A study looking at tasquinimod for advanced cancer of the liver, ovary, kidney and stomach

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

Cancer type:

Kidney cancer

Liver cancer

Ovarian cancer

Renal cell cancer

Stomach cancer

Status:

Closed

Phase:

Phase 2

This study is looking at tasquinimod for liver cancer, ovarian cancer, kidney cancer and stomach (gastric) cancer. The study is for people whose cancer has come back or spread to another part of the body. This is called advanced cancer.

Doctors can use chemotherapy, surgery and biological therapies to treat advanced cancer of the ovaries, kidney and stomach. They also use a biological therapy called sorafenib to treat advanced liver cancer. But sometimes these cancers can continue to grow or come back after having these standard treatments Open a glossary item . Researchers are always looking for new drugs to help people in this situation. In this study they are looking at tasquinimod.

Tasquinimod is a type of biological therapy. It works by blocking the growth of new blood vessels to the cancer and by helping the body’s immune system.

The aim of this study is to find how well tasquinimod works for people with advanced cancer of the liver, ovary, kidney and stomach.

Who can enter

You may be able to enter this study if you are in one of the following situations.

You have a type of liver cancer called hepatocellular carcinoma (HCC) and

Your cancer has spread into the blood vessels, lymph nodes or to another part of your body (stage C), or you have many tumours in your liver (stage B)
You can’t have treatment that affects only the area of cancer, such as radiofrequency ablation or surgery to remove the cancer (or your cancer came back after such treatment)
Your liver is working well
You have an area of cancer that is at least 2 cm in size that can be seen on a CT or MRI scan
You have had sorafenib as your most recent treatment

You have a type of ovarian cancer called epithelial ovarian cancer or cancer of the fallopian tube or primary peritoneal cancer and

Your cancer came back or started to grow again within 6 months of having a platinum chemotherapy drug such as cisplatin or carboplatin, or your cancer came back or started to grow again after having 3 different types of chemotherapy treatment
You haven’t had more than 1 type of treatment that aims to block the growth of blood vessels (anti angiogenic treatment)

You have a type of kidney cancer called renal cell cancer and

The cancer contains some clear cell cancer cells
The cancer has spread to another part of your body and has come back or started to grow again in the last 6 months
You have had no more than 2 different types of treatment for advanced kidney cancer that targets specific proteins in cancer cells for example sunitinib and sorafenib
You have had treatment with at least 1 drug that targets VEGF – your doctor can confirm this

You have a type of cancer called adenocarcinoma Open a glossary item that started in your stomach or where your food pipe joins your stomach (gastro oesophageal junction) and

Your cancer has spread to another part of your body, or can’t be removed with surgery, or has come back after surgery that aimed to cure it
Your cancer has got worse after treatment with a fluoropyrimidine chemotherapy drug, such as 5FU or capecitabine, and a chemotherapy drug from the group called platinum drugs – your doctor can confirm this
You haven’t had more than 1 type of treatment that aims to block the growth of blood vessels (anti angiogenic treatment)

You must also

Be well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
Have an area of cancer that can be measured on a scan
Have satisfactory blood test results
Be able to swallow capsules
Be willing to use reliable contraception during treatment and for 3 months afterwards if there is any chance you or your partner could become pregnant
Be at least 18 years old

You cannot enter this study if

You have a type of liver cancer called fibrolamellar carcinoma
You have had hormone therapy in the last week – your doctor can confirm this
You have had chemotherapy, monoclonal antibodies, immunotherapy or radiotherapy in the last 4 weeks – your doctor can confirm this
Your cancer has spread to your brain or spine and this is causing symptoms or needs treatment
You have had another cancer in the last 3 years apart from non melanoma skin cancer that has been removed with surgery, early prostate cancer with a normal PSA blood test or in situ carcinoma of the cervix
You have ever had inflammation of your pancreas (pancreatitis)
You have a problem with your digestive system (apart from having stomach cancer or surgery to remove part or all of your stomach) that means you can’t absorb capsules
You are taking medication that affects body proteins called cytochrome P enzyme – your doctor can confirm this
You have had a heart attack or unstable heart pain (angina) in the last 6 months or you have any other serious heart problem
You have high blood pressure that isn’t controlled
You have a problem with bleeding or clotting of your blood
You have had a blood clot in the last 3 months
You are HIV positive
You have any other condition that could affect you taking part in this trial
You are allergic to tasquinimod , or any of its ingredients
You are pregnant or breastfeeding

Trial design

This is a phase 2 study. It will recruit 200 people. There are 4 groups

50 people with liver cancer
50 people with stomach cancer
50 people with kidney cancer
50 people with ovarian cancer – This group is now full and has stopped recruiting people.

Tasquinimod is a capsule. You take it once a day at the same time each day. You take it with your evening meal and a glass of water. You have a diary to record when you take it.

You start by taking a small dose for 2 weeks. If you have no bad side effects, your dose is then increased. You continue having tasquinimod as long as it is helping and the side effects aren’t too bad.

The researchers will take some blood samples. They will use these to look for substances (biomarkers Open a glossary item ) in the blood that may show how well tasquinimod is working, and to find out what happens to it in the body.

They will also ask for a sample of your cancer that was removed when you had surgery or a biopsy Open a glossary item and for extra blood samples. They will store these samples and may use them for future research. If you don’t want to give these samples for research, you don’t have to. You can still take part in the trial.

Hospital visits

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

A physical examination
Blood tests
Urine test
Heart trace (ECG )
CT scan or MRI scan
Ultrasound scan – only at some hospitals

If you have liver cancer, you will have 2 liver biopsies as part of this trial – one before treatment starts and another after 4 weeks. You must agree to these to take part in this trial.

During treatment you see the doctor every 2 weeks for a month, at 2 months and then every 2 months for a physical examination, blood tests and urine test. If you had an ultrasound, you have another one at the first 3 appointments. You have CT scans or MRI scans at the 2 month appointment and then every 2 months.

After treatment you see the doctor for the same tests apart from the ultrasound. You then see the doctor every 3 months.