A study of M6620 for cancer of the food pipe (oesophagus) and other solid tumours (CHARIOT)

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

Cancer type:

All cancer types

Oesophageal cancer

Status:

Closed

Phase:

Phase 1

This study is looking at M6620 with chemotherapy and, or radiotherapy for oesophageal cancer and other solid tumours.

A solid tumour is any cancer apart from blood cancers such as:

leukaemia
lymphoma
myeloma

Cancer Research UK supports this study.

More about this trial

M6620 is a targeted cancer drug. It works by blocking signals that tell damaged cancer cells to repair themselves.

We know from other studies that M6620 could help people with cancer.

Treatment for oesophageal cancer for people who can’t have or don’t want surgery is usually:

chemotherapy
radiotherapy
a combination of chemotherapy and radiotherapy (chemoradiation)

In this study the team want to find the best dose of M6620 to give with these treatments. They also want to find how often to give M6620.

Other aims of this study are to find out how well M6620 works and more about the side effects.

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part

There are 3 parts in this study.

To take part in any stage of the study

You may be able to join any part of the study if all of the following apply. You:

have satisfactory blood test results
can do everything apart from heavy physical work (performance status 0 or 1)
are willing to use reliable contraception during treatment and for 6 months after if there is any chance you or your partner could become pregnant
are at least 16 years old

To take part in stage A1

You may be able to join stage A1 of the study if all of the following apply. You:

have oesophageal cancer that is an adenocarcinoma or a squamous cell carcinoma
have cancer in the middle or lower part of the oesophagus
have cancer that is 10cm or less in length
are suitable to have radiotherapy to control symptoms (palliative radiotherapy) and aren’t suitable to have chemoradiation or surgery with the aim to cure your cancer

To take part in stage A2

You may be able to join stage A2 of the study if all of the following apply. You:

have any solid tumour that has spread to another part of the body or can’t be removed by surgery
can have cisplatin and capecitabine to treat your cancer

To take part in stage B

You may be able to join stage B of the study if all of the following apply. You:

have oesophageal cancer in the middle or lower part of the oesophagus that is an adenocarcinoma or a squamous cell carcinoma and is 7 cm or less in length or you have a gastro oesophageal junction cancer that is type 1 or type 2 and is 2cm or less in length
can have chemoradiation and aren’t suitable for surgery or choose not to have surgery
have tests that show your lungs and heart work well enough to have chemoradiation

Who can’t take part

You cannot join this study if any of these apply. You:

have cancer that has spread to the brain
have gastro oesophageal junction cancer that has a large amount of the HER2 protein where anti HER2 treatment is more suitable, unless you have had this treatment and it has failed (in this case you might be able to join stage A1 and A2)
have another cancer apart from carcinoma in situ of the cervix that has been removed by cone biopsy or successfully treated non melanoma of the skin
have had a serious heart problem such as a heart attack, congestive heart failure or unstable angina in the past 6 months
have problems with your heart beat such as irregular heart beat or very fast heart beat that needs treatment
have any other serious heart problem
have high blood pressure that is not controlled by medication
have an abnormal opening (fistula) between your breathing tube (trachea) and your food pipe (oesophagus)
have cancer that has grown from your food pipe into your breathing tube
have taken part in another clinical trial in the past month
have had medications that affect the CYP3A enzyme within 2 weeks of starting M6620
have had medication that helps your body to increase the number of blood cells (blood cell growth factors )
are taking warfarin and are unable to or unwilling to change to using heparin
have HIV, hepatitis B or hepatitis C
have any other medical or mental health condition that your doctor or the study team think could affect you taking part
are pregnant or breastfeeding

You can’t take part in stage A1

If any of the following apply. You:

have had radiotherapy to the chest or the upper part of the tummy (abdomen)
have a tube (a stent) in your food pipe to keep it open and stop it from blocking

You can’t take part in stage A2

If any of the following apply. You:

have had hand and foot syndrome
have problems with your hearing
have had a live vaccine within 30 days of starting M6620

You can’t take part in stage B

If any of the following apply. You:

have already had chemotherapy
have a tube (a stent) in your food pipe to keep it open and stop it from blocking
have had hand and foot syndrome
have problems with your hearing
have had a live vaccine within 30 days of starting M6620

Trial design

This is a phase 1 study. There are 3 stages to the study. Everyone will have M6620.

The study team want to find the best dose, and how often, to give M6620 with:

radiotherapy (stage A1)
cisplatin and capecitabine (stage A2)
chemoradiation (stage B)

The dose and how often you have M6620 will vary depending on when you agree to join the study. But the dose of M6620 and how often you have M6620 will stay the same while you are taking part of the study.

Stage A1

In stage A1 the team need up to 20 people to join.

You have radiotherapy once a day, Monday to Friday, for 3 weeks. You have M6620 an hour after having radiotherapy.

You have M6620 as a drip into a vein. You have it over 1 hour to 1½ hours. Your doctor will tell you how often you are to have M6620. This will be either once or twice a week.

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Stage A2

In stage A2 the team need up to 20 people to join.

You have cisplatin as a drip into a vein. You have it over 2 hours. You have it once every 3 weeks. Each 3 week period is called a cycle of treatment. You have up to 6 cycles of cisplatin.

Capecitabine is a tablet. You take it twice a day during the cycles of cisplatin treatment. You take capecitabine within 30 minutes after eating. Your doctor will tell you how many tablets you must take.

You have M6620 once or twice each week. You have M6620 as a drip into a vein. It takes between 1 and 1½ hours. Your doctor will tell you how often you are to have M6620. This will be either once or twice a week.

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Stage B

In stage B the team need up to 25 people to join.

You have treatment with cisplatin and M6620 every 3 weeks. Each 3 week period is called a cycle of treatment.

Before starting radiotherapy, you have 2 cycles of treatment with cisplatin and M6620. You have cisplatin at the start of each cycle.

You have M6620 the day after you have cisplatin (2nd day of the treatment cycle). How often you have M6620 will depend on when you agree to join the study.

You take capecitabine twice a day every day during the first 2 cycles of treatment of cisplatin. You take capecitabine within 30 minutes after eating. Your doctor will tell you how many tablets you must take.

You have radiotherapy Monday to Friday for 5 weeks. During radiotherapy you have cisplatin at the start of each 3 week period of treatment (a cycle of treatment).

You have M6220 an hour after radiotherapy on the 2nd day of each cycle. This may be more regular depending on when you join the study.

When you start radiotherapy, you take capecitabine twice a day on the days you have radiotherapy, Monday to Friday. You don’t take capecitabine on Saturday or Sunday.

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You have a diary card to record when you have your capecitabine. You must bring this to every hospital visit for the doctor to see.

Blood and tissue samples
People in stage A2 and stage B will have extra blood samples taken.

The study team will use these blood samples to understand how M6620 affects your body and the cancer cells.

People in stage B will also have 2 extra samples of tissue taken from their cancer. The team will use these to find out how M6620 affects the cancer cells.

When you agree to join stage A2 or stage B you must also agree to have these blood and tissue samples taken.

Hospital visits

You see the doctor to have some tests before taking part in the study. These tests include:

a physical examination
blood tests
heart trace (ECG )
CT scan

People in stage A2 and stage B may also have a hearing test, if needed.

During treatment you see the doctor regularly to see how you are.

If you are in stage A2 you have a CT scan every 6 weeks during treatment.

Stage A1

You see the doctor after treatment at:

1 week
6 weeks
9 weeks

You have:

a physical examination
blood tests
heart trace at week 4 and week 12
CT scan at week 12

Stage A2

You see the doctor 2 weeks and 8 weeks after treatment for a physical examination and blood tests.

You have a CT scan 8 weeks after treatment.

Stage B

You see the doctor 1 week after finishing treatment then at 7 weeks and 13 weeks. You have a physical examination and blood tests. You have a CT scan and heart trace at 12 weeks. Another sample of cancer tissue (biopsy) is taken at 12 weeks.