Clinical trial · Interventional
Buccal Film Versus IV Injection Palonosetron for Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting
A Randomized, Dose-ranging, Open-label, Parallel Group Study to Assess the Efficacy, Safety and Pharmacokinetics of Palonosetron HCl Buccal Film Versus IV Palonosetron 0.25 mg for the Prevention of CINV in Cancer Patients Receiving MEC
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nausea With Vomiting Chemotherapy-Induced | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution | Drug | — | UNRESOLVED |
| Palonosetron Hydrochloride Buccal Film 0.25 Mg | Drug | — | UNRESOLVED |
| Palonosetron Hydrochloride Buccal Film 0.5 Mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- A (Buccal 0.25 Mg)
- description
- Palonosetron HCl Buccal Film 0.25 Mg
- interventionNames
- Drug: Palonosetron Hydrochloride Buccal Film 0.25 Mg
- type
- EXPERIMENTAL
- label
- B (Buccal 0.5 Mg)
- description
- Palonosetron HCl Buccal Film 0.5 Mg
- interventionNames
- Drug: Palonosetron Hydrochloride Buccal Film 0.5 Mg
- type
- ACTIVE_COMPARATOR
- label
- C (IV Injection 0.25 Mg)
- description
- IV palonosetron 0.25 Mg (ALOXI®)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available