NUC-3373 in Advanced Solid Tumours
Research type
Research Study
Full title
A three part, Phase I/II dose escalation and expansion study to assess the safety, pharmacokinetics and clinical activity of NUC-3373, a nucleotide analogue, in participants with advanced solid tumours.
IRAS ID
_185166
Contact name
Sarah Blagden
Contact email
Eudract number
2015-002250-13
Duration of Study in the UK
1 years, 6 months, 20 days
Research summary
Fluorouracil (5-FU) is the backbone of therapy for a variety of different solid tumours for the last fifty years, however there is still a significant demand for more efficacious and better tolerated systematic therapies.
NUC-3373 has been specifically designed to overcome the cancer resistance mechanism associated with 5-FU, it is likely to be more potent in tumour cells and therefore could be given at a lower dose to achieve efficacy with less off-target toxicity.
The primary purpose of this study is to establish the recommended phase 2 dose (RP2D) for NUC-3373 in combination with leucovorin. This will be achieved by splitting the study into 3 parts. Parts 1 and 2 will be used to evaluate 2 different dosing schedules. Based on the data collected in Parts 1 and 2, an optimum dosing schedule will be selected to use in Part 3 when NUC-3373 will be combined with leucovorin.REC name
London - West London & GTAC Research Ethics Committee
REC reference
15/LO/1467
Date of REC Opinion
22 Sep 2015
REC opinion
Unfavourable Opinion