PROSPECT-R
Research type
Research Study
Full title
PROSPECT-R: A Prospective Translational Study Investigating Molecular Predictors of Resistance and Response to Regorafenib monotherapy in RAS Mutant Metastatic Colorectal Cancer
IRAS ID
150241
Contact name
David Cunningham
Contact email
Sponsor organisation
Royal Marsden NHS Foundation Trust
Eudract number
2014-003579-51
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Colorectal cancer is one of the commonest cancers in the world. Although treatment options have improved in recent years, the outcome from un-resectable and/or metastatic colorectal cancer (mCRC) (i.e. cancer with secondaries that have spread beyond the bowel) remains poor with high mortality and 5-year survival of less than 5%. Previous studies have shown that tumours survive by having their own blood supply through a process called angiogenesis. One of the proven treatment strategies in management of mCRC includes using agents that can block the blood supply of the tumour (anti-angiogenic therapy). Regorafenib is an oral small molecule which targets the blood supply of the tumour in addition to targeting multiple other key signalling proteins responsible for colorectal cancer progression. In a large clinical trial, regorafenib has shown improvement in survival of the patients who had failed on all previous lines of chemotherapy. There are however currently no biomarkers to identify the patients who are likely to benefit from regorafenib or any other anti-angiogenesis therapies like bevacizumab and aflibercept (used in management of colorectal cancer). Keeping in view the cost implications and potential side effects from these treatments, it is an area of un-met need to identify biomarkers of response and resistance to these therapies so that only the patients who are likely to gain benefit are offered these treatments. PROSPECT-R is an exploratory prospective translational research study to obtain research biopsies of mCRC tumour tissue prior to commencement of Regorafenib treatment and again at development of resistance;and at 8 weeks from treatment, in patients who show response or disease control on the treatment. Additionally serial research blood specimens will be collected every four weeks during treatment. The aim of the study will be to identify novel predictive biomarkers of resistance and response to regorafenib therapy .
REC name
London - Fulham Research Ethics Committee
REC reference
14/LO/1812
Date of REC Opinion
5 Nov 2014
REC opinion
Further Information Favourable Opinion