"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial of 2-hydroxyoleic acid for people with a solid tumour that has spread (Minerval study)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a drug called 2-hydroxyoleic acid which is also known as 2OHOA or Minerval. The trial is for people who have a
More about this trial
Doctors use treatments such as surgery, chemotherapy, hormone therapy and biological therapy to treat cancer. But sometimes cancers continue to grow despite having all the
2OHOA is a fatty acid related to olive oil. We know from laboratory research that 2OHOA stops the growth of cancer cells. This trial is the first time it has been tested in people with cancer.
The aims of the trial are to
- Find the best dose of 2OHOA
- Learn about the side effects
- See what happens to 2OHOA in the body
- Find out how well 2OHOA works for different types of cancer
Who can enter
You may be able to join this trial if you have 1 of the following
- A solid tumour (not a
lymphomaor leukaemia) that has spread to another part of your body and has got worse despite having standard treatment, or there is no standard treatment you can have
- Grade 3 or 4 glioma brain tumour and your cancer has grown despite previous treatment
As well as the above, all of the following must apply. You
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Have cancer that can be measured by a scan
- Have satisfactory blood test results
- Are able to swallow the trial drug which is a liquid
- Are willing to use reliable contraception during the trial and for 6 months afterwards if there is any chance that you or your partner could become pregnant
You cannot join this trial if any of these apply. You
- Have had chemotherapy, radiotherapy, biological therapy or treatment in a trial in the last 4 weeks
- Have had surgery in the last 2 weeks
- Have had radiotherapy to treat a single area of cancer spread in the last 2 weeks (there may be some exceptions to this which the trial team can advise you about)
- Are still having side effects from any anti cancer treatment, apart from hair loss or tiredness
- Have had bleeding in your brain picked up by a CT scan or MRI scan (you may be able to take part if you have had treatment for this)
- Have any other medical condition that the trial doctor thinks could affect your taking part
- Are allergic to the drugs used in this trial, anything they contain, or similar drugs
- Are pregnant or breastfeeding
This is a phase 1 /2 trial. There are 2 parts to the trial.
In part 1, the researchers are trying to find out the best dose to give. They aim to recruit up to about 30 patients. The first few patients taking part have a low dose of 2OHOA. If they don’t have any serious side effects, the next few patients have a higher dose. And so on, until they find the best dose to give. This is called a dose escalation study.
In part 2, the researchers want to learn more about the side effects of 2OHOA and how it affects cancer. This part will recruit about 10 patients with glioma and 10 patients with a
You drink 2OHOA as a liquid. It comes in a bottle as powder. When you are due to take it, you add tap water to dissolve the powder and drink it straight away.
Your trial doctor will tell you how much 2OHOA you take, how often and when (probably between 30 minutes to 2 hours after food). The researchers expect that most people will have this drug twice a day.
As long as you don’t have any serious side effects, you may have 2OHOA for as long as it is helping you.
You see the doctors and have some tests before you start treatment. The tests include
- Blood and urine tests
- Physical examination
- Heart trace (
- Heart scan (
echocardiogram) or MUGA scan
- CT scan or MRI scan
The researchers may ask for a sample of your cancer that was removed when you had surgery or a
When you start taking 2OHOA every day, you go to hospital every week for the first few weeks. If you don't have any serious side effects, this can then reduce to about every 11 days. For some hospital visits, the trial team will ask you not to eat or drink anything (apart from water) from the night before. You will take your 2OHOA at hospital and have some blood tests afterwards.
At each visit, you see a doctor who will ask you about any side effects you’ve had. You have blood tests and you may have other tests at some of these appointments. The trial team will give you more information about this.
You have a CT or MRI scan 6 weeks after you start treatment, then every 2 to 3 months for the rest of the time you have 2OHOA.
The researchers may take a biopsy of your cancer 2 times during treatment. If you join the 1st part of the trial, you don't have to have these biopsies. If you join the 2nd part and have any cancer other than a glioma, you must agree to have the biopsies.
When you finish treatment, you see the trial team again about a month later. You have a physical examination, blood and urine tests, ECGs and a CT scan or MRI scan. You may have further visits to see the trial team if you are still having side effects.
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.
Professor Ruth Plummer
Experimental Cancer Medicine Centre (ECMC)
Lipopharma Therapeutics SL