"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at gemcitabine with MK-0752 to treat pancreatic cancer
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at giving MK-0752 with gemcitabine to treat pancreatic cancer. This trial is supported by Cancer Research UK.
The researchers think that combining MK-0752 with gemcitabine may be better than gemcitabine alone.
The aims of this trial are to find out
- The highest, and safest, dose of MK-0752 and gemcitabine that you can have together
- The side effects of MK-0752 and gemcitabine
- How to manage these side effects
- What happens to MK-0752 in the body
- What effect the combination of MK-0752 and gemcitabine has on pancreatic cancer
Who can enter
You can enter this trial if you
- Have the most common type of pancreatic cancer (adenocarcinoma) that has grown outside the pancreas into the nearby large blood vessels (stage 3) or has spread to another part of your body (stage 4)
- Have a tumour that can be measured on a CT scan, MRI scan or X-ray
- Can have a small piece of tissue (
biopsy) taken from your tumour (if the researchers need it) - your doctor can advise about this
- Have satisfactory blood test results
- Are willing to use reliable contraception if there is a chance that you or your partner could become pregnant
- Are at least 18 years old
You cannot enter this trial if
- Your cancer has spread to the brain (unless your symptoms have not changed in the last 4 weeks and you have been taking the same dose of steroids for a while – your doctor can advise about this
- You have had hormone therapy, immunotherapy or radiotherapy (you may join the trial if the radiotherapy was only to control symptoms)
- You are still having side effects from previous treatments – your doctor can advise about this
- You are taking a drug as a part of another clinical trial
- You have had major surgery to the chest or tummy (abdomen) and are not better
- You are taking a drug called warfarin to stop blood clots (unless you are able to change to a similar drug called heparin – your doctor can advise about this)
- You are known to be HIV, hepatitis B or hepatitis C positive
- You have a major heart problem or a history of decreased blood supply to the heart or irregular heart beats
- You have another cancer, unless it has been treated and there has been no sign of it (
complete remission) for at least 5 years (you may join the trial if you have in situ carcinoma of the cervix and basal cell or squamous cell skin cancer)
- You have another medical condition that could affect you taking part in this trial
This is a phase 1 trial. It will recruit about 56 people in the UK. Everyone will have MK-0752 and gemcitabine.
The first 2 patients taking part will have the lowest dose of MK-0752. If they don’t have any serious side effects, the next 2 patients will have a higher dose. And so on, until they find the best dose to give. This is called a ‘dose escalation study’.
At each dose of MK-0752, the researchers will use 2 doses of gemcitabine. One dose will be slightly lower than the other.
MK-0752 is a capsule. You take it once a week. To start with, you have 2 weeks of taking MK-0752 only. Then you start having it with gemcitabine.
You have gemcitabine once a week for 3 weeks and 1 week of no gemcitabine. You have gemcitabine through a drip into a vein (intravenous) over 30 minutes.
Each 4 week period is called a cycle of treatment.
You can have up to 12 cycles of treatment as long as it is helping you and you have no serious side effects.
Before you start treatment and at the 2nd dose of MK-0752, the researchers will take a small piece of tumour tissue sample (biopsy), if you are one of the people who need to give one. The researchers will also take a few hairs from your head when you start taking MK-0752. This is to see how MK-0752 is working in your body.
You will see the doctor and have some tests before taking part in this trial. These tests include
- Physical examination
- Blood tests
- Urine test
- Heart trace (
- CT scan
- Pregnancy test (if appropriate)
During treatment you see the doctor every week to have
- Physical examination
- Blood tests
- Urine test
- CT scan (every 8 weeks)
After taking MK-0752 for 2 weeks, you may have a biopsy.
MK-0752 and gemcitabine have many side effects in common including
- Loss of appetite
- Feeling, or being, sick
- Tummy pain (abdominal pain)
- Skin rash
- Liver changes
Other side effects of gemcitabine can include
- A drop in blood cells causing an increased risk of infection, bruising and bleeding problems
- Hair loss
- Kidney changes
- Swelling in your hands, feet or legs
- Flu like symptoms
- Sore mouth or mouth ulcers
But this is the first time MK-0752 and gemcitabine have been given in combination and there may be side effects we do not know about.
We have more information about gemcitabine.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Prof Duncan Jodrell
Cancer Research UK (Centre for Drug Development)
Experimental Cancer Medicine Centre (ECMC)
Merck & Co. Inc
NIHR Clinical Research Network: Cancer