A trial looking at a new drug called LY2940680 and paclitaxel for advanced cancer (HIPROC)

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

Cancer type:

All cancer types
Ovarian cancer

Status:

Closed

Phase:

Phase 1/2

This trial is for people with solid tumours including ovarian cancer that has come back or treatment has stopped working. A solid tumour Open a glossary item is any cancer apart from leukaemia or lymphoma.

Cancer Research UK supports this trial.

More about this trial

Researchers are looking for new ways to treat people with advanced cancer Open a glossary item that is getting worse despite treatment. In this trial, they are looking at LY2940680 and a chemotherapy drug called paclitaxel.

LY2940680 is a type of biological therapy Open a glossary item called a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

This trial is in 2 parts. The 1st part is for people with any solid tumour and the 2nd part is for women only with

These cancers are treated in a similar way. When we use the term ovarian cancer in this summary, we are referring to all 3.

The aims of the trial are

  • to find the highest safe dose of LY2940680 to give with paclitaxel
  • to learn more about the side effects

Who can enter

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

You might be able to join this trial if all of the following apply. You

  • Have an advanced solid tumour and standard treatment Open a glossary item has stopped working or your doctor thinks you are suitable to have weekly paclitaxel
  • Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Have satisfactory blood test results
  • Are willing to use reliable contraception during treatment and for 6 months afterwards if there is any chance that you or your partner could become pregnant
  • Are at least 18 years old

As well as the above, if you are joining part 2, the following must also apply.

  • You have a serous type ovarian cancer that is high grade Open a glossary item or a high grade endometriod epithelial ovarian cancer, fallopian tube or primary peritoneal cancer that has spread into surrounding tissues or to another part of the body
  • Your cancer got worse or came back within 6 months of having platinum chemotherapy Open a glossary item
  • You have had at least 1 type of platinum chemotherapy in the past
  • The trial team can have a sample of tissue taken when you had a biopsy Open a glossary item or your surgery for ovarian cancer, and there is no reason why you can’t have another biopsy
  • You haven’t had weekly paclitaxel for cancer that has come back in the past

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

  • Have cancer that has spread to the brain or spinal cord
  • Have cancer that has spread to the membranes surrounding the brain (leptomeningeal carinomatosis)
  • Have a type of ovarian cancer known as mucinous or clear cell
  • Have had moderate to severe numbness or tingling in your hands (peripheral neuropathy Open a glossary item) or feet in the past
  • Have taken any medication that blocks an enzyme called CYP3A4 in the 7 days before joining this trial
  • Have had LY2940680 or a similar drug
  • Can’t swallow tablets
  • Have problems with your heart, such as a heart attack in the last 6 months, high blood pressure that is not well controlled, angina that is not well controlled, an abnormal rhythm of your heart, congestive heart failure, fluid around you heart or severe peripheral vascular disease (restriction in the flow of blood to your legs)
  • Have a blockage in your bowel or any problem with your digestive system that would affect how you absorb the drug
  • Have a bad infection and need antibiotics as a drip into a vein
  • Have a condition called syndrome of inappropriate antiduretic hormone secretion (SIADH) or a problem with your adrenal glands Open a glossary item
  • Have had experimental treatment as part of a clinical trial or any other treatment within a month of joining this trial
  • Are allergic or sensitive to any of the drugs used in this trial
  • Are known to have HIV, hepatitis B or hepatitis C
  • Are pregnant or breastfeeding

Trial design

This is a phase 1/2 trial. The trial is in 2 parts. The trial team need between 9 and 18 people to join part 1 and 12 women to join part 2.

Everyone will have LY2940680 and weekly paclitaxel.

In part 1, the first few people will have a low dose of LY2940680. If they don’t have any serious side effects, the next few people will have a higher dose. And so on, until they find the best dose. This is called a dose escalation study.

LY2940680 is a tablet. You take it once every day. The dose you have depends on which group you join.

You have paclitaxel as a drip into a vein once a week for 3 weeks out of 4.

You have paclitaxel for 6 months. You continue with LY2940680 for as long it is helping you and the side effects aren’t too bad.

When the best dose of LY2940680 has been found, part 2 of the trial can begin. In part 2, you take LY2940680 once every day and paclitaxel as described above.

Samples for research
The researchers will ask for a sample of your cancer that was removed when you had surgery or a biopsy Open a glossary item.

If you have ovarian cancer, they might also ask you to have 2 more biopsies during the trial. You don’t have to give these extra samples if you don’t want to. You can still take part in the trial.

The researchers might also ask to take extra blood tests during the first month of the trial. Where possible you have these at the same time as your routine blood tests. The researchers want to find out what happens to LY2940680 in the body (pharmacokinetics Open a glossary item).

Hospital visits

You see trial doctors and have some tests before you start treatment. These include

  • A physical examination
  • Urine tests
  • Blood tests
  • Heart trace (ECG [Gloss/ECG)
  • CT scan or MRI scan

You go to hospital to have paclitaxel. You should not need to stay overnight.

You have a CT or MRI scan every 2 months.

When you finish treatment, you see the trial team again 4 weeks later. You will have some of the tests you had at the beginning of the trial and a CT or MRI scan.

The trial team will continue to follow you up every 2 months to see how you are getting on. This might be at a routine hospital appointment or they might check your medical notes.

Side effects

LY2940680 is a new drug so there might be side effects we don’t know about yet. The trial team will monitor you during the time you have treatment and they will give you a phone number to call them if you are worried about anything. So far, the most common side effects of LY2940680 include

You mustn’t eat certain foods during the trial as they can affect how LY2940680 works. This includes grapefruit and Seville oranges. You will be given more information about this by the trial team.

We have information about the side effects of paclitaxel.

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 Ros Glasspool

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Ignyta Inc
NHS Greater Glasgow and Clyde
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12213

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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