NL-OMON39781已完成4 期
ean Body Mass as a determinant of docetaxel pharmacokinetics and toxicity (LEANDOC) - LEANDOC
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subject is at least 18;
- •2. Subject is able and willing to sign the Informed Consent Form prior to screen-ing evaluations;
- •3. Female subject diagnosed with breast carcinoma and will receive docetaxel treatment according to standard hospital protocol (TAC regimen) or male subject diagnosed with metastatic castration-resistant prostate carcinoma and will receive docetaxel treatment according to standard hospital protocol (PRODOC regimen)
- •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;
排除标准
- •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.;
- •3. Inability to understand the nature and extent of the study and the procedures required;
研究者
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