Cancer Research UK’s Drug Development Office has launched a clinical trial* to test an experimental drug in patients with advanced (Stage IV) pancreatic cancer – one of the most difficult cancers to treat.
Around 60 patients with advanced pancreatic cancer will be recruited for the first Phase I/IIclinical trial of a drug called MK-0752** in this disease. MK-0752 will be administered in combination with the standard treatment for advanced pancreatic cancer, gemcitabine*** .
Trials have already tested the effects of the drug when administered in isolation. In these trials MK-0752 was tolerated with acceptable side-effects when given to patients with cancer using a similar schedule as the current study.
The trial will initially test the safety of the drug at low levels, but the dose will be escalated as the trial proceeds to find a suitable dose level. Once a suitable dose has been defined, the second stage of the study is to test the effectiveness of the drug in treating pancreatic cancer.
The MK-0752 is being provided by pharmaceutical company Merck & Co Inc****, in a collaboration with Cancer Research UK’s Drug Development Office, to study it in patients with pancreatic cancer.
Every year around 7,800 people are diagnosed with pancreatic cancer in the UK – around 21 people every day. The one-year survival rate for the disease has more than doubled since the 1970s, but the rate is still very low with only around 16 per cent surviving beyond a year. In addition, only around three per cent of pancreatic cancer patients survive the disease for five years or more.
Professor Duncan Jodrell, chief investigator at Cancer Research UK’s Cambridge Research Institute, said: “We look forward to the results with interest because there are currently few treatment options for people with advanced pancreatic cancer. Unfortunately, the majority of patients with pancreatic cancer have advanced disease, by the time they develop symptoms and are diagnosed.”
MK-0752 works by blocking some of the enzymes needed for cell growth in a cell signalling pathway called Notch, which plays an important role in cell survival and cell movement. Blocking this pathway can result in the cell instructing itself to ‘self destruct.’.
Nigel Blackburn, director of drug development at Cancer Research UK’s Drug Development Office, said: “This trial is a promising step to find much-needed new treatments for pancreatic cancer so more lives can be saved.
“We are investing heavily into pancreatic cancer research in areas including the development of potential new vaccine treatments and searching for new ways to detect the disease early on so it can be treated as effectively as possible.”
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*A Cancer Research UK Phase I/IIa Trial of an Oral Notch Inhibitor (MK 0752) in Combination with Gemcitabine in Patients with Stage IV Pancreatic Cancer.
Dose-escalation will be guided by using a Bayesian adaptive design devised by Professor John Whitehead, Dr Thomas Jaki and Dr Helene Thygesen of the Medical and Pharmaceutical Statistics Research Unit at Lancaster University
MK-0752 inhibits the Notch signalling pathway, which may result in induction of growth arrest and apoptosis in tumour cells in which the Notch signalling pathway is over-activated. It inhibits an enzyme called gamma-secretase inhibitor. The Notch signalling pathway plays an important role in determining cell fate as well as cell growth and survival.
MK 0752 is manufactured by Merck & Co Inc.
Gemcitabine is a nucleoside analogue licensed for first line treatment of metastatic pancreatic cancer (and other solid tumours). It is marketed by Eli Lilly and Company as Gemzar.