Trial Outcomes & Findings for Olanzapine for Prevention of Chemotherapy-induced Nausea and Vomiting in Children: A Multi-Centre Feasibility Study (NCT NCT02129478)

Results Overview

Our primary study outcome evaluated the feasibility of a future trial of olanzapine that would evaluate the contribution of olanzapine to chemotherapy-induced nausea and vomiting (CINV) control in pediatric oncology patients. A future trial was considered feasible if the following patient outcomes were met: mean time to enroll 15 patients was 12 months or less per site, 12 or more patients took at least half of the planned olanzapine doses, and 3 or less patients experienced significant sedation or dizziness despite dose reduction.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

1 year

Results posted on

2020-04-07

Participant Flow

Participant milestones

Participant milestones
Measure	Olanzapine Olanzapine: Patients will receive olanzapine once daily starting just before the first dose of chemotherapy within the study chemotherapy block and continuing until discharge from hospital or for a maximum of 4 doses after the last dose of chemotherapy. Olanzapine will be dosed at 0.14mg/kg/dose (maximum 10mg/dose) as a single daily oral dose rounded to the nearest increment of a half-tablet (2.5mg).
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Olanzapine for Prevention of Chemotherapy-induced Nausea and Vomiting in Children: A Multi-Centre Feasibility Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Olanzapine n=15 Participants Olanzapine: Patients will receive olanzapine once daily starting just before the first dose of chemotherapy within the study chemotherapy block and continuing until discharge from hospital or for a maximum of 4 doses after the last dose of chemotherapy. Olanzapine will be dosed at 0.14mg/kg/dose (maximum 10mg/dose) as a single daily oral dose rounded to the nearest increment of a half-tablet (2.5mg).
Age, Categorical <=18 years	15 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	11.1 years n=99 Participants
Sex: Female, Male Female	9 Participants n=99 Participants
Sex: Female, Male Male	6 Participants n=99 Participants
Region of Enrollment Canada	15 Participants n=99 Participants

PRIMARY outcome

Timeframe: 1 year

Our primary study outcome evaluated the feasibility of a future trial of olanzapine that would evaluate the contribution of olanzapine to chemotherapy-induced nausea and vomiting (CINV) control in pediatric oncology patients. A future trial was considered feasible if the following patient outcomes were met: mean time to enroll 15 patients was 12 months or less per site, 12 or more patients took at least half of the planned olanzapine doses, and 3 or less patients experienced significant sedation or dizziness despite dose reduction.

Outcome measures

Outcome measures
Measure	Olanzapine n=15 Participants Olanzapine: Patients will receive olanzapine once daily starting just before the first dose of chemotherapy within the study chemotherapy block and continuing until discharge from hospital or for a maximum of 4 doses after the last dose of chemotherapy. Olanzapine will be dosed at 0.14mg/kg/dose (maximum 10mg/dose) as a single daily oral dose rounded to the nearest increment of a half-tablet (2.5mg).
Patient Outcomes Participants enrolled at 12 months	15 Participants
Patient Outcomes Patients taking half olanzapine doses at 12 months	15 Participants
Patient Outcomes Patients with sedation or dizziness at half dose	0 Participants

SECONDARY outcome

Timeframe: During the acute (24 hours) and delayed (7 days after acute phase) phases, up to 2 weeks

The proportion of children achieving complete CINV control (no nausea, vomiting, or retching and no use of breakthrough antiemetic agents) during the acute (24 hours after the last dose of chemotherapy is administered) and delayed phases (the 7 days following the acute phase) will be described. The duration of assessment will depend on the number of days each individual patient receives chemotherapy. Nausea will be assessed using the Pediatric Nausea Assessment Tool (PeNAT).

Outcome measures

Outcome measures
Measure	Olanzapine n=15 Participants Olanzapine: Patients will receive olanzapine once daily starting just before the first dose of chemotherapy within the study chemotherapy block and continuing until discharge from hospital or for a maximum of 4 doses after the last dose of chemotherapy. Olanzapine will be dosed at 0.14mg/kg/dose (maximum 10mg/dose) as a single daily oral dose rounded to the nearest increment of a half-tablet (2.5mg).
Proportion of Patients With Complete CINV Control	0 Participants

SECONDARY outcome

Timeframe: Every day for 30 days after the last dose of the study drug

All early discontinuation of olanzapine or dose reduction cases will be reported.

Outcome measures

Outcome measures
Measure	Olanzapine n=15 Participants Olanzapine: Patients will receive olanzapine once daily starting just before the first dose of chemotherapy within the study chemotherapy block and continuing until discharge from hospital or for a maximum of 4 doses after the last dose of chemotherapy. Olanzapine will be dosed at 0.14mg/kg/dose (maximum 10mg/dose) as a single daily oral dose rounded to the nearest increment of a half-tablet (2.5mg).
Number of Participants With Adverse Events as a Measure of Safety and Tolerability # patients with reduced dose	6 Participants
Number of Participants With Adverse Events as a Measure of Safety and Tolerability # patients with drug discontinuation	2 Participants

Adverse Events

Olanzapine

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Olanzapine n=15 participants at risk Olanzapine: Patients will receive olanzapine once daily starting just before the first dose of chemotherapy within the study chemotherapy block and continuing until discharge from hospital or for a maximum of 4 doses after the last dose of chemotherapy. Olanzapine will be dosed at 0.14mg/kg/dose (maximum 10mg/dose) as a single daily oral dose rounded to the nearest increment of a half-tablet (2.5mg).
Nervous system disorders Sedation	40.0% 6/15 • Number of events 6
Eye disorders Blurry vision	6.7% 1/15
Blood and lymphatic system disorders Increased plasma GGT values	6.7% 1/15
General disorders Mild dizziness	13.3% 2/15
General disorders Mild orthostatic hypotension	6.7% 1/15
Cardiac disorders Hypertriglyceridemia	6.7% 1/15

Additional Information

Dr. Laura Lee Dupuis

The Hospital for Sick Children

Phone: 416-813-7654

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place