A trial of a new drug called XL184 for medullary thyroid cancer

Please note this trial is no longer recruiting patients.

This trial is looking at a new drug called XL184 for medullary thyroid cancer that has spread outside the thyroid gland and cannot be removed with surgery.

Doctors may use chemotherapy for medullary thyroid cancer that has spread. But this treatment does not always work very well and researchers are looking for new drugs to treat people in this situation.

XL184 is a cancer growth blocker. It works by blocking growth factors and proteins that tell cancer cells to divide, and by stopping tumours growing their own blood vessels.

Researchers want to see if XL184 slows down the growth of medullary thyroid cancer. In this trial, they are comparing it with a dummy drug (placebo). The aims of the trial are to

See how well XL184 works for medullary thyroid cancer
Find out more about what happens to the drug in the body
Learn more about the side effects of XL184

Recruitment

Start 01/05/2009

End 31/01/2011

Phase

Phase 3

Who can enter

You can enter this trial if you

Have been diagnosed with medullary thyroid cancer that has spread outside the thyroid gland and cannot be removed with surgery
Have cancer that appears to be getting worse on scans or X-rays
Are well enough to take part in the trial (performance status 0, 1 or 2)
Have recovered from any side effects from earlier cancer treatment, unless they are very mild
Have satisfactory blood test results
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
Are at least 18 years old

You cannot enter this trial if you

Have cancer that has spread to your brain or spinal cord unless it was treated with radiotherapy at least 4 weeks ago, is no longer causing symptoms and you have not had to take steroids or medicine to stop fits for at least 10 days
Have had radiotherapy to more than a quarter of your bone marrow (your doctor will be able to advise you about this)
Have had biological therapy or chemotherapy in the last 4 weeks (6 weeks if you had one of a group of drugs called nitrosoureas or a drug called mitomycin C)
Have had any other experimental drug as part of another clinical trial in the last 4 weeks
Have already had treatment with XL184
Are known to be sensitive to any of the ingredients of XL184
Have another cancer, apart from non melanoma skin cancer or carcinoma in situ of the cervix, or any other cancer that was diagnosed at least 2 years ago and you have no signs of the disease now
Have vomited blood or recently coughed up more than half a teaspoon of blood
Have had a stroke or heart attack in the last 6 months
Have heart failure or have had unstable angina in the last 3 months
Have any other serious medical condition such as high blood pressure that cannot be controlled with medication, or an infection that is currently being treated
Are pregnant or breastfeeding

Trial design

This is an international trial. It will recruit abut 315 people in different countries. It is a randomised trial. The people taking part are put into different study treatment groups by a computer. Neither you nor your doctor can decide which group you are in. And you will not know which group you are in either. This is called a double blind trial.

You have XL184 or the dummy drug as capsules. You take them at home each day with a glass of water. You must not eat anything for at least 1 hour before and 2 hours after taking the capsules. You can continue to have the study treatment as long as there are no signs of your cancer getting worse and you are not having bad side effects.

Before you start study treatment, the trial team will ask you to fill in a questionnaire asking about any symptoms you have and how bad they are. They will ask you to fill out the same questionnaire every 3 months during study treatment to see if you think any of your symptoms are better or worse.

The doctors will get a small sample of the tissue that was removed when you had surgery to remove your tumour or a biopsy. They will also take a number of blood samples before, during and after study treatment.

If there is not a tissue sample available, they will ask you to have a biopsy before you start study treatment. The researchers will look at the DNA in the tissue sample and in your blood. This is to see if anything in your genes can help them to understand more about medullary thyroid cancer, and how people respond to study treatment.

The researchers are also trying to find biomarkers. These are substances in the body that doctors can measure to help them see how a treatment is working. They want to learn more about what happens to XL184 in the body, this is called pharmacokinetics.

Any samples will only be used for research into cancer. After the end of the study, the samples may be stored for up to 15 years.

Hospital visits

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

Physical examination
Heart trace (ECG)
Blood tests
Urine test
Pregnancy test (if you are a woman and could possibly become pregnant)
MRI scan or CT scan
Bone scan

You visit the hospital and have blood tests every 2 weeks during the first 8 weeks of study treatment and every 4 weeks after that. At some of the hospital visits, you will have a number of blood tests and ECGs before and after you take the capsules. You will be at hospital for quite a few hours on these days. You have a scan every 3 months during study treatment.

After you finish study treatment, you will go back to see the trial doctors about a month later. From then on, a member of the trial team will phone you every 3 months to see how you are.

If you stop the study treatment for any reason other than your cancer getting worse, or you choosing not to continue with the trial, you will be asked to carry on having scans and blood tests, and filling out the symptom questionnaire every 3 months until your cancer starts growing again.