A trial looking at VP-002 and chemotherapy for advanced pancreatic cancer (CRISTAL-APC)
Cancer type:
Status:
Phase:
This trial is looking at adding VP-002 to gemcitabine and nab-paclitaxel chemotherapy.
It is for people who:
- have pancreatic cancer that has spread to other parts of the body (
advanced cancer 
) - are enrolled in another pancreatic cancer study called Precision-Panc
More about this trial
You might have gemcitabine and nab-paclitaxel to treat advanced pancreatic cancer. This is a . Doctors are looking for ways to improve treatment for this group of people. In this trial they are looking at a new drug called VP-002.
VP-002 is a . It blocks a protein called CCR1. Blocking this protein can help to slow down cancer growth. Doctors think that having VP-002 with chemotherapy can improve how well chemotherapy works.
This is the first time people with advanced pancreatic cancer are having VP-002. There are 2 parts to this trial. In part 1, everyone will have VP-002 with nab-paclitaxel and gemcitabine. In part 2 some people have VP-002 with gemcitabine and nab-paclitaxel. And some people have gemcitabine and nab-paclitaxel.
The main aims of the trial are to find out:
- the best dose of VP-002 to have
- how safe it is to have VP-002 in combination with gemcitabine and nab-paclitaxel
- how well VP-002 and chemotherapy work together
- what the side effects are
- more about
quality of life
Who can enter
The following bullet points are a summary of 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.
Who can take part
You may be able to join this trial if all of the main entry following apply. You:
- have ductal adenocarcinoma of the pancreas that has spread elsewhere in the body
- have cancer that your doctor can measure on a scan
- have satisfactory blood test results
- are fit and active but might not be able to do heavy physical work (performance status 0 or 1)
- are willing to use reliable contraception during the trial and for a period after if there is any chance you or your partner could become pregnant
- are enrolled in the Precision-Panc study
- are at least 18 years old
As well as the main entry conditions above, to join part one of the trial, the following must also apply. You:
- have an area of cancer that the trial doctor can take a tissue sample (
biopsy ) from - are suitable to have gemcitabine and nab-paclitaxel
- have had a previous tissue sample taken that the trial team can use
As well as the main entry conditions above, to join part two, the following must also apply. You have:
- a previous tissue sample available that the trial team can use which was taken within 2 years of joining this trial
- not had any previous treatment for pancreatic cancer that has spread to other parts of the body or you have had treatment that was completed at least six months ago
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
- have pancreatic cancer that has spread into surrounding tissues or you can have surgery to remove the cancer
- are taking part in another treatment trial. You might be able to join if you are in a trial that doesn’t involve a treatment.
- have another cancer. You might be able to take part if you had successfully treated
carcinoma in situ of the cervix or non melanoma skin cancer . You might also be able to take part if you have had treatment for another cancer in the past, there have been no signs of it for at least 2 years and it has a low risk of coming back. - are not enrolled onto the Precision-Panc study
Medical conditions
You cannot join this trial if any of these apply. You:
- have a serious
lung problem . Your doctor will check for this before you can join the trial. This includes chronic obstructive airways disease or significant shortness of breath at rest. - have had a heart attack in the last 6 months, another significant
heart problem that needs treatment or you have a heart rhythm change - have had a
stroke in the last 6 months - have
liver cirrhosis - have an active hepatitis B or hepatitis C infection or another active infection
- have a blood clot and you aren’t taking medication to thin the blood or you have had a significant bleed within 3 weeks of being put into a treatment group
- have another medical condition or mental health condition that could affect you taking part or the trial doctor doesn’t think you will be suitable for this trial
Other
You cannot join this trial if any of these apply. You:
- are allergic to gemcitabine, nab-paclitaxel, VP-002 or anything they contain
- are pregnant, plan to become pregnant or you are breastfeeding
As well as the above main exclusions conditions you can’t join part 1 if:
- you have mild to moderate side effects from past chemotherapy for pancreatic cancer that has spread. You can take part if you have hair loss or moderate numbness or tingling in your hands or feet. You might also be able to take part if you have a low level of
red blood cells and haven’t needed a blood transfusion within 28 days of joining this study.
As well as the above main exclusion conditions, you can’t join part 2 if:
- you have already had chemotherapy for pancreatic cancer that has spread into surrounding tissues or to another part of the body. You may be able to join if you had
systemic treatment just before or after surgery and you completed it at least 6 months ago. - you have mild to moderate side effects from previous treatment for cancer that you had before or after surgery. You can take part if you have hair loss or moderate numbness or tingling in your hands or feet. You might also be able to take part if you have a low level of red blood cells and haven’t needed a blood transfusion within 28 days of joining this study.
Trial design
This is a phase 1/2 trial. It has 2 parts. The team need 120 people to take part in total.
Part 1 is looking at the best dose of VP-002 to have with chemotherapy. This is the dose escalation part.
Part 2 is testing this dose in more people. This is the dose expansion part.
VP-002 is a tablet. You have gemcitabine and nab paclitaxel as a drip into a vein.
You have . Each cycle lasts for 28 days. Everyone has treatment for up to one year. You have this for as long as it is working and the side effects aren’t too bad.
You stop treatment if your cancer gets worse. Your doctor will talk to you about other treatment options.
Part one (this is open to recruitment)
Everyone in this part has VP-002 with gemcitabine and nab paclitaxel chemotherapy.
In the first cycle of treatment, you have only VP-002. You take a single dose of VP-002 on day 1 of the first cycle. And then you take them twice a day, every day from day 2 to 14. You don’t have chemotherapy in the first cycle.
From cycle 1 onwards, you take VP-002 twice a day every day. You have gemcitabine and nab-paclitaxel once a week for three weeks.
The first person taking part will have a low dose of VP-002. If they don’t have any serious side effects, the next person will have a higher dose. And so on, until they find the best dose. This is called a dose escalation study. You stay on the same dose level for the trial.
The trial team will let you know how many VP-002 tablets to take.
Part two (this isn’t open to recruitment)
This part of the trial is randomised. A computer puts you into a treatment group. Neither you nor your doctor can decide which group you are in.
There are 2 treatment groups. You have one of the following:
- VP-002 with gemcitabine and nab-paclitaxel
- gemcitabine and nab-paclitaxel
You have the best dose of VP-002 found in part one. You take VP-002 tablets twice a day, every day. You have gemcitabine and nab-paclitaxel once a week for three weeks.
Samples for research (part 1 and part 2)
The team ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.
The researchers might also ask to take a tissue sample () if there isn’t a previous sample that they can use. If it is possible and safe to do so, you have some extra tissue samples taken. This is during the trial and when you stop treatment.
You don’t have to have all the samples taken if you don’t want to. The team will talk to you about this and what it involves.
They plan to use the samples to:
- see how well the treatment is working
- look at
genes to understand more about pancreatic cancer - look for substances called
biomarkers to help work out why treatment might work for some people and not for others
The team will also ask your permission to store some samples for future research. You don’t have to agree to this.
Quality of life (part 2 only)
The trial team will ask everyone joining part 2 to fill in some questionnaires:
- before you start treatment
- at set times during and after treatment
The questionnaires ask about side effects and how you’ve been feeling. This is called a quality of life study.
Trial treatment diary
You fill in a diary to record when you take your VP-002 tablets. You must bring the diary card to all hospital visits for the trial team to review.
Food diary
The team will ask you to keep a 24 hour food diary. You fill this in at specific times during the trial. The team will tell you when this is. You use the food diary to record everything that you eat or drink for a 24 hour period.
You fill in the diary on paper, on an or on both. The app is called Intake24. The team can tell you more about the app and how to use it. They can help you with it if you need help.
Hospital visits
You see the doctor for a and to have some tests before you can take part. These include:
- blood tests
- urine tests
- a heart trace (ECG)
- a CT scan or MRI scan
During treatment you see the doctor regularly. This is for blood tests and to see how you are.
The hospital visits in part one take between 4 and 8 hours. This depends on what treatment or tests you are having at each visit. The hospital visits in part 2 take about 4 hours. Some of these visits might take a bit longer.
Trial scans
You have a CT scan or MRI scan once every 2 months. You stop having the trial scans if your cancer gets worse.
Follow up
When you stop treatment, the team check to see how you are getting on. You see them within 2 weeks to a month after you stop treatment.
You then see them once a month if your cancer doesn’t get worse. This is for up to a year. You stop having these visits if your cancer gets worse or you start another treatment.
When you stop having follow up visits, a member of the trial team may check your medical notes to see how you are getting on.
Side effects
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
Only a few hundred people have had VP-002 so there may be side effects we don’t know about yet.
The most common side effects we know about so far include:
- an increase in the amount of fats in the blood
- an increase in the time it takes for blood to clot
- a drop in blood cells leading to an increased risk of infection
- feeling or being sick
- bloating or flatulence (farting)
- flu-like symptoms
- drowsiness or tiredness (fatigue)
- back pain
- headaches
- dark or green poo
- sweating
- diarrhoea
- loss of appetite
- sore throat
- vertigo or dizziness
- tummy (abdominal) discomfort or stomach pain
We have more information about gemcitabine and nab-paclitaxel.
Location
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.
Chief Investigator
Dr Bristi Basu
Supported by
Cambridge University Hospitals NHS Foundation Trust
Cycle Pharmaceuticals
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
