Buccal Film Versus IV Injection Palonosetron for Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting
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Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT04592198
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 22 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 1, 2020 (Actual)
- Primary completion
- Mar 25, 2021 (Actual)
- Completion
- Mar 25, 2021 (Actual)
- Last update posted
- Mar 24, 2025
2020 – 2021
United States locations
- U.S. sites
- 7
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pacific Cancer Medical Center, Inc. | Anaheim | California | 92801 | — |
| Ocala Oncology Center PL DBA Florida Cancer Affiliates | Ocala | Florida | 34474 | — |
| Edward H. Kaplan MD & Associates | Skokie | Illinois | 60076 | — |
| Hattiesburg Clinic Hematology/Oncology | Hattiesburg | Mississippi | 39401 | — |
| Gettysburg Cancer Center | Gettysburg | Pennsylvania | 17325 | — |
| Monongahela Valley Hospital/ Regional Cancer Center | Monongahela | Pennsylvania | 15063 | — |
| Charleston Oncology | Charleston | South Carolina | 29406 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04592198, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 24, 2025 · Synced Nov 15, 2026
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