A Phase 2 interventional study of Palonosetron Hydrochloride Buccal Film 0.25 Mg and Palonosetron Hydrochloride Buccal Film 0.5 Mg in Nausea With Vomiting Chemotherapy-Induced, sponsored by Xiamen LP Pharmaceutical Co., Ltd. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-24.
Sponsored by Xiamen LP Pharmaceutical Co., Ltd · Phase 2, Interventional, and Prevention
Phase 2 study to compare efficacy, safety and PK of palonosetron, a long acting 5-HT3 receptor antagonist, by buccal film delivery compared to iv injection for chemotherapy induced nausea or vomiting (CINV). Subjects receive a single dose of palonosetron prior to moderately emetogenic chemotherapy.
This is a Phase 2 study to compare efficacy, safety and PK of palonosetron, a long acting 5-HT3 receptor antagonist, by buccal film compared to iv injection for moderately emetogenic chemotherapy-induced nausea or vomiting (CINV) in cancer patients. Subjects are randomized into three treatment groups, two with the experimental study drug palonosetron in buccal film at one of two different doses or the control treatment using Palonosetron hydrochloride iv injection. Palonosetron PK will be assessed in a subgroup of each treatment group.
822 studies on the registry are indexed under Nausea; 104 are open to participants now.
This study's enrollment of 22 is below the median of 115 across 703 interventional studies indexed under Nausea.
Browse Nausea studies →Xiamen LP Pharmaceutical Co., Ltd is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
With histologically or cytologically confirmed malignant disease;
-. Be scheduled to receive the first course of MEC to be administered on Day 1
Exclusion Criteria:
Palonosetron HCl Buccal Film 0.25 Mg
Drug: Palonosetron Hydrochloride Buccal Film 0.25 Mg
Palonosetron HCl Buccal Film 0.5 Mg
Drug: Palonosetron Hydrochloride Buccal Film 0.5 Mg
IV palonosetron 0.25 Mg (ALOXI®)
Drug: Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution
Dose equal to the iv control
Also known as: Buccal Film Low Dose
Dose twice that of iv control
Also known as: Buccal Film High dose
iv control
Also known as: Control Standard Treatment (Aloxi)
Complete Acute Response
no emetic episode and no rescue medication during the first 24 hours after chemotherapy
Time frame: first 24 hours after chemotherapy
| Milestone | A (Buccal 0.25 Mg) | B (Buccal 0.5 Mg) | C (IV Injection 0.25 Mg) |
|---|---|---|---|
| Started | 8 | 8 | 6 |
| Completed | 7 | 8 | 6 |
| Not completed | 1 | 0 | 0 |
no emetic episode and no rescue medication during the first 24 hours after chemotherapy
| Participants | A (Buccal 0.25 Mg) | B (Buccal 0.50 Mg) | C (IV Injection 0.25 Mg) |
|---|---|---|---|
| Complete Acute Response | 4 | 4 | 3 |
Collected over Adverse event reporting begins from the time of informed consent to the end of that last visit (Visit 5, Day 9 (for non-PK group)/ Day 11 (for PK group)).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| A (Buccal 0.25 Mg) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| B (Buccal 0.5 Mg) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| C (IV Injection 0.25Mg) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
One subject in Group A withdrew consent and was withdrawn (no additional information was provided).
| Age, Continuous(years) | A (Buccal 0.25 Mg) | B (Buccal 0.5 Mg) | C (IV Injection 0.25 Mg) | Total |
|---|---|---|---|---|
| Mean | 63.4 ± 9.32 | 53.9 ± 10.96 | 59.8 ± 9.13 | 58.8 ± 10.32 |
| Sex: Female, Male(Participants) | A (Buccal 0.25 Mg) | B (Buccal 0.5 Mg) | C (IV Injection 0.25 Mg) | Total |
|---|---|---|---|---|
| Female | 5 | 5 | 6 | 16 |
| Male | 2 | 3 | 0 | 5 |
| Race (NIH/OMB)(Participants) | A (Buccal 0.25 Mg) | B (Buccal 0.5 Mg) | C (IV Injection 0.25 Mg) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 | 2 |
| White | 5 | 8 | 4 | 17 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 1 | 1 |
| History of motion sickness(participants) | A (Buccal 0.25 Mg) | B (Buccal 0.5 Mg) | C (IV Injection 0.25 Mg) | Total |
|---|---|---|---|---|
| Yes | 1 | 2 | 1 | 4 |
| No | 6 | 6 | 5 | 17 |
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Xiamen LP Pharmaceutical Co., Ltd