RCT of Olanzapine for Control of CIV in Children Receiving Highly Emetogenic Chemotherapy
NCT ID: NCT03118986
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2017-08-10
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Olanzapine
Standard antiemetics plus olanzapine
Olanzapine
olanzapine 0.1 mg/kg/dose (maximum 10 mg/dose) by mouth as a single daily dose based on actual body weight
Placebo Oral Tablet
Standard antiemetics plus placebo
Placebo Oral Tablet
Placebo tablets that look like olanzapine and will be dosed as if they are olanzapine
Interventions
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Olanzapine
olanzapine 0.1 mg/kg/dose (maximum 10 mg/dose) by mouth as a single daily dose based on actual body weight
Placebo Oral Tablet
Placebo tablets that look like olanzapine and will be dosed as if they are olanzapine
Eligibility Criteria
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Inclusion Criteria
Plan for inpatient admission from administration of first study drug dose until 24 hours following administration of last study drug dose.
Body weight of at least 12.5 kg
2.5 to \< 18 years of age. Note that the minimum age requirement corresponds to an approximate body weight of 12.5 kg.
Samples for all laboratory tests will be obtained within one week prior to administration of the first chemotherapy dose of the study chemotherapy block or the first HSCT conditioning dose:
* Plasma creatinine within 1.5 times the upper limit of normal for age.
* Amylase within age-appropriate limits
* Plasma conjugated bilirubin within ≤ 3x upper limit of normal for age unless attributable to Gilbert's Syndrome
* ALT ≤ 5x upper limit of normal for age
Baseline ECG within the month prior to study drug administration without known clinically significant abnormalities including pathologic prolongation of QTc
A plan for scheduled, round-the-clock receipt of ondansetron, granisetron or palonosetron for antiemetic prophylaxis during administration of chemotherapy or HSCT conditioning.
Negative pregnancy test if female of childbearing potential
Patients of childbearing potential must consent to use adequate contraception (males and females) or agree to practice abstinence
Parent or child able to speak a language in which the (modified Pediatric Adverse Event Rating Scale (PAERS) is available.
Optional: Child participants in the optional assessment of nausea severity must be 4 to 18 years of age. Child and a parent/guardian must be English, Spanish or French-speaking. The Pediatric Nausea Assessment Tool58 (PeNAT) is validated in English-speaking children 4 to 18 years old with an English-speaking parent/guardian and has been translated into Spanish and French. The MAT is available in English, Spanish and French.
30 Months
18 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Children's Mercy Hospital Kansas City
OTHER
St. Justine's Hospital
OTHER
Columbia University
OTHER
Medical University of South Carolina
OTHER
CancerCare Manitoba
OTHER
University of North Carolina, Chapel Hill
OTHER
Nationwide Children's Hospital
OTHER
The Hospital for Sick Children
OTHER
Responsible Party
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Lee Dupuis
Principal Investigator
Principal Investigators
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Lee Dupuis, RPh, PhD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Muhammad Ali, MD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Locations
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University of California
San Francisco, California, United States
The Children's Mercy Hospital
Kansas City, Missouri, United States
Columbia University/Morgan Stanley Children's Hospital
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Cancer Care Manitoba
Winnipeg, Manitoba, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Centre Hospitalier Universitaire Sainte-Justine,
Montreal, Quebec, Canada
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
Countries
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Central Contacts
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Facility Contacts
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Judy Vun
Role: primary
Shanta Salzer
Role: primary
References
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Dupuis LL, Taddio A, Kerr EN, Kelly A, MacKeigan L. Development and validation of the pediatric nausea assessment tool for use in children receiving antineoplastic agents. Pharmacotherapy. 2006 Sep;26(9):1221-31. doi: 10.1592/phco.26.9.1221.
Other Identifiers
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1000053716
Identifier Type: -
Identifier Source: org_study_id
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