CRISTAL-APC
Research type
Research Study
Full title
A multi-centre, open label Phase I/randomised Phase II study of VP-002, a C-C motif chemokine receptor 1 (CCR1) inhibitor, given orally in combination with nab-paclitaxel and gemcitabine (nPG) to patients with advanced pancreatic ductal adenocarcinoma
IRAS ID
1009418
Contact name
Bristi Basu
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust & The University of Cambridge
ISRCTN Number
ISRCTN16463547
Research summary
In 2018, over 10,000 people were diagnosed with pancreatic cancer in the UK, and sadly, surviving for 5 years after diagnosis is still unlikely. Many people are diagnosed when they already have widespread (metastatic) disease and the chance of survival to 5 years is even less.
CRISTAL-APC is a medical study (clinical trial) led by Cambridge University Hospitals and the University of Cambridge. It is testing a drug called VP-002, given as a tablet twice a day. This drug slows down cancer growth in the lab by changing the immune system inside the cancer. It was given previously to patients with other diseases.
The trial will combine VP-002 with a normal first set of treatments for metastatic pancreatic cancer. This is the chemotherapies, nab-paclitaxel and gemcitabine. These chemotherapies are given as a drip (infusion) nearly every week.
The study has two steps: in the first step (Phase 1 trial), the goal is to figure out the right doses of VP-002 and the chemotherapies. In the second step (Phase 2 trial), the goal is to compare how well this new combination works compared to the chemotherapies alone.
In the Phase I trial, everyone will be assigned a particular dose of VP-002 and the chemotherapy drugs. These doses could well be higher or lower than the doses eventually selected for the Phase 2 trial. We will select the best doses by checking for any side effects, for cancer shrinkage and survival. We will do this by using scans, looking for changes in blood tests and looking for changes inside the cancer itself with biopsies. In the Phase II trial, participants will be randomly split into two groups: a slightly bigger group will receive all three drugs; and a smaller group will receive the normal two chemotherapies only. Patients will know which group they are in. After all the patients in the trial have finished treatment, we will compare the two groups to see which is better.REC name
London - Surrey Borders Research Ethics Committee
REC reference
24/LO/0787
Date of REC Opinion
30 Dec 2024
REC opinion
Further Information Favourable Opinion