Nausea With Vomiting Chemotherapy-InducedPhase 2NCT04592198
Buccal Film Versus IV Injection Palonosetron for Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting
A Phase 2 study testing Palonosetron Hydrochloride Buccal Film 0.25 Mg, Palonosetron Hydrochloride Buccal Film 0.5 Mg and Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution in people with Nausea With Vomiting Chemotherapy-Induced, run by Xiamen LP Pharmaceutical Co., Ltd at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nausea With Vomiting Chemotherapy-Induced
- What is being tested?
- Palonosetron Hydrochloride Buccal Film 0.25 Mg, Palonosetron Hydrochloride Buccal Film 0.5 Mg and Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Oct 2020to 25 Mar 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Pacific Cancer Medical Center, Inc.
Anaheim, California, 92801
Charleston Oncology
Charleston, South Carolina, 29406
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, 39401
Monongahela Valley Hospital/ Regional Cancer Center
Monongahela, Pennsylvania, 15063
Ocala Oncology Center PL DBA Florida Cancer Affiliates
Ocala, Florida, 34474
Edward H. Kaplan MD & Associates
Skokie, Illinois, 60076
About this study
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
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.
Read the detailed description
This is a Phase 2 study to compare efficacy, safety and PK of palonosetron, a long acting 5-HT3 receptor antagonist, by buccal film compared to iv injection for moderately emetogenic chemotherapy-induced nausea or vomiting (CINV) in cancer patients. Subjects are randomized into three treatment groups, two with the experimental study drug palonosetron in buccal film at one of two different doses or the control treatment using Palonosetron hydrochloride iv injection. Palonosetron PK will be assessed in a subgroup of each treatment group.
- Being tested
- Palonosetron Hydrochloride Buccal Film 0.25 Mg, Palonosetron Hydrochloride Buccal Film 0.5 Mg, Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palonosetron Hydrochloride Buccal Film 0.25 MgDrug
Also called Buccal Film Low Dose
Dose equal to the iv control
Palonosetron Hydrochloride Buccal Film 0.5 MgDrug
Also called Buccal Film High dose
Dose twice that of iv control
Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous SolutionDrug
Also called Control Standard Treatment (Aloxi)
iv control
| Study group | Role | What they receive |
|---|---|---|
| A (Buccal 0.25 Mg) | Experimental | Palonosetron HCl Buccal Film 0.25 Mg Receives: Drug: Palonosetron Hydrochloride Buccal Film 0.25 Mg |
| B (Buccal 0.5 Mg) | Experimental | Palonosetron HCl Buccal Film 0.5 Mg Receives: Drug: Palonosetron Hydrochloride Buccal Film 0.5 Mg |
| C (IV Injection 0.25 Mg) | Active comparator | IV palonosetron 0.25 Mg (ALOXI®) Receives: Drug: Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Acute Response
no emetic episode and no rescue medication during the first 24 hours after chemotherapy
Measured: first 24 hours after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Oct 2020
- Primary completion25 Mar 2021
- Study completion25 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nausea With Vomiting Chemotherapy-InducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiamen LP Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sanjit Nirmalanandhan, Ph.D., Principal investigator, Ocala Oncology Center PL DBA Florida Cancer Affiliates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592198
- Sponsor's protocol ID
- LP-CT-PALO-202002
- Status last verified
- Mar 2025
- First submitted
- 15 Oct 2020
- Last updated
- 24 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04592198
- Acronym / sponsor ID
- LP-CT-PALO-202002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Xiamen LP Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Posted 24 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 2 study to compare efficacy, safety and PK of palonosetron, a long acting 5-HT3 receptor antagonist, by buccal film compared to iv injection for moderately emetogenic chemotherapy-induced nausea or vomiting (CINV) in cancer patients. Subjects are randomized into three treatment groups, two with the experimental study drug palonosetron in buccal film at one of two different doses or the control treatment using Palonosetron hydrochloride iv injection. Palonosetron PK will be assessed in a subgroup of each treatment group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A (Buccal 0.25 Mg) | Experimental | Drug: Palonosetron Hydrochloride Buccal Film 0.25 MgPalonosetron HCl Buccal Film 0.25 Mg |
| B (Buccal 0.5 Mg) | Experimental | Drug: Palonosetron Hydrochloride Buccal Film 0.5 MgPalonosetron HCl Buccal Film 0.5 Mg |
| C (IV Injection 0.25 Mg) | Active comparator | Drug: Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous SolutionIV palonosetron 0.25 Mg (ALOXI®) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palonosetron Hydrochloride Buccal Film 0.25 MgAlso: Buccal Film Low DoseDose equal to the iv control | Drug | A (Buccal 0.25 Mg) |
| Palonosetron Hydrochloride Buccal Film 0.5 MgAlso: Buccal Film High doseDose twice that of iv control | Drug | B (Buccal 0.5 Mg) |
| Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous SolutionAlso: Control Standard Treatment (Aloxi)iv control | Drug | C (IV Injection 0.25 Mg) |
Primary outcome
Complete Acute Response
Time frame: first 24 hours after chemotherapy
no emetic episode and no rescue medication during the first 24 hours after chemotherapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjit Nirmalanandhan, Ph.D. principal investigator
Ocala Oncology Center PL DBA Florida Cancer Affiliates
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palonosetron Hydrochloride Buccal Film 0.25 Mg, Palonosetron Hydrochloride Buccal Film 0.5 Mg and Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution in people with Nausea With Vomiting Chemotherapy-Induced, run by Xiamen LP Pharmaceutical Co., Ltd at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Acute Response (time frame: first 24 hours after chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.