The Trial

Who can participate?

Patients aged 18 years and over with advanced pancreatic ductal adenocarcinoma. In total, the study aims to treat about 120 patients on the trial across the country at several hospitals.

What does the study involve?

The trial will combine VP-002 with two chemotherapies called nab- paclitaxel and gemcitabine, which are both standard treatments given to patients to treat their pancreatic ductal adenocarcinoma. The chemotherapies are given as a drip (infusion) every week, for three in every four weeks. VP- 002 is taken as a tablet twice a day. The study has two stages: in the first stage (Phase I trial), the goal is to work out the best doses of VP- 002 and the chemotherapies together. In the second stage (Phase II trial), the goal is to assess how well this new combination of VP-002 when given chemotherapy works compared to the standard chemotherapies without VP-002.

Phase 1

In the Phase I trial, everyone will be allocated a particular dose of VP-002 and the chemotherapy drugs. Different doses will be tried to select the best one by checking for any side effects, effects in the blood or the cancer tissue, any signs of cancer shrinkage and survival. Participants will be asked questions about their health and symptoms, looking for changes in blood tests using imaging scans and where possible, looking for changes inside the cancer itself by taking biopsies. They will be monitored closely throughout the treatment; this will involve extra tests and visits to the hospital, but the goal is to catch any side effects so they can be managed early.

Phase 2

In the Phase II trial, participants will be randomly split into two groups: some will receive all three drugs (VP-002 plus), and some will receive nab-paclitaxel plus gemcitabine chemotherapies that are used in standard care. This choice will be selected by a computer. After all the patients in the trial have finished treatment, we will compare the two groups to see which has better effectiveness.

The treatments will be given for 6 months initially and participants can be treated for more than this (up to a year) depending on the benefit and how the treatment is tolerated. Treatment may stop early if the drugs are causing bad side effects or not helping shrink the cancer. A detailed information sheet will be provided for potential volunteers who are interested in taking part.

If the addition of VP-002 to the standard chemotherapies nab-paclitaxel and gemcitabine looks more effective than just the standard chemotherapies alone, then the new combination may be further tested in larger studies to see whether it could become a new and approved option for treating patients with metastatic pancreatic ductal adenocarcinoma (mPDA).