Onderzoek naar de farmacokinetiek van uracil na orale toediening bij patiënten met colorectaal carcinoom. - KINURA-2
- Conditions
- Colorectal cancerMedDRA version: 12.1Level: LLTClassification code 10010036Term: Colorectal carcinoma
- Registration Number
- EUCTR2009-017620-11-NL
- Lead Sponsor
- Scheper Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
•age > 18 years
•Metabolized disease
•Signed informed consent
•DPD activity in PBM = 6 nmol/mg/hour
•Live expectation > 3 months
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
•DPD activity in PBM < 6 nmol/mg/uur
•Pregnancy
•The use of Cimetidine (drug-drug interactions)
•GFR <50 ml/min (Cockcroft&Gault formula)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine that de PK of an oral uracil loading dose in patients with colorectal cancer and normal DPD activity does not differ from the PK in healthy volunteers.<br><br>;Secondary Objective: ;Primary end point(s): inclusion of 18 patients
- Secondary Outcome Measures
Name Time Method