PHARMACODYNAMIC STUDY OF ORAL MIRTOSELECT IN PATIENTS WITH SUSPECTED COLORECTAL DISEASE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004226-82-GB

Enrollment

Unknown

Registered

2006-09-18

Start date

2006-09-07

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with operable colorectal cancer MedDRA version: 8.1 Level: LLT Classification code 10061451 Term: Colorectal cancer

Interventions

Trade Name: Mirtoselect Pharmaceutical Form: Powder for oral solution INN or Proposed INN: Anthocyanidins CAS Number: 84082-34-8 Concentration unit: % percent Concentration type: equal Concentration n

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 strong clinical suspicion of having a primary colorectal adenocarcinoma. • Patients with disease that is 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, 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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. ;Secondary Objective: • 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. ;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)).	—

Measure

Time frame

Main Objective: 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. ;Secondary Objective: • 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. ;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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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026