At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 22 enrolled
Drug / intervention
Palonosetron Hydrochloride Buccal Film 0.25 Mg +2 moredrug
Likely dose
Palonosetron Hydrochloride Buccal Film 0.25 Mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Palonosetron Hydrochloride Buccal Film 0.25 Mg, Palonosetron Hydrochloride Buccal Film 0.5 Mg, and 1 other intervention for Nausea With Vomiting Chemotherapy-Induced. Completed, enrolled 22 participants across 7 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
Enrollment StartOct 2020
First PostedOct 2020
Primary CompletionMar 2021
TodayJul 2026
First PostedOct 19, 2020
Enrollment StartOct 1, 2020
Primary CompletionMar 25, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.7 years ago
Interventions
Palonosetron Hydrochloride Buccal Film 0.25 Mgdrug
Dose equal to the iv control
Palonosetron Hydrochloride Buccal Film 0.5 Mgdrug
Dose twice that of iv control
Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solutiondrug
iv control