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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.
EU CTIS ID: 2024-517846-32-00
What this study is testing
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).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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).
You likely can't join if
- 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.
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.