NL-OMON45080RecruitingNot Applicable
Safety, feasibility and cost-effectiveness of genotype-directed individualized dosing of fluoropyrimidines - Genotype-directed individualized dosing of fluoropyrimidines (M14DPD)
Antoni van Leeuwenhoek Ziekenhuis0 sites1,250 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,250
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •1. Pathologically confirmed malignancy for which treatment with a fluoropyrimidine is considered to be in the patient*s best interest
- •2. WHO performance status of 0, 1 or 2
- •3. Life expectancy of at least 12 weeks
- •4. Able to swallow and retain oral medication
- •5. Able and willing to undergo blood sampling for pharmacogenetic and phenotyping analysis;For subgroup only:
- •6. Able and willing to undergo blood sampling and breath sampling at several time points
- •7. Able and willing to receive uracil for the test dose assay
- •8. Able and willing to receive [2-13C] -labeled uracil for the breath test
Exclusion Criteria
- •1. Prior treatment with fluoropyrimidines
- •2. Patients with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or the patient*s safety
- •3. Women who are pregnant or breast feeding
- •4. Both men and women who refuse to use reliable contraceptive methods throughout the study
- •5. Patients with a homozygous polymorphic genotype or compound heterozygous genotype for DPYD.
Investigators
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