A trial of vandetanib and selumetinib for solid tumours including non small cell lung cancer (VanSel-1)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

All cancer types

Status:

Closed

Phase:

Phase 1

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 solid tumour Open a glossary item is any cancer apart from leukaemia or lymphoma.

This trial is supported by Cancer Research UK.

More about this trial

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 inhibitor Open a glossary item . 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

See if it is safe to have vandetanib and selumetinib together
Find the highest dose of selumetinib that you can safely have at the same time as vandetanib
Learn more about the side effects and what happens to the drugs in your body

Who can enter

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

Chemotherapy that might have included a platinum drug
Treatment with the drugs erlotinib (Tarceva) or gefitinib (Iressa) or any other type of EGFR inhibitor

And as well as the above, for either part of the trial

There is no standard treatment available for you, or you do not want to have the standard treatment for some reason
You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
You have satisfactory blood test results
You are over 18 years of age
You are willing to use reliable contraception during the trial and for 6 months afterwards if there is any chance you or your partner could become pregnant (women who could possibly become pregnant must also use reliable contraception for 4 weeks before joining the trial)

You cannot enter this trial if you

Have cancer that has spread to your brain and is causing symptoms – you may take part if you had radiotherapy for cancer spread to the brain at least 3 months ago, it has not got worse since and is not causing symptoms
Have cancer that is pressing on your spinal cord (spinal cord compression)
Have had radiotherapy (apart from radiotherapy for symptoms) in the last 4 weeks
Have had hormone therapy, immunotherapy or chemotherapy in the last 4 weeks
Are taking part in any other trial looking at an experimental drug, or have had another experimental drug in the last 6 weeks
Have already had a drug that targets EGFR and you had to stop taking it because of bad side effects
Have already had drugs that target MEK or VEGFR
Have not recovered from surgery
Have not recovered from the side effects of other treatment (apart from hair loss) unless they are very mild – the trial doctors can advise you about this
Have a type of lung disease called interstitial lung disease
Have had a heart attack in the last 3 months or have any other heart condition that is a cause for concern – the trial doctors can advise you about this
Have or have had certain problems with your eyes such as retinal pigment epithelial detachment (RPED), central serous retinopathy (CSR) or retinal vein occlusion
Have high pressures in your eyes (intraocular pressure) or glaucoma that is not controlled by treatment
Have an infection that cannot be controlled with medication or any other medical condition that the trial doctors think could affect you taking par
Have had any other type of cancer in the last 5 years apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated
Cannot swallow or absorb tablets or capsules for some reason
Take other medication that can affect an enzyme called CYP3A4 – your doctor can advise you about this
Are known to be HIV, hepatitis B or hepatitis C positive
Are pregnant or breastfeeding

Trial design

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 biopsy Open a glossary item . 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.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

Physical examination including an eye test
Blood and urine tests
Heart trace (ECG )
Heart ultrasound (echocardiogram ) or MUGA scan
Chest X-ray

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.

Side effects

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