Clinical trial · Interventional
Buccal Film vs IV Palonosetron for Prevention of CINV in Cancer Patients Receiving MEC
Efficacy and Safety of Palonosetron HCl Buccal Film Versus IV Palonosetron for Prevention of Chemotherapy-induced Nausea and Vomiting in Cancer Patients Receiving Moderately Emetogenic Chemotherapy
- 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)
The phase 3 study is to compare the efficacy and safety of palonosetron, a long-acting 5-HT3 receptor antagonist, by buccal film delivery compared to IV injection for the prevention of chemotherapy-induced nausea and vomiting. 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 |
|---|---|---|---|
| Chemotherapy-induced Nausea and Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IV Palonosetron 0.25 mg | Drug | — | UNRESOLVED |
| Palonosetron HCl Buccal Film 0.5 mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Palonosetron HCl Buccal Film
- description
- Palonosetron HCl Buccal Film 0.5 mg 1 hr before administration of moderately emetogenic chemotherapy and normal saline injection 30 minutes before administration of moderately emetogenic chemotherapy
- interventionNames
- Drug: Palonosetron HCl Buccal Film 0.5 mg
- type
- ACTIVE_COMPARATOR
- label
- Palonosetron IV Injection
- description
- Placebo buccal film 1 har before administration of moderately emetogenic chemotherapy and Palonosetron HCl Injection 0.25 mg 30 min before administration of moderately emetogenic chemotherapy
- interventionNames
- Drug: IV Palonosetron 0.25 mg
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female, at least 18-years of age; 2. Provide written informed consent; 3. Chemotherapy naïve subject with histologically or cytologically confirmed malignant disease; or chemotherapy non-naïve subject with histologically proven diagnosis of cancer; 4. Karnofsky index ≥ 50; 5. Be scheduled to receive MEC to be administered on Day 1; Exclusion Criteria: 1. Unable to understand or cooperate with study procedure； 2. Received any investigational drug 30 days prior to study entry； 3. Used any drug with anti-emetic efficacy 24 hours prior to treatment and during the study； 4. Enrollment in a previous study with palonosetron； 5. Seizure disorder requiring anticonvulsant medication; 6. Experienced any vomiting, retching, or NCI Common Toxicity Criteria grade 2 or 3 nausea in the 24 hours preceding chemotherapy； 7. Ongoing vomiting from any organic etiology； 8. Experienced nausea (moderate to severe or vomiting following any previous chemotherapy)； 9. Scheduled to receive moderately or highly-emetogenic chemotherapy or radiotherapy during the study； 10. Known contraindication to 5-HT3 antagonist or dexamethasone； 11. Scheduled to receive bone marrow or stem cell transplant during study; 12. Symptomatic primary or metastatic CNS malignancy; 13. Lactating female.
References
Publications (0)
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