VALENCIA
Research type
Research Study
Full title
An open label, single arm, Phase I/II study of vandetanib - eluting radiopaque embolic beads (BTG-002814) in patients with hepatocellular carcinoma (HCC) without curative options
IRAS ID
232325
Contact name
Tim Meyer
Contact email
Sponsor organisation
Biocompatibles UK Ltd
Eudract number
2017-002517-64
Duration of Study in the UK
1 years, 6 months, 17 days
Research summary
This is a phase I/II dose escalation, cohort expansion study of BTG-002814 in patients with hepatocellular carcinoma (HCC) cancer in the liver without curative options.
BTG-002814 is made up of tiny, radiopaque beads loaded with an anti-cancer treatment called vandetanib. It is injected in to an artery carrying blood to the liver tumour(s). The beads lodge in the blood vessels that the tumour uses for its blood supply, stopping blood flow and access to oxygen and nutrients for the cancer cells. They then release high doses of the anti-cancer drug in and around the tumour where it can reach any remaining cancer cells and kill them. BTG-002814 beads are radiopaque which means they can be seen by X-ray enabling us to make sure that they have been delivered to the tumour.
The study is divided in to 2 parts. In part A we are trying to find the safest dose for BTG-002814 and in Part B we are testing the dose further to see if it is safe and could help in the treatment of liver cancer.
Approximately 12 patients will be recruited in part A. We will include 3 patients initially. After these 3 patients have completed the study, we will look at how they have done and decide if it is safe to continue to treat another 3 patients at a higher dose.
In part B we will recruit approximately 44 patients. We will look at how patients have done in Part A and decide which dose is safe to treat patients in part B.
We also plan to look at BTG-002814 to study blood markers, looking at certain features in the blood which may help identify suitable patients for this therapy in the future.
The study will take place at approximately 7 sites across Europe.REC name
London - Chelsea Research Ethics Committee
REC reference
17/LO/1750
Date of REC Opinion
15 Dec 2017
REC opinion
Further Information Favourable Opinion