Onderzoek naar de farmacokinetiek van uracil na orale toediening bij patiënten met colorectaal carcinoom. - KINURA-2

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-017620-11-NL

Enrollment

Registered

2010-01-20

Start date

2011-06-14

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Colorectal cancer MedDRA version: 12.1 Level: LLT Classification code 10010036 Term: Colorectal carcinoma

Interventions

Product Name: Uracil Pharmaceutical Form: Powder and solvent for oral suspension

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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. ;Secondary Objective: ;Primary end point(s): inclusion of 18 patients	—

Countries

Netherlands

Outcome results

None listed

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