Trial Outcomes & Findings for Pilot Study of Olanzapine and Aprepitant to Prevent Nausea and Vomiting in Children Receiving Chemotherapy (NCT NCT02097823)
NCT ID: NCT02097823
Last Updated: 2017-03-30
Results Overview
Primary objective of this study is to determine the feasibility of recruitment and data collection for conducting a larger trial. Recruitment and data collection will be feasible if at least 20 subjects can be recruited in 1 year and there is a 90% form completion rate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Approximately 1 year after study opens, at the conclusion of data collection. Participants will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks. Data will be collected over 5 days during each cycle.
Results posted on
2017-03-30
Participant Flow
Participant milestones
| Measure |
Aprepitant First, Olanzapine Second
Will receive aprepitant (weight based dose, see below) in first cycle of chemotherapy and olanzapine (weight based dose, see below) in the second cycle of chemotherapy. All doses will be given starting 30 minutes before chemotherapy on day 1.
Olanzapine dosing:
\>60kg - 10mg orally daily for 4 doses 40-59.9kg - 5mg orally daily for 4 doses 20-39.9kg - 2.5mg orally daily for 4 doses \<20kg - 1.25mg orally daily for 4 doses
Aprepitant dosing:
\>40kg - 125mg orally on day 1, then 80mg orally daily on days 2,3 35-39.9kg - 80mg orally daily for 3 doses 20-34.9kg - 40mg orally daily for 3 doses \<20kg - 1.5-2mg/kg orally daily for 3 doses
Olanzapine
Aprepitant
|
Olanzapine First, Aprepitant Second
Will receive olanzapine (weight based dose, see below) in first cycle of chemotherapy and aprepitant (weight based dose, see below) in the second cycle of chemotherapy. All doses will be given starting 30 minutes before chemotherapy on day 1.
Olanzapine dosing:
\>60kg - 10mg orally daily for 4 doses 40-59.9kg - 5mg orally daily for 4 doses 20-39.9kg - 2.5mg orally daily for 4 doses \<20kg - 1.25mg orally daily for 4 doses
Aprepitant dosing:
\>40kg - 125mg orally on day 1, then 80mg orally daily on days 2,3 35-39.9kg - 80mg orally daily for 3 doses 20-34.9kg - 40mg orally daily for 3 doses \<20kg - 1.5-2mg/kg orally daily for 3 doses
Olanzapine
Aprepitant
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
4
|
|
Overall Study
COMPLETED
|
10
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Aprepitant First, Olanzapine Second
Will receive aprepitant (weight based dose, see below) in first cycle of chemotherapy and olanzapine (weight based dose, see below) in the second cycle of chemotherapy. All doses will be given starting 30 minutes before chemotherapy on day 1.
Olanzapine dosing:
\>60kg - 10mg orally daily for 4 doses 40-59.9kg - 5mg orally daily for 4 doses 20-39.9kg - 2.5mg orally daily for 4 doses \<20kg - 1.25mg orally daily for 4 doses
Aprepitant dosing:
\>40kg - 125mg orally on day 1, then 80mg orally daily on days 2,3 35-39.9kg - 80mg orally daily for 3 doses 20-34.9kg - 40mg orally daily for 3 doses \<20kg - 1.5-2mg/kg orally daily for 3 doses
Olanzapine
Aprepitant
|
Olanzapine First, Aprepitant Second
Will receive olanzapine (weight based dose, see below) in first cycle of chemotherapy and aprepitant (weight based dose, see below) in the second cycle of chemotherapy. All doses will be given starting 30 minutes before chemotherapy on day 1.
Olanzapine dosing:
\>60kg - 10mg orally daily for 4 doses 40-59.9kg - 5mg orally daily for 4 doses 20-39.9kg - 2.5mg orally daily for 4 doses \<20kg - 1.25mg orally daily for 4 doses
Aprepitant dosing:
\>40kg - 125mg orally on day 1, then 80mg orally daily on days 2,3 35-39.9kg - 80mg orally daily for 3 doses 20-34.9kg - 40mg orally daily for 3 doses \<20kg - 1.5-2mg/kg orally daily for 3 doses
Olanzapine
Aprepitant
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Pilot Study of Olanzapine and Aprepitant to Prevent Nausea and Vomiting in Children Receiving Chemotherapy
Baseline characteristics by cohort
| Measure |
Aprepitant First, Olanzapine Second
n=11 Participants
Will receive aprepitant (weight based dose, see below) in first cycle of chemotherapy and olanzapine (weight based dose, see below) in the second cycle of chemotherapy. All doses will be given starting 30 minutes before chemotherapy on day 1.
Olanzapine dosing:
\>60kg - 10mg orally daily for 4 doses 40-59.9kg - 5mg orally daily for 4 doses 20-39.9kg - 2.5mg orally daily for 4 doses \<20kg - 1.25mg orally daily for 4 doses
Aprepitant dosing:
\>40kg - 125mg orally on day 1, then 80mg orally daily on days 2,3 35-39.9kg - 80mg orally daily for 3 doses 20-34.9kg - 40mg orally daily for 3 doses \<20kg - 1.5-2mg/kg orally daily for 3 doses
Olanzapine
Aprepitant
|
Olanzapine First, Aprepitant Second
n=4 Participants
Will receive olanzapine (weight based dose, see below) in first cycle of chemotherapy and aprepitant (weight based dose, see below) in the second cycle of chemotherapy. All doses will be given starting 30 minutes before chemotherapy on day 1.
Olanzapine dosing:
\>60kg - 10mg orally daily for 4 doses 40-59.9kg - 5mg orally daily for 4 doses 20-39.9kg - 2.5mg orally daily for 4 doses \<20kg - 1.25mg orally daily for 4 doses
Aprepitant dosing:
\>40kg - 125mg orally on day 1, then 80mg orally daily on days 2,3 35-39.9kg - 80mg orally daily for 3 doses 20-34.9kg - 40mg orally daily for 3 doses \<20kg - 1.5-2mg/kg orally daily for 3 doses
Olanzapine
Aprepitant
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
10.5 years
n=5 Participants
|
14 years
n=7 Participants
|
11.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Diagnosis
Ewings
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Diagnosis
Osteosarcoma
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Diagnosis
Neuroblastoma
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Diagnosis
Hodgkins
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Diagnosis
Germ Cell Tumor
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Diagnosis
Histiocytic Sarcoma
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Diagnosis
Medulloblastoma
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Chemotherapy Regimen
Vincristine/Cyclophosphamide/Doxorubicin
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Chemotherapy Regimen
Cisplatin/Doxorubicin
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Chemotherapy Regimen
High Dose Methotrexate
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Chemotherapy Regimen
Cisplatin/Etoposide
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Chemotherapy Regimen
BEACOPP
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Chemotherapy Regimen
ABVE-PC
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Chemotherapy Regimen
Cisplatin/Bleomycin/Etoposide
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Chemotherapy Regimen
CHOP
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Chemotherapy Regimen
Cisplatin/Vincristine
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 1 year after study opens, at the conclusion of data collection. Participants will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks. Data will be collected over 5 days during each cycle.Primary objective of this study is to determine the feasibility of recruitment and data collection for conducting a larger trial. Recruitment and data collection will be feasible if at least 20 subjects can be recruited in 1 year and there is a 90% form completion rate.
Outcome measures
| Measure |
All Participants
n=27 Administered forms
Both intervention arms included
|
Olanzapine
Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
|
|---|---|---|
|
Feasibility of Recruitment and Data Collection.
|
70.4 percentage of completed forms
|
—
|
SECONDARY outcome
Timeframe: Participants will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks. Data will be collected over 5 days during each cycle.This will measure what percentage of patients have a complete response (no emesis or use of breakthrough medications) in the overall phase (0-120 hours).
Outcome measures
| Measure |
All Participants
n=13 Participants
Both intervention arms included
|
Olanzapine
n=14 Participants
Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
|
|---|---|---|
|
Complete Response in Overall Phase
|
23.1 percentage of participants with CR
|
28.6 percentage of participants with CR
|
SECONDARY outcome
Timeframe: Participants will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks. Data will be collected over 5 days during each cycle.This will measure what percentage of patients have a complete response (no emesis or use of breakthrough medications) in the acute phase (0-24 hours).
Outcome measures
| Measure |
All Participants
n=13 Participants
Both intervention arms included
|
Olanzapine
n=14 Participants
Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
|
|---|---|---|
|
Complete Response in Acute Phase
|
76.9 percentage of participants with CR
|
78.6 percentage of participants with CR
|
SECONDARY outcome
Timeframe: Participants will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks. Data will be collected over 5 days during each cycle.This will measure what percentage of patients have a complete response (no emesis or use of breakthrough medications) in the delayed phase (25-120 hours).
Outcome measures
| Measure |
All Participants
n=13 Participants
Both intervention arms included
|
Olanzapine
n=14 Participants
Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
|
|---|---|---|
|
Complete Response in Delayed Phase
|
23.1 percentage of participants with CR
|
28.6 percentage of participants with CR
|
SECONDARY outcome
Timeframe: Participants will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks. Data will be collected over 5 days during each cycle.Population: could only analyze cycles where subjects had returned completed forms
Good control of nausea will be ratings \<25 on visual analog scale by parents and \<2 on baxter retching faces scale by patients. Will look at the proportions of patients with good control of nausea. The visual analog scale ranged from 0-100, with 0 being no nausea and 100 being very very severe nausea. The Baxter retching faces scale ranged from 0-10 using only even numbers (0,2,4,6,8,10) and each number has a corresponding face depicting someone experiencing varying levels of nausea, with 0 being no nausea and 10 being a picture of face vomiting.
Outcome measures
| Measure |
All Participants
n=11 Participants
Both intervention arms included
|
Olanzapine
n=8 Participants
Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
|
|---|---|---|
|
Good Control of Nausea
Visual Analog Scale/Parents
|
54.5 percentage of participant w/good control
|
50 percentage of participant w/good control
|
|
Good Control of Nausea
BARF scale/Patients
|
54.5 percentage of participant w/good control
|
50 percentage of participant w/good control
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Ongoing, throughout the study. Will be fully evaluated in approximately 1 year, at the conclusion of data collection. Each patient will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks.Olanzapine will be considered tolerable if less than 10% of patients experience a grade III or IV adverse event attributable to olanzapine.
Outcome measures
| Measure |
All Participants
n=13 Participants
Both intervention arms included
|
Olanzapine
n=14 Participants
Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
|
|---|---|---|
|
Number of Participants With Adverse Events.
|
0 participants
|
0 participants
|
Adverse Events
Aprepitant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Olanzapine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aprepitant
n=15 participants at risk
Cycles where patients received aprepitant along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
|
Olanzapine
n=15 participants at risk
Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
|
|---|---|---|
|
Psychiatric disorders
Agitation
|
0.00%
0/15
|
13.3%
2/15 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place