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=99 Participants
|
53.9 years
STANDARD_DEVIATION 10.96 • n=107 Participants
|
59.8 years
STANDARD_DEVIATION 9.13 • n=206 Participants
|
58.8 years
STANDARD_DEVIATION 10.32 • n=7 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
History of motion sickness
Yes
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
1 participants
n=206 Participants
|
4 participants
n=7 Participants
|
|
History of motion sickness
No
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
5 participants
n=206 Participants
|
17 participants
n=7 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