Optimizing tamoxifen therapy through the induction of CYP3A4, CYP2C and CYP2D6 mediated metabolism - Induction of tamoxifen metabolism

未提供0 个研究点目标入组 12 人开始时间: 2010年11月24日最近更新: 2012年3月19日

适应症

试验速览

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•Histological or cytological confirmed diagnosis of (invasive) breast cancer, for which treatment with tamoxifen monotherapy is indicated (to be evaluated by the treating physician);
•Use of tamoxifen monotherapy for at least 4 weeks (to guarantee steady-state) and willing to continue the treatment until the second day of pharmacokinetic analyses;
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Pregnant or lactating patients;
•Impossibility to take oral drugs;
•Serious illness or medical unstable condition requiring treatment, symptomatic CNS-metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent;
•Contra-indications for rifampicin and/or dextromethorphan use;
•Use of medications or dietary supplements known to induce or inhibit CYP2D6, CYP2C, CYP3A4 and/or P-glycoprotein;
•Unwillingness to abstain from grapefruit (juice), (herbal) dietary supplements, herbals, over-the-counter medication (except for paracetamol and ibuprofen) and other drugs known to seriously interact with CYP3A during the study period;
•Non-compliance

发起方

未提供