PORCUPINE2 STUDY
Research type
Research Study
Full title
A Mod ular, Pha se II, Open-Label, Multicentre Study to Assess the Preliminary Efficacy and Safety of RXC004, in Patients with Advanced Solid Tumours that have Progressed following Therapy with Current Standard of Care
IRAS ID
294490
Contact name
Catherine Carter
Contact email
Sponsor organisation
Redx Pharma Plc
Eudract number
2020-005804-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 29 days
Research summary
This is phase II study to evaluate the effectiveness and safety of RXC004 monotherapy (single medicine treatment) in advanced solid tumours that have progressed (become worse) after patients have already tried standard of care (UK standard) treatment. These patients require further effective treatment options for their condition.
Patients invited to participate in this study will have pancreatic ductal adenocarcinoma (PDAC) with a specific genetic mutation in the Wnt signalling pathway (a way for cells to communicate on molecular level) or biliary tract cancer (BTC). The Wnt signalling pathway plays an important role in formation of tumours and has been shown to be elevated in some cancers.
The study drug, RXC004, is a small molecule porcupine (PORCN) inhibitor (a molecule which stops the function of other molecules) which reduces Wnt signalling. This study is being done to primarily assess anti-tumour activity of RXC004.
There are drugs that are already available to treat PDAC and BTC. It is not known whether RXC004 will have any benefit for patients different from the treatment that patients would normally receive.
Approximately 40 patients will participate in this study as multiple treatment centres. RedX Pharma Plc is the Sponsor of this study.
REC name
North West - Haydock Research Ethics Committee
REC reference
21/NW/0039
Date of REC Opinion
11 Feb 2021
REC opinion
Favourable Opinion