optimal Duration of (fos)aprepitant prophylaxis for nausea and Vomiting INduced by ChemotherapY in childre

Phase 1

• Conditions: prolonged anti emetic treatment; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2021-003311-26-NL
• Lead Sponsor: Prinses Máxima Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-09
• Last Update Posted: 17 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

The eligibility criteria are:
- Patients must be = 6 months to = 18 years at time of study entry. and weight = 6kg
- Patients must have 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 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.
- 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.
- In patients on chronic warfarin, acenocoumarol, tolbutamide or phenytoin (me-tabolised by CYP2C9) therapy should be monitored closely during treatment with (fos)aprepitant and for 14 days following each course of (fos)aprepitant.
- No use of CYP3A4 substrates/inhibitors within 7 days, or no CYP3A4 inducers within 30 days of treatment
- Patient’s serum creatinine must be = 1.5 x institutional upper limit of normal (ULN) ac-cording to age.
- Patient’s AST and ALT must be = 5 x institutional ULN.
- Patient’s total bilirubin must be = 1.5 x institutional ULN
- Patient must not have a history of QT prolongation
- Female patients of childbearing potential must have a negative urine or serum preg-nancy 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 effec-tive 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 ab-sorption of the medication
Are the trial subjects under 18? yes
Number of subjects for this age range: 76
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

See E3

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified