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*

Phase 3

Recruiting

• Conditions: chemotherapy induced nausea and vomiting; 10027656

• Registration Number: NL-OMON50886
• Lead Sponsor: Prinses Máxima Centrum voor Kinderoncologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 76

Inclusion Criteria

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
vomiting.
- 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.

Exclusion Criteria

see eligibility criteria D4a.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Proportion of patients who achieve complete response (no vomiting, no retching<br /><br>and no use of rescue medication) during the 24-72 hours after the final dose of<br /><br>chemotherapy (delayed phase).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Proportion of patients who:<br /><br>- achieved complete response during the course of chemotherapy until 24h af-ter<br /><br>the final dose of chemotherapy (acute phase)<br /><br>- achieved complete response during both the acute and delayed phase (overall<br /><br>phase)<br /><br><br /><br>Time from initiation of emetogenic chemotherapy to:<br /><br>o the first vomiting episode<br /><br>o the first rescue medication use<br /><br><br /><br>Safety of prolonged use of (fos)aprepitant (AEs considered related by the<br /><br>investiga-tors)<br /><br>Pharmacokinetic (PK) parameters (i.e. clearance and volume of distribution) and<br /><br>in-fluencing PK co-variates as chemotherapeutics<br /><br>Improvement of CINV complaints according to the Pediatric Nausea Assessment<br /><br>tool (PeNAT) for children aged 4-<=18 years<br /><br>Cost-effectiveness of prolonged (fos)aprepitant dosing regimen </p><br>