PHARMACODYNAMIC STUDY OF ORAL MIRTOSELECT IN PATIENTS WITH SUSPECTED COLORECTAL DISEASE

Phase 1

• Conditions: Patients with operable colorectal cancer; MedDRA version: 8.1Level: LLTClassification code 10061451Term: Colorectal cancer

• Registration Number: EUCTR2006-004226-82-GB
• Lead Sponsor: niversity Hospitals of Leicester NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-18
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified