A trial of INCB024360 for women who have a raised level of CA125 after treatment for ovarian, primary peritoneal or fallopian tube cancer

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

Cancer type:

Ovarian cancer

Status:

Closed

Phase:

Phase 2

This trial is looking at a new drug called INCB024360 for women who have a raised level of a marker called CA125 in their blood, after having a good response to chemotherapy for ovarian cancer, fallopian tube cancer or primary peritoneal cancer. These cancers are all treated in the same way, so when we use the term ovarian cancer in this summary, we are referring to all 3.

If ovarian cancer has spread outside the area surrounded by your hip bones, (your pelvis Open a glossary item), doctors usually treat it with chemotherapy. If there are no signs of any cancer remaining after the chemotherapy, the cancer is said to be in complete remission Open a glossary item.

After treatment, you may have blood tests to look for a marker called CA125 Open a glossary item. Having an increased amount of CA125 in your blood may mean that your cancer has come back. But you can have an increased level of CA125, without any other signs or symptoms of your cancer having come back. If this happens, doctors aren’t sure if you should have more treatment and if you do, what the best treatment is. Currently there is no standard treatment Open a glossary item for women in this situation.

In this trial, researchers are looking at a new drug called INCB024360 which may help your immune system to kill cancer cells.

The women taking part have been in complete remission after having chemotherapy for ovarian cancer. They now have an increased level of CA125, but no other signs or symptoms of cancer. The aim of the trial is to compare INCB024360 with a hormone treatment called tamoxifen to

  • See if women who take the trial drug live longer without any signs of their cancer coming back
  • Learn more about the side effects

Who can enter

You may be able to enter this trial if

  • You were diagnosed with ovarian cancer, fallopian tube cancer or primary peritoneal cancer that had spread outside your pelvis or to another part of your body (stage 3 or 4)
  • Your cancer responded well to chemotherapy with a platinum drug Open a glossary item and the level of CA125 in your blood was at a normal level for at least 3 months after you finished treatment
  • There are currently no signs of your cancer having come back
  • You have had 2 blood tests that show the level of CA125 in your blood is now increasing
  • There is a sample of your cancer removed during surgery or a biopsy that the trial team can study
  • 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 at least 18 years old
  • You are willing to use reliable contraception if you haven’t been through the menopause or had both your ovaries removed and there is any chance you could become pregnant

As well as the above, if you had ongoing treatment to stop your cancer coming back (maintenance treatment), you must have finished this at least 4 weeks ago if it was a taxane drug Open a glossary item such as paclitaxel, or 8 weeks ago if you were having a drug called bevacizumab. If you had another drug as maintenance treatment, the trial team will tell you how long ago you must have finished it.

You cannot enter this trial if you

  • Have had more than 1 type of chemotherapy for ovarian cancer (you may have also had maintenance treatment with drugs such as paclitaxel or bevacizumab)
  • Haven’t recovered from the side effects of other treatment unless they are mild
  • Have had radiotherapy to your chest in the last 3 months or have had a condition caused by radiotherapy to the chest called radiation pneumonitis
  • Have had radiotherapy to any other part of your body in the last 3 months and still have side effects
  • Have had major surgery in the last 4 weeks
  • Have certain types of autoimmune disease Open a glossary item – the trial doctor can advise you about this
  • Take other medication that can affect body substances called cytochrome P enzymes, or drugs that block other body proteins called UGT1A9 and monoamine oxidases – your doctor can advise you about this
  • Are already taking tamoxifen or you would not be able to take it for some reason
  • Take drugs that damp down your immune system including steroids Open a glossary item (steroid creams or inhalers are allowed)
  • Have had an organ transplant or a stem cell Open a glossary item or bone marrow transplant Open a glossary item using cells from a donor
  • Have had a type of drug reaction called serotonin syndrome – your doctor can advise you about this
  • Have high blood pressure that can’t be controlled with medication or have certain heart problems – the trial doctor can advise you about this
  • Have problems with your digestive system Open a glossary item that could affect how you swallow or absorb tablets
  • Have any other condition that the trial team think could make it unsafe for you to take part
  • Have HIV, hepatitis B or hepatitis C
  • Are pregnant or breastfeeding

Trial design

This phase 2 trial will recruit about 110 women. It is a randomised trial. The women taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Women in one group take INCB024360 tablets twice a day. Women in the other group take tamoxifen tablets twice day.

INCB024360 for women who have a raised level of CA125 after treatment for ovarian, primary peritoneal or fallopian tube cancer trial diagram

As long as you don’t have bad side effects, you can carry on having the treatment for as long as it helps you.

If you stop treatment because your cancer comes back, the trial team will ask you to have another biopsy Open a glossary item. They will study this sample to see if the drug has affected your cancer cells. You don’t have to have this biopsy if you don’t want to.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

  • Physical examination
  • Heart trace (ECG Open a glossary item)
  • Blood tests
  • Urine test
  • CT scan or MRI scan

You may also have a PET-CT scan. And you might need to have a bone scan or brain scan if your cancer had spread to these parts of your body before you had chemotherapy.

The trial team will get a sample of your cancer that was removed when you had surgery or a biopsy in the past. The researchers study this sample to see if they can tell whether your immune system was acting on your cancer.

You go to hospital after 2 weeks of treatment and then every 4 weeks after that. You have a physical examination and blood tests each time.

The trial team will ask you to keep a diary at home to note down when you take the tablets each day.

You have a heart trace after 2 weeks of treatment and then every 12 weeks after that. You have a CT or MRI scan every 8 weeks.

When you finish treatment, you see the trial team again and have a physical examination, blood tests, a heart trace and a CT or MRI scan. You see them again 1 month and 2 months later. They will then contact you every 3 months to find out how you are and whether you are having any other cancer treatment.

Side effects

As INCB024360 is a new drug, there may be side effects we don’t know about yet. The known side effects include

We have more information about the side effects of tamoxifen in our cancer drugs section.

The trial team will talk to you about all the possible side effects of both drugs before you agree to join the trial.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Rebecca Kristeleit

Supported by

Experimental Cancer Medicine Centre (ECMC)
Incyte Corporation
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 10816

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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