ACELARATE
Research type
Research Study
Full title
A Phase III, open label, multicentre randomised clinical study comparing Acelarin (NUC-1031) with Gemcitabine in patient with metastatic pancreatic carcinoma. (ACELARATE)
IRAS ID
166503
Contact name
Daniel Palmer
Contact email
Sponsor organisation
The Clatterbridge Cancer Centre NHS Foundation Trust
Eudract number
2014-004653-14
Duration of Study in the UK
2 years, 10 months, 30 days
Research summary
Pancreatic cancer remains the most lethal of solid tumours with little progress being made to improve patient outcomes over the past 30 years of research. The incidence in the UK is approximately 9,000 new cases per year and, with a 5 year survival remaining at just 3%, mortality approximates incidence. These dismal outcomes reflect:
1. Advanced stage at presentation such that only a minority of patients are suitable for surgery with curative intent;
2. High rates of recurrence even in those undergoing radical surgery;
3. Limited efficacy of systemic therapies.Gemcitabine has been a standard chemotherapy for these patients for more than 15 years, but drug resistance is common.
Acelarin has been developed to overcome the resistances, which are known to limit the effect of gemcitabine and works by preventing cancer cells from dividing by attacking their DNA (deoxyribonucleic acid) resulting in tumour cell death. Non-clinical and clinical studies have shown that Acelarin is more effective than gemcitabine because it is able to reach cancer cells by passive diffusion, is less easily degraded by the cancer cell, and delivers the monophosphate form of the active agent.
The primary purpose of this study is to investigate if Acelarin is more effective than gemcitabine in treating patients with metastatic pancreatic cancer.
The study will investigate if Acelarin treatment compared with gemcitabine therapy prolongs the life of patients. We will also evaluate how Acelarin compared with gemcitabine therapy reduce the effects of pancreatic cancer and investigate the safety of Acelarin. A further objective is to discover if blood and tumour tissue from pancreatic cancer patients contains possible proteins, which predict if treatment with Acelarin is better than using gemcitabine.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
15/EM/0095
Date of REC Opinion
7 Apr 2015
REC opinion
Further Information Favourable Opinion