Clinical trial · Interventional
Efficacy of Aprepitant (Emend®) in Children
Efficacy of Aprepitant (Emend®) in Children Receiving Highly Emetogenic Chemotherapy
NCT01661335CI-TRIAL-00050828completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to find out whether or not adding aprepitant(Emend®) to the standard therapy will help children who receive chemotherapy to have less nausea and vomiting.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
| Nausea | — | UNRESOLVED | — |
| Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ondansetron, dexamethasone, aprepitant | Drug | — | UNRESOLVED |
| Ondansetron, Dexamethasone, placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ondansetron, dexamethasone, aprepitant
- description
- Arm A: Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no longer than 5 days; dexamethasone 0.2mg/kg (max 10 mg) IV or PO daily for at least 3 days, but no longer than 5 days; and aprepitant 3 mg/kg (max 125 mg) PO on day 1, and aprepitant 2 mg/kg (max 80 mg) PO on days 2 and 3 during the first investigational antiemetic cycle. During the next investigational antiemetic cycle, members of this arm will be crossed-over into the placebo arm, where the aprepitant will be replaced by placebo and the dexamethasone dose will be increased to 0.4 mg/kg (max 20 mg) daily.
- interventionNames
- Drug: Ondansetron, dexamethasone, aprepitant
- type
- PLACEBO_COMPARATOR
- label
- Ondansetron, Dexamethasone, placebo
- description
- Arm B: Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no more than 5 days; dexamethasone 0.4 mg/kg (max 20 mg) IV or PO daily for at least 3 days, but no more than 5 days; and a PO placebo for 3 days during the first investigational antiemetic cycle. During the second cycle, members this group will be crossed-over to the experimental arm, where the placebo will be replaced by aprepitant and the dexamethasone will be decreased by 50%.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: under 20.99 years of age at enrollment Scheduled to receive two identical cycles of highly emetogenic\[1\] chemotherapy for treatment of a primary malignancy, including: Chemotherapy with any one or more of the following single agents in any combination: * Carboplatin * Carmustine \>250 mg/m2 * Cisplatin * Cyclophosphamide ≥1 g/m2 * Dactinomycin * High dose Methotrexate ≥ 5 g/m2 Or any of the following defined combinations: * Cyclophosphamide + anthracycline * Cyclophosphamide + etoposide * Cytarabine 150-200 mg/m2 + daunorubicin * Cytarabine 300 mg/m2 + etoposide * Cytarabine 300 mg/m2 + teniposide * Doxorubicin + ifosfamide * Doxorubicin + methotrexate 5 g/m2 * Etoposide + ifosfamide Exclusion Criteria: * Patients who have received aprepitant in the past. * Patients who demonstrate evidence of increased intracranial pressure.
References
Publications (0)
Data not yet available
No reference posted for this study.