2024-517846-32-00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.
Prinses Maxima Centrum voor Kinderoncologie B.V.1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2024年11月15日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- The proportion of patients who achieved complete response (defined as no vomiting, no retching and no use of rescue medication) during the >24-72 hours after the final dose of chemotherapy (delayed phase).
研究概览
简要总结
To evaluate the effect of prolonged duration of (fos)aprepitant prophylaxis on the prevention of delayed CINV (complete remission in the 24-72 hours after the final dose of chemotherapy) in children using moderate or highly emetogenic chemotherapy. The current 3-day regimen is followed by placebo and compared to a regimen of (fos)aprepitant prophylaxis during the complete course of chemotherapy (maximum of 8 days) in a double-blind fashion and with a randomized cross-over design in which the patient functions as its own control in 2 similar chemotherapy cycles (of 8 days) (not necessarily consecutive courses).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Age must be ≥ 6 months to ≤ 18 years at time of study entry.
- •Patients do not receive scheduled blocks of chemotherapy containing corticosteroids as part of anti-tumour treatment during the study period.
- •Patients aged greater than 16y with a Karnofsky score of 60 or more or patients aged 16y 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).
- •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.
- •Patients must not receive radiation therapy to the abdomen or pelvis in the week before treatment.
- •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.
- •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.
- •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.
- •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 vomiting.
排除标准
- •Only hemato-oncology patients on dexamethasone therapy and symptomatic primary or meta-static CNS malignancy patients causing nausea or vomiting are excluded from study participation.
结局指标
主要结局
The proportion of patients who achieved complete response (defined as no vomiting, no retching and no use of rescue medication) during the >24-72 hours after the final dose of chemotherapy (delayed phase).
The proportion of patients who achieved complete response (defined as no vomiting, no retching and no use of rescue medication) during the >24-72 hours after the final dose of chemotherapy (delayed phase).
次要结局
- Cost-effectiveness of prolonged (fos)aprepitant dosing regimen.
- Proportion of patients who: - achieved complete response during the course of chemotherapy until 24h after the final dose of chemotherapy (acute phase) - achieved complete response during both the acute and delayed phase (overall phase)
- Time from initiation of emetogenic chemotherapy to: 1. the first vomiting episode 2. the first rescue medication use
- Safety of prolonged use of (fos)aprepitant (AEs considered related by the investigators).
- Pharmacokinetic (PK) parameters (i.e. clearance and volume of distribution) and influ-encing PK co-variates as chemotherapeutics.
- Improvement of CINV complaints according to the Pediatric Nausea Assessment tool (PeNAT) and the Baxter Retching Faces (BARF).
- Validity, responsiveness and feasibility of PeNAT and BARF.
研究者
Dr. E. de Vos- Kerkhof
Scientific
Prinses Maxima Centrum voor Kinderoncologie B.V.
研究点 (1)
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