E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with operable colorectal cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061451 |
E.1.2 | Term | Colorectal cancer |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main primary objective is to assess levels of anthocyanins and their metabolites achieved in biomatrices from patients following a seven-day course of oral Mirtoselect. Specifically, the following detailed aims are to be achieved:
• To measure the levels of anthocyanins in normal and malignant colorectal tissues. • To compare concentrations of anthocyanins achieved in tissues after three different oral dose levels of Mirtoselect. • To assess the levels of anthocyanins and their metabolites in peripheral venous circulation, urine and stool.
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E.2.2 | Secondary objectives of the trial |
• To study the ability of Mirtoselect to affect potential surrogate biomarkers of chemopreventive efficacy in the blood: levels of oxidative DNA adduct M1dG and of prostaglandin E2. • To study the ability of Mirtoselect to affect potential biomarkers of chemopreventive efficacy in normal and malignant target (colonic) tissue, including levels of oxidative DNA adduct M1dG, ii. levels of inducible COX-2, iii. levels of phosphorylated EGFR, iv. indicators of proliferation (e.g. Ki67), angiogenesis (e.g. CD 34) and apoptosis (e.g. caspase 3). • To compare background levels of these biomarkers in normal and malignant tissue.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 strong clinical suspicion of having a primary colorectal adenocarcinoma. • Patients with disease that is amenable to surgical resection.
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E.4 | Principal exclusion criteria |
• Patients unfit for general anaesthesia. • Patients with significant impairment of gastrointestinal function or absorption, or with active peptic ulcer disease • Patients unwilling or unable to comply with the protocol • Patients with abnormal liver function tests. • Patients who have undergone radiotherapy or chemotherapy within 4 weeks of tissue sampling.
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E.5 End points |
E.5.1 | Primary end point(s) |
Levels of anthocyanins and their metabolites achieved in colorectal tissue, urine and the perhipheral venous cirulation.
Levels of molecular biomarkers (including levels of oxidative DNA adduct M1dG, ii. levels of inducible COX-2, iii. levels of phosphorylated EGFR, iv. indicators of proliferation (e.g. Ki67), angiogenesis (e.g. CD 34) and apoptosis (e.g. caspase 3)). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Comparisons between different randomised dose levels |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of trial: last visit of last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |