancers and there’s promising lab research to suggest it might benefit patients.
“We hope our trial is a success and prompts larger clinical trials to evaluate the benefits of this approach for the thousands of bladder cancer patients in the UK.”
The trial was set up through the Combinations Alliance – an initiative that supports research into drug combinations to bring cancer patients more treatment options.
Nigel Blackburn, Cancer Research UK’s director of drug development, said: “Studying drug resistance in cancer helps us get one step ahead of the disease, allowing us to target its defences. We’ve seen a lot of drug combinations in the news recently and we hope that this approach will help in bladder cancer where there are few options for patients.”
* Guadecitabine is a drug from Astex Pharmaceuticals, Inc.
** Based on annual average number of new cases and deaths from bladder cancer (ICD10 C67) in the UK between 2012 and 2014.