NL-OMON50886招募中3 期
DAVINCY trial: optimal Duration of (fos)aprepitant prophylaxis for nausea and Vomiting INduced by ChemotherapY in children: a double-blind placebo-controlled crossover randomized phase III trial* - DAVINCY
Prinses Máxima Centrum voor Kinderoncologie0 个研究点目标入组 76 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 76
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
入选标准
- •these are the eligibility criteria:
- •- Age must be >= 6 months to <= 18 years at time of study entry and weight >=6kg
- •- a documented malignancy.
- •- Patients need to receive moderate or highly emetogenic chemotherapy blocks,
- •or chemotherapy not previously tolerated due to vomiting, for a minimum
- •duration of 4 days.
- •- Chemotherapy schedules need to contain two similar courses of chemotherapy,
- •which do not necessarily have to be consecutive courses.
- •- No symptomatic primary or metastatic CNS malignancy causing nausea or
- •- Patients do not receive scheduled blocks of chemotherapy containing
- •dexamethasone as part of anti-tumour treatment during the study period.
- •- Patients aged 16 and greater than 16y with a Karnofsky score of 60 or more or
- •patients aged 15y or less with a Lansky Play performance score of 60 or more.
- •- Patient must have a life expectancy of 3 months or more.
- •- Patients must not use antiemetic treatment within 48h before treatment (see
- •appendix B).
- •- Patients must not receive radiation therapy to the abdomen or pelvis in the
- •week before treatment.
- •- Patient must not use benzodiazepines or opioids initiated within 48h before
- •treatment, except for single doses of triazolam, temazepam, or midazolam.
- •- Continuation of chronic benzodiazepine or opioid therapy is permitted
- •provided it was initiated >=48 hours prior to study drug administration.
- •o In patients on chronic warfarin, acenocoumarol, tolbutamide or phenytoin
- •(metabolised by CYP2C9) therapy should be monitored closely during treatment
- •with (fos)aprepitant and for 14 days following each course of (fos)aprepitant.
- •o No use of CYP3A4 substrates/inhibitors within 7 days, or no CYP3A4 inducers
- •within 30 days of treatment (see appendix B).
- •- serum creatinine must be <= 1.5 x institutional upper limit of normal (ULN)
- •according to age.
- •- AST and ALT must be <= 5 x institutional ULN.
- •- total bilirubin must be <= 1.5 x institutional ULN
- •- no history of QT prolongation
- •- Female patients of childbearing potential must have a negative urine or serum
- •pregnancy test confirmed prior to enrollment.
- •-Female patients with infants must agree not to breastfeed their infants while
- •on this study.
- •-Male and female patients of child-bearing potential must agree to use a highly
- •effective method of contraception approved by the investigator during the
- •study, following the CTFG recommendations.
- •-Patients have no history of prior grade 3/4 allergic reaction to any of the
- •study drugs.
- •-Patients have no underlying gastrointestinal disease that may interfere with
- •the absorption of the medication.
排除标准
- •see eligibility criteria D4a.
研究者
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