
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at 2 new drugs called vandetanib and selumetinib for people who have solid tumours including non small cell lung cancer. A is any cancer apart from leukaemia or lymphoma.
This trial is supported by Cancer Research UK.
Vandetanib is a type of biological therapy called a tyrosine kinase inhibitor (TKI). Tyrosine kinases are proteins that cells use to signal to each other to grow. TKIs block tyrosine kinases which can stop cancer cells growing.
Selumetinib is another type of biological therapy called a . MEK is another body protein that sends signals to cells telling them to divide and grow. Blocking MEK may also stop cancer cells growing.
Researchers think that having both drugs together may be better than having either of them alone.
Most people who have taken part in earlier trials of vandetanib had non small cell lung cancer. In this trial, a small number of people with other types of cancer can also take part. Everybody will have vandetanib and selumetinib.
The aims of the trial are to
You may be able to enter the 1st part of this trial if you have any solid tumour (a solid tumour is any cancer apart from leukaemia or lymphoma).
For the 2nd part of the trial you must have non small cell lung cancer. You must have also had at least 1 of the following
And as well as the above, for either part of the trial
You cannot enter this trial if you
This phase 1 trial is in 2 parts.
Part 1 will recruit between 9 and 45 people who have solid tumours. The first few people taking part have vandetanib with a low dose of selumetinib. If they don’t have any serious side effects, the next patients will have a higher dose of selumetinib. And so on, until they find the best dose to give. This is called a dose escalation study.
Part 2 will recruit about 30 people who have non small cell lung cancer. They will all have vandetanib and the highest safe dose of selumetinib found in part 1. In this part of the study, the researchers want to learn more about the side effects and whether having these 2 drugs together helps people with non small cell lung cancer.
In both parts of the trial you take vandetanib tablets once a day for 14 days. Then you start taking selumetinib capsules each day as well. You take them in the morning and in the evening. You cannot eat anything for 2 hours before you take selumetinib, or for an hour afterwards – you can drink water.
As long as you don’t have bad side effects, you can carry on taking both drugs every day for as long as the treatment helps you.
If you join the 2nd part of the trial, the trial team will need to get a sample of your cancer that was removed when you had surgery or a . If there is not a sample available, you will have to have another biopsy during a bronchoscopy. The researchers will use the sample to look for specific proteins to see if they affect the way the treatment works.
The trial team will also ask you to take part in some other studies. They may ask you to have 3 extra biopsies. They take these during a bronchoscopy before you start treatment, 1 or 2 weeks later and then a month later. They will use these samples to look for substances called biomarkers that can help doctors to measure how well a treatment is working.
Or they may ask you to have some extra scans called FDG PET-CT scans and dynamic contrast enhanced MRI scans (DCE MRI scans). The researchers want to learn more about the activity of the drugs in your body and the effect they have on blood vessels.
Whether they ask you to have extra biopsies or extra scans will depend on when you join the trial. You have to chose one of these options if you wish to take part in the main trial.
You will see the doctors and have some tests before you start treatment. The tests include
You will have a CT scan or MRI scan if you have not had one in the last 4 weeks, and you may need to have a bone scan.
You have about 12 hospital visits in the first 2 months of treatment. At these visits, you have a number of blood tests and ECGs.
After the first 2 months, you then see the trial team once every 4 weeks while you are having the trial treatment. You have a blood test at each visit. You have an ECHO or MUGA scan every 3 months, but you may have extra heart scans or eye tests if your doctor thinks you need them. You have a CT or MRI scan every 8 weeks.
When you finish the treatment, you see the trial team and have a scan about 4 weeks later. If you are still having side effects from the drugs, the trial team will continue to see you until these get better. A year after you finish treatment, the trial team will ask your doctor to let them know how you are.
As vandetanib and selumetinib are new drugs, there may be some side effects we don’t know about yet. And it is possible that side effects may be different or worse when you take both drugs at the same time.
The most common side effects of vandetanib include
The most common side effects of selumetinib include
Before you agree to take part, the trial team will give you more information about all the other possible side effects of both drugs.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Denis Talbot
AstraZeneca
Cancer Research UK (Centre for Drug Development)
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
This is Cancer Research UK trial number CRUKD/11/001.
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”