Ireland
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Starting soon Phase 3

Olanzapine for Prevention of Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy

NCT07035821 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2025-07-01
Last updated
2025-06-25

Condition(s) studied

Breakthrough Chemotherapy-Induced Vomiting (CIV) in Pediatric PatientsPediatric Cancer

Investigational drug(s) / intervention(s)

Olanzapine Tablets →Placebo

Olanzapine Tablets: Oral olanzapine tablets

Placebo: Oral placebo

Study summary

Breakthrough chemotherapy-induced vomiting (CIV) is defined as CIV occurring after adequate antiemetic prophylaxis. Olanzapine is recommended for the treatment of breakthrough CIV in children, without adequate evidence. We conducted an open-label, single-center, phase 3 randomized controlled trial comparing the safety and efficacy of olanzapine and metoclopramide for treating breakthrough CIV.

Eligibility

Sex
ALL
Min age
5 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: \- The major inclusion criteria were children aged 5 to 18 years at the time of study entry with documented cancer; receiving NK-1 inhibitor (aprepitant/fosaprepitant) and 5HT-3 antagonist (ondansetron) and/or dexamethasone as prophylactic antiemetics for CINV due to MEC or HEC; minimum body weight of 10 kg; development of breakthrough vomiting after starting prophylactic antiemetics; Lansky performance scale of above 50 (for patients aged 10 years or less) or Eastern Cooperative Oncology Group performance scale less than 3 and normal electrocardiogram (ECG) before the initiation of the prophylactic antiemetics. Exclusion Criteria: * Children with history of allergy to olanzapine or metoclopramide; patient with renal failure, congestive heart failure, or any uncontrolled disease except for malignancy; serum creatinine more than upper limit of normal (ULN) for age; serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) four times the ULN for age and serum bilirubin 1.5 times ULN for age; patient with history of central nervous system disease including brain metastasis, seizure disorder, or psychosis; patients on treatment with other antipsychotic agents such as risperidone, quetiapine, clozapine, or phenothiazine.

Primary outcome measure(s)

  • the CR rate for vomiting in the first 72 hours — in the first 72 hours of the initiation of olanzapine
    The primary endpoint was the CR rate for vomiting in the first 72 hours of the initiation of olanzapine .

Trial sites (1)

FacilityCityRegionStatus
Shanghai Children's Medical Center Shanghai China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07035821 on ClinicalTrials.gov ↗ ← All trials in China