Safety, feasibility and cost-effectiveness of genotype-directed individualized dosing of fluoropyrimidines - Genotype-directed individualized dosing of fluoropyrimidines

etherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI-ALV)0 个研究点目标入组 1,250 人开始时间: 2014年12月18日最近更新: 2018年8月20日

适应症

试验速览

暂无简介。

•1.Pathologically confirmed malignancy for which treatment with a fluoropyrimidine is considered to be in the patient’s best interest
•2.Age ? 18 years
•3.Able and willing to give written informed consent
•4.WHO performance status of 0, 1 or 2
•5.Life expectancy of at least 12 weeks
•6.Able to swallow and retain oral medication
•7.Able and willing to undergo blood sampling for pharmacogenetic and phenotyping analysis
•8.Minimal acceptable safety laboratory values
•a.ANC of ? 1.5 x 109 /L
•b.Platelet count of ? 100 x 109 /L
•c.Hepatic function as defined by serum bilirubin ? 1.5 x ULN, ALAT and ASAT ? 2.5 x ULN; in case of liver metastases ALAT and ASAT ? 5 x ULN.
•d.Renal function as defined by serum creatinine ? 1.5 x ULN or creatinine clearance ? 60 ml/min (by Cockcroft-Gault formula).
•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 650
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 600

•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 (adequate contraceptive methods are: condom, sterilization, other barrier contraceptive measures preferably in combination with condoms)
•5. Patients with a homozygous polymorphic genotype or compound heterozygous genotype for DPYD.

发起方

etherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI-ALV)