Trial of olanzapine in children for control of chemotherapy induced nausea and vomiting

Phase 2

• Conditions: Health Condition 1: C00-D49- Neoplasms

• Registration Number: CTRI/2023/04/051505
• Lead Sponsor: ee Dupuis (The Hospital for Sick Children)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Planned receipt of Highly emetogenic chemotherapy and conditioning regimen for HSCT

2. Plan for inpatient admission from initiation of study drug till 24 hours of end of last study drug dose

3. Body weight for more and equal to 12.5 kg

4. Plasma laboratory parameters within 1 week prior to administration of first dose of study drug (Plasma creatinine within 1.5 times of upper limit of normal, Amylase within age appropriate limits, Plasma conjugated bilirubin within 3 times of upper limit of normal for age unless attributable to Gilbert syndrome, ALT less than 5 times of upper limit of normal)

5. Baseline ECG within 1 month prior to study drug administration without known clinically significant abnormality including pathologic prolongation of QTc

6. Negative pregnancy test (for female of childbearing age)

7. Agreed to practise abstinence or use contraception (for female of childbearing age)

8. A plan for round the clock administration of ondansetron, palonosetron or granisetron for antiemetic prophylaxis

9. English or Hindi speaking child with English or Hindi Speaking Parent/guardian

Exclusion Criteria

1. CNS malignancy (primary or secondary). CNS Leukemia in remission is allowed

2. Preexisting seizure disorder, cardiac arrythmia, baseline ECG abnormalities including QTc prolongation, uncontrolled diabetes mellitus, neuroleptic malignant syndrome, known hypersensitivity or allergy to olanzapine

3. Treatment within 14 days of study drug administration with olanzapine or other anti-psychotic agents (eg risperidone, quetiapine, aripiprazole, clozapine, butyrophenone) including those used for control of vomiting (Chlorpromazine, Prochlorperazine, promethazine)

4. Scheduled administration of any antiemetic other than dexamethasone, ondansetron, granisetron or palonosetron)

5. Receipt of cranial boost radiation within 14 days

6. Planned coadministration of medications like citalopram, amifostine, and medications known to alter metabolism of olanzapine (ciprofloxacin, valproate)

7. Previous participation in this trial

8. Participants in optional nausea assessment should be free of cognitive, visual and hearing impairment that precludes the completion of PeNAT

Study & Design

• Study Type: Interventional
• Study Design: Not specified