A phase 2 trial looking at a new drug called BPM31510, with or without gemcitabine, to treat advanced pancreatic cancer.
Full title: A phase 2 study of BPM31510 (Ubidecarenone) nanosuspension injection administered intravenously with or without gemcitabine as second or third line therapy in advanced pancreatic cancer patients.
Why is this trial being carried out?
This phase 2 clinical trial is for people who have advanced pancreatic cancer and chemotherapy treatments are not working for them. Advanced (or metastatic) cancer is cancer that has spread to other parts of the body away from the pancreas.
This clinical trial aims to find out how safe BPM31510 is, how well it works and learn more about any side effects. The trial will also look at whether BPM31510 is most effective if used by itself or together with gemcitabine treatment. Gemcitabine is a chemotherapy drug used to treat pancreatic cancer.
What does this trial involve?
In this clinical trial people taking part will be split into two groups. One group will just have BPM31510, while the other group will have BPM31510 together with gemcitabine treatment. Your study doctor will decide which of the two groups is most suitable for you to take part in.
BPM31510 is given as an intravenous infusion. An intravenous infusion is when liquid is given directly into your veins – you may hear this called a ‘drip’. The drip means that BPM31510 can be given as a slow, controlled dose over six days at a time.
The BPM31510 dose is split into two infusions a week, given over three days each time. You will receive the dose through a pump that the hospital set up for you. You can carry the pump around in a shoulder bag, so you can go home while you are having the infusion.
Most people will have an infusion of BPM31510 given over Tuesday, Wednesday and Thursday. This is followed by a second infusion given over Friday, Saturday and Sunday. For the first hour you receive an infusion of BPM31510 you will need to stay at the hospital so your medical team can monitor you. After this hour, you can go home with the pump. You will need to return to hospital for the last two hours of each infusion.
If you are having BPM31510 together with gemcitabine, you will begin having gemcitabine three weeks after starting to take BPM31510. You will then have gemcitabine every Monday through an intravenous infusion. This is carried out at the hospital and takes around 30 minutes each time.
You will have your first round of treatment for a total of six weeks. After this, your treatment will last for four weeks at a time. After 10 weeks (which is two rounds of treatment), you will have tests to check how you are feeling and to check how well the treatment is working. Your doctor will decide with you whether you should continue to take part in the clinical trial. If you do continue, the trial can last up to one year.
Who is the trial suitable for?
Before taking part in the trial you will need to have some tests to check it is suitable for you to take part. These tests may include a CT scan, MRI scan and a blood test, as well as a short questionnaire about your health.
- you have advanced (metastatic) pancreatic cancer and other treatments aren’t working
- you have had one but no more than two previous treatments for pancreatic cancer, which may include chemotherapy, radiotherapy or surgery
- you are willing to have routine tests at the hospital throughout the clinical trial
- tests show that you are well enough to take part in the trial.
If you are having BPM31510 together with gemcitabine, you need to have finished any previous gemcitabine treatment at least three months ago.
- your cancer has spread to your brain or spinal cord
- you have a lowered immune response (immunosuppression)
- you have had chemotherapy or radiotherapy less than 4 weeks ago
- you have not fully recovered from any previous treatment, such as chemotherapy, radiotherapy or surgery
- you have taken part in another clinical trial within the last 30 days
- you have a condition that affects how your blood clots. For example, you have had a blood clot, treatment to thin your blood, or have a low platelet count (which could be caused by chemotherapy) – your medical team can explain more about this
- you have had a significant bleed in the last 6 months, including spitting up blood, heavy nose bleeds or blood in your urine or poo
- you have a condition or disease that affects your heart and this is not controlled by medication – your medical team can explain more about this
- you have had another type of cancer in the last five years that you have not recovered from.
There may be other reasons for not being able to take part in this trial. It is important to speak to your medical team about whether this trial might be suitable for you.
Recruitment start date: February 2016
Recruitment end date: January 2019
Published: August 2018
Review date: August 2020
The BPM31510 trial is being carried out at:
- St Bartholomew’s Hospital, London
- Royal Free Hospital, London
- Beatson West of Scotland Cancer Centre, Glasgow
- Dr Propper, St Bartholomew’s Hospital, London
- Jeff Evans, Beatson West of Scotland Cancer Care, Glasgow
- Roopinder Gilmore, Royal Free Hospital, London
You can contact the trial centres by emailing:
St Bartholomew’s Hospital, London at email@example.com
Royal Free Hospital, London at firstname.lastname@example.org
Beatson West of Scotland Cancer Centre, Glasgow at Jeff.Evans@ggc.scot.nhs.uk
How to join a trial
Speak to your consultant about whether this trial is suitable for you.
If you have any questions about pancreatic cancer you can speak to one of our specialist nurses on our Support Line.
How to find out more
For further information about this trial please visit the ClinicalTrials.gov website.
For references used to develop this information please email us.