Observational study of the effects of probenecid on the pharmacokinetics and pharmacodynamics of sorafenib (PROSORA-study) - PROSORA-studie

Erasmus MC Cancer Institute0 个研究点目标入组 16 人开始时间: 2017年8月16日最近更新: 2017年12月11日

适应症

试验速览

暂无简介。

•1.Age = 18 years
•2.Histological or cytological confirmed diagnosis of mRCC, HCC or differentiated thyroid carcinoma
•3.Start of sorafenib therapy, at least 7 days prior to start of the studyNB. Patients are allowed to have had previous sorafenib therapy or have started with sorafenib.
•4.WHO Performance Status = 2 (appendix D)
•5.Able and willing to sign the Informed Consent Form prior to screening evaluations
•6.Adequate organ function as defined by:
•a.Total bilirubin = 1.5 x ULN (except in case of documented Gilbert’s disease)
•b.ASAT = 3.0 x ULN (or = 5 x ULN if liver metastases are present)
•c.ALAT = 3.0 x ULN (or = 5 x ULN if liver metastases are present)
•d.Serum creatinin = 1.5 x ULN
•7.Adequate baseline patient characteristics (complete blood count, and serum biochemistry which involves sodium, potassium, creatinin, calculation of creatinin clearance (MDRD), amylase, lipase, calcium, phosphate, AST, ALT, gamma glutamyltranspeptidase (?-GT), lactate dehydrogenase (LDH), ALP, total bilirubin, albumin).
•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 12
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 4

•1.Use of drugs which may show an increased systemic exposure when taken concomitantly with probenecid. (see appendix C)
•2.Patients with known blood dyscrasias, uric acid kidney stones or until an acute gouty attack has subsided.
•3.Use of (over the counter) medication or (herbal) supplements which can interact with either sorafenib or probenecid, e.g. by induction or inhibition of CYP3A4, UGT1A9 (see appendix B and C)
•4.Unable or unwilling to abstain from grapefruit, grapefruit juice, herbal dietary supplements, and herbal tea during the study
•5.Previous use of probenecid during the last 2 weeks prior to sorafenib treatment
•6.Contraindications for use of probenecid such as acute gouty attack or porphyria.
•7.Unwilling to undergo a skin biopsy

发起方

Erasmus MC Cancer Institute