EUCTR2017-002470-40-NL进行中（未招募）1 期
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:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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