ean Body Mass as a determinant of docetaxel pharmacokinetics and toxicity (LEANDOC) - LEANDOC

Radboud University Nijmegen Medical Centre0 个研究点开始时间: 2012年2月8日最近更新: 2016年9月26日

适应症

试验速览

暂无简介。

•1.Subject is at least 18
•2.Subject is able and willing to sign the Informed Consent Form prior to screen-ing evaluations
•3.Subject has been diagnosed with either breast or metastatic castration-resistant prostate carcinoma and will receive docetaxel treatment according to standard hospital protocol
•4.Subject has an live expectancy of 12 weeks or greater
•5.Absolute neutrophile count (ANC) > 1.5 x 109/L
•6.Platelet count > 100 x 109/L
•7.Serum creatinine = 2 x ULN
•8.Total bilirubin level < 1.5 x ULN
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•1.Moderate or severe liver impairment; [ALAT and/or ASAT = 1.5 ULN] and [AF = 2.5 ULN]
•2.Current therapy with any drug, dietary supplements, or other compounds, or have been used in the last 2 weeks prior to the docetaxel administration, known to inhibit or induce CYP3A4 as mentioned on the list in appendix A.
•4.Inability to understand the nature and extent of the study and the procedures required

发起方

Radboud University Nijmegen Medical Centre