An intervention study of the effects of probenecid on the pharmacokinetics and pharmacodynamics of sorafenib (PROSORA-study) - PROSORA-study

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 16 人开始时间: 待定最近更新: 2024年4月15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 but nog longer than 14 days prior to start of the study NB. 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. Adequate liver function before start of sorafenib (to be determined by the oncologist)
•b. 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).

•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
•8. Body mass index (BMI) beneath 8.5 or above 35

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