Trial Outcomes & Findings for Buccal Film Versus IV Injection Palonosetron for Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting (NCT NCT04592198)
NCT ID: NCT04592198
Last Updated: 2025-03-24
Results Overview
no emetic episode and no rescue medication during the first 24 hours after chemotherapy
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
first 24 hours after chemotherapy
Results posted on
2025-03-24
Participant Flow
Participant milestones
| Measure |
A (Buccal 0.25 Mg)
Palonosetron HCl Buccal Film 0.25 Mg
|
B (Buccal 0.5 Mg)
Palonosetron HCl Buccal Film 0.5 Mg
|
C (IV Injection 0.25 Mg)
IV palonosetron 0.25 Mg (ALOXI®)
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
6
|
|
Overall Study
COMPLETED
|
7
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Buccal Film Versus IV Injection Palonosetron for Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting
Baseline characteristics by cohort
| Measure |
A (Buccal 0.25 Mg)
n=7 Participants
Palonosetron HCl Buccal Film 0.25 Mg
|
B (Buccal 0.5 Mg)
n=8 Participants
Palonosetron HCl Buccal Film 0.5 Mg
|
C (IV Injection 0.25 Mg)
n=6 Participants
IV palonosetron 0.25 Mg (ALOXI®)
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 9.32 • n=5 Participants
|
53.9 years
STANDARD_DEVIATION 10.96 • n=7 Participants
|
59.8 years
STANDARD_DEVIATION 9.13 • n=5 Participants
|
58.8 years
STANDARD_DEVIATION 10.32 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
History of motion sickness
Yes
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
History of motion sickness
No
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
17 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: first 24 hours after chemotherapyno emetic episode and no rescue medication during the first 24 hours after chemotherapy
Outcome measures
| Measure |
A (Buccal 0.25 Mg)
n=7 Participants
Palonosetron HCl Buccal Film 0.25 Mg
|
B (Buccal 0.50 Mg)
n=8 Participants
Palonosetron HCl Buccal Film 0.5 Mg
|
C (IV Injection 0.25 Mg)
n=5 Participants
IV palonosetron 0.25 Mg (ALOXI)
|
|---|---|---|---|
|
Complete Acute Response
|
4 Participants
|
4 Participants
|
3 Participants
|
Adverse Events
A (Buccal 0.25 Mg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
B (Buccal 0.5 Mg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
C (IV Injection 0.25Mg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place