A trial of a drug called NUC-1031 for advanced solid tumours
Cancer type:
All cancer types
Status:
Results
Phase:
Phase 1
This trial looked at a new drug called NUC-1031. It was for people with a solid tumour that had spread to other parts of the body (advanced cancer). And who had completed all their 
.
A solid tumour is any type of cancer apart from or .
More about this trial
This trial started in 2012 and these results were reviewed in 2018.
Gemcitabine is a common chemotherapy drug. At the time this trial was done, gemcitabine was used as a treatment for many different types of advanced cancer. But many cancers are resistant to it, or they become resistant to it after some time. This means that the treatment has no effect, or stops working.
NUC-1031 was designed to be a more effective and safer version of gemcitabine. This trial was the 1st time that NUC-1031 was given to people.
The researchers wanted to:
- find the highest dose of NUC-1031 that you can safely have
- learn about the side effects
- see whether NUC-1031 helps people with advanced solid tumours
Summary of results
The trial team concluded that NUC-1031 helps people with solid tumours that have spread to other parts of the body (advanced solid tumours).
68 people took part in this phase 1 trial. Everyone had NUC-1031 as an injection into a vein once a week, for 3 weeks. They then had a break of a week. They continued to have NUC-1031 for 3 weeks out of every 4 weeks for as long as the treatment was helping them.
This trial was in 2 parts. In the 1st part, people had different doses of NUC-1031. The first few people had a low dose of NUC-1031. As they didn’t have bad side effects, the next few people had a higher dose. And so on, until the research team found the best dose to give. A total of 47 people joined this part of the trial.
In the 2nd part, everyone had the highest safe dose found during part one. A total of 21 people joined this part of the trial.
Results
Doctors were able to find the highest safe dose of NUC-1031 during the 1st part of the trial. They then gave that dose to everyone that joined the 2nd part.
The trial team looked at how well NUC-1031 worked. To do this, they looked at the results of 49 people. Doctors found that:
- in 5 out of the 49 people, the cancer shrunk by at least a third (partial response). This is around 1 in every 10 people who took part (10%)
- in 33 out of the 49 people, the cancer stayed the same, or shrunk by less than 30% (stable disease). This is almost 7 in every 10 people who took part (70%)
- in 11 out of the 49 people, their cancer grew (progressive disease)
- in 10 out of the 16 people who had cancer that had previously not responded to gemcitabine, the cancer shrank or stayed the same
Side effects
Doctors looked at the moderate and serious side effects that people had. Side effects included:
- a drop in the number of blood cells causing an increased risk of breathlessness, infections and bleeding
- an increase in the amount of liver enzymes
Conclusion
The trial team concluded that NUC-1031 helps people with advanced solid tumours. They think it is a safe treatment.
Doctors are now looking at how well NUC-1031 works alone and together with other anti cancer drugs for people with pancreatic cancer, ovarian cancer or cancer of the bile duct.
We have based this summary on information from the research team. As far as we are aware, the information they sent us has not been reviewed independently (peer reviewed ) or published in a medical journal yet. The figures we quote above were provided by the research team. We have not analysed the data ourselves.
) or published in a medical journal yet. The figures we quote above were provided by the research team. We have not analysed the data ourselves.Recruitment start:
Recruitment end:
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.
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
Chief Investigator
Dr Sarah Blagden
Supported by
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Imperial College London
National Institute for Health Research (NIHR)
NuCana Biomed Ltd
Oxford Cancer Research Centre
Oxford University Hospitals NHS Trust
University of Oxford
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last review date
CRUK internal database number:
10708
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
