A trial looking at crizotinib, PD-0325901 and binimetinib (MErCuRIC1)

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 drugs called crizotinib (also known as PF-02341066), PD-0325901 and binimetinib (also known as MEK162).

More about this trial

There are 2 parts to this trial. The 1st part is for people with any type of cancer apart from leukaemia Open a glossary item or lymphoma . In this part, researchers initially looked for the highest safe doses of crizotinib and PD-0325901 or binimetinib that you can have together. They are now looking at the highest safe doses of crizotinib and binimetinib you can have together.

The 2nd part is for people who have bowel cancer with changes to certain proteins that affect how the cancer behaves. The trial team will test a sample of your cancer to check this.

Doctors can treat bowel cancer with

Crizotinib, PD-0325901 and binimetinib are biological therapies called cancer growth blockers. They stop signals that tell cancer cells to divide and grow.

We know from laboratory studies Open a glossary item that the combination of crizotinib with PD-0325901 or binimetinib might be better than either of them alone. Researchers want to find out how well having crizotinib with PD-0325901 or binimetinib together works in people with bowel cancer.

In the 2nd part of the trial, the researchers will use the highest safe doses of crizotinib and binimetinb that they found in the 1st part.

The main aims of this trial are to:

find the highest safe doses of crizotinib and PD-0325901 that you can have together
find the highest safe doses of crizotinib and binimetinib that you can have together
see how well the drug combination crizotinib and binimetinib works for people with bowel cancer whose cancer cells have changes to certain proteins
find out what happens to crizotinib and PD-0325901 or binimetinib in the body
learn more about the side effects of having crizotinib and PD-0325901 or binimetinib together
look for substances called biomarkers that may show how well this treatment is working

Who can enter

This trial has 2 parts.

You may be able to join the 1st part if you have a solid tumour Open a glossary item that has spread to another part of your body.

You may be able to join the 2nd part if:

you have a type of bowel cancer called an adenocarcinoma
you are not able to have surgery with the aim of curing your cancer
the cells of your cancer have changes to certain proteins (the trial team will test a sample of your cancer to check for these)
your cancer got worse during, or within 6 months of finishing treatment after surgery to try to stop your cancer coming back (adjuvant treatment ), or after having chemotherapy or biological therapy for cancer that has spread to another part of your body
a sample of tissue (biopsy ) can be taken from where your cancer has spread
you have another area of cancer spread that can be measured on a scan

For both parts of the trial all of the following must apply:

your heart and lungs work well enough (your doctor will test these)
you have satisfactory blood tests results
you are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
you are able to swallow tablet or capsules
you are willing to use reliable contraception for a month before starting treatment, during treatment, and for 6 months afterwards if there is any chance you or your partner could become pregnant
you are at least 16 years old

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

have cancer that has spread to your brain or spinal cord unless it has been treated with radiotherapy or surgery and has not got any worse for at least 3 months
have an area of cancer pressing against your spinal cord (spinal cord compression) unless this has been treated, isn’t causing you pain and you don’t have symptoms, or if you do, they aren’t getting worse
have had cancer treatment in the last 4 weeks apart from radiotherapy for symptom control or some types of hormone treatment for prostate cancer
have had surgery in the last 3 weeks
have had drugs called nitrosoureas or a drug called mitomycin C in the last 6 weeks
have had treatment as part of another clinical trial in the last 4 weeks
take other medication that affects body substances called CYP enzymes (your doctor can advise you about this)
have had another cancer in the last 3 years apart from non melanoma skin cancer, carcinoma in situ of the cervix or any other cancer that has been successfully treated
have certain heart problems, eye problems, lung problems or problems with your digestive system (the trial team can advise you about this)
have an infection
have HIV, hepatitis B or hepatitis C
have any other medical condition or mental health problem that the trial team thinks could affect you taking part in the trial
are pregnant or breastfeeding

Trial design

This is a phase 1 trial. The trial team need between 92 and 148 people to join.

Everyone who joined the trial before August 2016 had crizotinib and PD-0325901. Everyone who agrees to join the trial after August 2016 will have crizotinib and binimetinib.

PD-0325901 is a tablet you take twice a day. To begin with you take it for 4 weeks. After this you take it for 3 weeks and then have a week of not taking it.

As PD-0325901 can make your skin more sensitive to sunlight you should avoid being in the sun for too long and use sunscreen if you are going outside.

Crizotinib is a tablet you take once or twice a day every day. You start taking it at the beginning of the 2nd week of taking PD-0325901.

After August 2016

Binimetinib is a tablet you take twice a day. Your doctor will tell you how you take it. This might be every day for 3 weeks and then a week of not taking it.

You start taking crizotinib as above at the same time you start binimetinib.

This trial is in 2 parts. In the 1st part, the first few people will have low doses of both crizotinib and binimetinib. If they don’t have any serious side effects, the next few people will have higher doses. And so on, until they find the best doses to give. This is called a dose escalation study.

In the 2nd part your doctor will tell you how many tablets of crizotinib and binimetinib to take.

Whichever part of the trial you join, you continue having treatment as long as it is helping you and the side effects aren’t too bad.

The trial team will give you a diary card that tells you when you need to take your tablets.

Skin and tissue samples

As part of this trial, the researchers will ask for a small sample of your skin (biopsy Open a glossary item ). It is quick, and usually leaves only a very small wound. You have a dressing on the wound afterwards. You have 2 biopsies before starting treatment and you must agree to these to take part. They will also want to take more biopsies during and after treatment, but you don’t have to agree to these if you don’t want to. They will use the samples to find out how the treatment affects your skin.

The team will ask for a sample of your cancer that was removed when you had surgery or a biopsy and for some extra blood samples. They will use these to look for substances (biomarkers Open a glossary item ) that may be used to find out how well the treatment works and to find out more about your cancer.

Hospital visits

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

A physical examination
Blood tests
Eye tests
CT scan or MRI scan
Heart trace (ECG )
Heart scan (ECHO )

The team will ask for a sample of your cancer that was removed when you had surgery or a biopsy Open a glossary item and for some extra blood samples. They will use these to look for substances (biomarkers ) that may be used to find out how well the treatment works and to find out more about your cancer.

During treatment you see the doctor at least once a week for blood tests and a physical examination. You have:

an eye test after 4 weeks of treatment and then every 8 weeks
a heart trace every 4 weeks
a CT scan or MRI scan after 8 weeks
a heart scan

A month after finishing treatment you see the doctor and have most of the same tests you had at the beginning. You then see the trial team every 3 months.