Patients with operable liver metastases MedDRA version: 8.1 Level: LLT Classification code 10024700 Term: Liver metastases
Conditions
Sponsors
University Hospitals of Leicester NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients must be over 18 years of age. • Patients must be of sound mind to give written informed consent • Patients must have a high likelihood of a diagnosis of primary or secondary liver malignancy. • All patients must have disease amenable to surgical resection. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients unfit for general anaesthesia. • Patients with significant impairment of gastrointestinal function or absorption • Patients unwilling or unable to comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To measure the levels of anthocyanins and metabolites achieved in normal and malignant liver tissue after administration of Mirtoselect. Levels will be assessed after administration of a 7-day course of oral Mirtoselect at three dosing levels. To compare the levels of anthocyanins and their metabolites achieved in blood, urine, bile and hepatic tissue determined analytically at the three doses of Mirtoselect administered ;Secondary Objective: To study the potential effects of Mirtoselect on levels of PGE-2 (COX-2 activity) in blood and of M1dG (oxidation status) in blood lymphocytes To explore the potential effects of Mirtoselect on markers of proliferation (e.g., Ki-67) and apoptosis (e.g., cleaved caspase 3) in normal and malignant liver tissue. ;Primary end point(s): Levels of anthocyanins and their metabolites acheived in liver tissue, urine, perhiperal venous blood and bile. Levels of molecular biomarkers (including levels of the oxidative DNA adduct M1dG, ii. levels of inducible COX-2, iii. levels of phosphorylated EGFR, iv. indicators of proliferation (eg. Ki67) and apoptosis (eg caspase 3)). | — |
Countries
United Kingdom
Outcome results
None listed