“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A trial of NUC-1031 for advanced solid tumours
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a drug called NUC-1031 for solid tumours that have spread. A
Doctors use a chemotherapy drug called gemcitabine to treat different types of cancer. But sometimes cancer stops responding to gemcitabine (it becomes
NUC-1031 is very similar to gemcitabine, but it has been changed so that the drug is released directly into cancer cells. This may overcome resistance, but this is the first time NUC-1301has been tested in people.
The aims of the trial are to
- Find the highest dose of NUC-1031 you can safely have and the best way to have it
- Learn more about the side effects and what happens to the drug in your body
- See if NUC-1031 helps people with advanced solid tumours
Who can enter
You may be able to join the trial if all of these apply.
- You have a cancer other than leukaemia or lymphoma (a
- Your cancer is not responding to other treatment or there is no
- You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- You are at least 18 years old
- You have cancer that can be measured either on a scan or by measuring certain markers in your blood
- You have satisfactory blood test results
- You are willing to use reliable contraception during the trial and for 3 months afterwards if there is any chance you or your partner could become pregnant
You cannot enter this trial if you
- Have cancer that has spread to your brain
- Have had an allergic reaction to gemcitabine
- Have had radiotherapy in the last 4 weeks unless it was to just 1 area of your body to control bone pain
- Have had
immunotherapyor chemotherapyin the last 4 weeks (in the last 6 weeks if you had a drug called mitomycin C or a drug called a nitrosourea)
- Have had hormone therapy or biological therapy in the last 2 weeks
- Have not fully recovered from the side effects of other treatment unless they are very mild (apart from hair loss or nerve damage)
- Have another illness that cannot be controlled with medication or an infection that needs treatment with antibiotics into a vein
- Have any other medical condition or mental health problem that the trial team think could affect you taking part
- Are known to be HIV, hepatitis B or hepatitis C positive
- Are pregnant or breastfeeding
As well as the above, you can't enter the 2nd part of the trial if you have any other type of cancer apart from basal cell skin cancer, carcinoma in situ of the cervix or melanoma that is only in the outer layer of your skin (melanoma in situ).
This phase 1 trial will recruit up to 95 people in total. Everybody taking part will have NUC-1031.
You have NUC-1031 as an injection into a vein in 3 out of every 4 weeks. It takes between 10 and 30 minutes each time. As the researchers are trying to find the best way to give the drug, some people taking part have injections once a week, some have them twice a week.
Each 4 week period is called a cycle of treatment. As long as you don’t have bad side effects, you have up to 6 cycles of treatment. If NUC-1031 seems to be helping you, the trial team may talk to you about having it for longer.
The trial is in 2 parts. In the first part, the researchers want to find the highest dose of NUC-1031 you can safely have. The first few patients will have a low dose. If they don’t have any serious side effects, the next patients will have a higher dose. And so on, until they find the best dose to give. This is called a dose escalation study.
In the second part of the trial, researchers want to learn more about the safety of NUC-1031 and the effect it has on certain cancers. Everybody will have the highest safe dose that was found in part 1. And everybody will have the injections in the same way – either once a week or twice a week, depending on the results of part 1.
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- Heart trace (
- CT scan
You may have an extra scan called a PET-CT scan.
The trial team will ask for a sample of the tissue that was removed when you had surgery to remove your cancer or a
You go to hospital once or twice a week during treatment, depending on how often you have the injections. You have regular blood tests and a CT scan every 2 months. When you finish treatment, you see the trial team again about 4 weeks later.
As this is the first time NUC-1031 has been tested in people, there may be side effects we don’t know about yet. But as it is very similar to gemcitabine, the researchers expect the side effects to be similar. These include
- Feeling or being sick
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- High temperature (fever)
- Change to the way your liver and kidneys work
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.
Dr Sarah Blagden
Experimental Cancer Medicine Centre (ECMC)
Imperial College London