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.

Trial details

Who runs it

Prinses Maxima Centrum voor Kinderoncologie B.V.

Trial code

EU 2024-517846-32-00

Record updated

2026. február 5.

Original description

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).Read full original descriptionShow less

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).

Inclusion: 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.

Exclusion: 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.

EU CTIS 2024-517846-32-00