Phase 2
N=22
Buccal Film Versus IV Injection Palonosetron for Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting
Nausea With Vomiting Chemotherapy-Induced
Bottom Line
View on ClinicalTrials.gov: NCT04592198 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Complete Acute Response — 4; 4; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Palonosetron Hydrochloride Buccal Film 0.25 Mg (Drug); Palonosetron Hydrochloride Buccal Film 0.5 Mg (Drug); Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Xiamen LP Pharmaceutical Co., Ltd
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Acute Response |
4; 4; 3 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- With histologically or cytologically confirmed malignant disease;
-. Be scheduled to receive the first course of MEC to be administered on Day 1
- Using reliable contraceptive measures;
- negative serum pregnancy test (if potentially child bearing)
Exclusion Criteria
- Received investigational drugs within 30 days before the start of study treatment or scheduled to receive a highly or moderately emetogenic chemotherapeutic agent;
- Have a clinically unstable seizure disorder with seizure activity requiring anticonvulsant medication;
- Have severe renal or hepatic impairment;
- Have positive serology test results;
- Have a known contraindication to 5-HT3 receptor antagonists;
- Treated with commercially available or investigative palonosetron formulation within 2 weeks prior to start of study treatment;
- Allergic to palonosetron or any other 5-HT3 antagonist;
- Currently a user of any recreational or illicit drugs (including marijuana) or has current evidence of drug or alcohol abuse or dependence as determined by the investigator;
- Will be receiving stem cell rescue therapy in conjunction with study related course of emetogenic chemotherapy;
- Received or will receive total body irradiation or radiation therapy to the abdomen or pelvis in the week prior to Treatment Day 1 and/or during the diary reporting period.
Data sourced from ClinicalTrials.gov (NCT04592198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.