|Funding||NuCana BioMed Limited|
A Phase III, open label, multicentre randomised clinical trial comparing Acelarin with Gemcitabine in patients with metastatic pancreatic carcinoma.
Once screening investigations have confirmed eligibility, patients will be randomised and commence treatment within 2 weeks of the date of randomisation. They will be randomly allocated onto one of two possible treatment arms:-
1. Experimental Arm: Acelarin: 825 mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle
2. Control Arm: Gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle.
In both arms, treatment will continue until progression of disease, unacceptable toxicity or withdrawal of consent.
Participation in the study will be until withdrawal of consent or death. Patients will be assessed every 12 weeks for tumour response until disease progression by having a CT scan.
Primary outcome measure:
To assess whether Acelarin is superior to Gemcitabine in terms of overall survival for treatment of patients with metastatic pancreatic carcinoma.
Secondary outcome measures:
To compare between the two treatment groups:
- Progression Free Survival
- Radiological Response and disease control rate
- Toxicity and safety
- Quality of Life
Additional, exploratory objectives are to discover possible biomarkers to predict additional benefit of Acelarin over gemcitabine. This will be explored by laboratory tests on the blood samples and tumour samples that are taken from the patients on the study.