Chemotherapy-induced Nausea and VomitingPhase 3NCT05199818
Buccal Film vs IV Palonosetron for Prevention of CINV in Cancer Patients Receiving MEC
A Phase 3 study testing Palonosetron HCl Buccal Film 0.5 mg and IV Palonosetron 0.25 mg in people with Chemotherapy-induced Nausea and Vomiting, run by Xiamen LP Pharmaceutical Co., Ltd at 13 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- Palonosetron HCl Buccal Film 0.5 mg and IV Palonosetron 0.25 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 13 sitesUnited States
- Study dates
- 1 Mar 2022to Nov 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Male or female, at least 18-years of age;
- Provide written informed consent;
- Chemotherapy naïve subject with histologically or cytologically confirmed malignant disease; or chemotherapy non-naïve subject with histologically proven diagnosis of cancer;
- Karnofsky index ≥ 50;
- Be scheduled to receive MEC to be administered on Day 1;
Who cannot join
- Unable to understand or cooperate with study procedure；
- Received any investigational drug 30 days prior to study entry；
- Used any drug with anti-emetic efficacy 24 hours prior to treatment and during the study；
- Enrollment in a previous study with palonosetron；
- Seizure disorder requiring anticonvulsant medication;
- Experienced any vomiting, retching, or NCI Common Toxicity Criteria grade 2 or 3 nausea in the 24 hours preceding chemotherapy；
Show all 13Show fewer
- Ongoing vomiting from any organic etiology；
- Experienced nausea (moderate to severe or vomiting following any previous chemotherapy)；
- Scheduled to receive moderately or highly-emetogenic chemotherapy or radiotherapy during the study；
- Known contraindication to 5-HT3 antagonist or dexamethasone；
- Scheduled to receive bone marrow or stem cell transplant during study;
- Symptomatic primary or metastatic CNS malignancy;
- Lactating female.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
Pacific Cancer Medical Center
Anaheim, California, 92801
Ajit Maniam, Dr
- Recruiting
American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817
Ralph Boccia, MD, 240-482-0526
- Recruiting
St. Vincent Frontier Cancer Center
Billings, Montana, 59102
Patrick Cobb, MD, 406-238-6290, erin.juedeman@sclhealth.org
- Recruiting
Ironwood Cancer & Research Centers
Chandler, Arizona, 85224
Mikhail Shtivelband, MD, 480-821-2838, barbara.ramirez@ironwood.com
- Recruiting
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325
Satish A Shah, MD, 717-334-4033
- Recruiting
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, 39401
John Hrom, MD, 601-261-1700, gloria.simmons@forrestgeneral.com
- Recruiting
Watson Clinic
Lakeland, Florida, 33805
Shalini Mulaparthi, MD, 863-904-2482
- Recruiting
Tri-County Hematology & Oncology Associates
Massillon, Ohio, 44646
Scott McGee, MD, 330-489-8118
- Recruiting
Lakes Research
Miami Lakes, Florida, 33014
Eloy Roman, MD
- Recruiting
Florida Cancer Affiliates
Ocala, Florida, 34474
Anju Vasudevan, MD, 352-732-4032
- Recruiting
Summit Cancer Care
Savannah, Georgia, 31405
Mark Taylor, MD, 912-651-5771
- Recruiting
Edward H. Kaplan MD & Associates
Skokie, Illinois, 60076
Edward H Kaplan, MD
- Recruiting
Orchard Healthcare research, Inc.
Skokie, Illinois, 60077
Ira Oliff, MD, 224-534-7580, jardinico@orchardhr.com
About this study
Official title: 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
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.
Read the detailed description
This is a phase 3 randomized, double-blind, parallel group study designed to evaluate the efficacy and safety of palonosetron HCL buccal film versus IV palonosetron for the prevention of chemotherapy-induced nausea and vomiting in cancer patients receiving moderately emetogenic chemotherapy (MEC).
Subjects are randomized into two treatment groups, one with the experimental study drug palonosetron in buccal film, the other one with the control treatment using Palonosetron hydrochloride IV injection. Palonosetron PK will be assessed in a subgroup of each treatment group (two sample points, 10% of subjects).
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- Palonosetron HCl Buccal Film 0.5 mg, IV Palonosetron 0.25 mg
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palonosetron HCl Buccal Film 0.5 mgDrug
Palonosetron HCl Buccal Film and IV palonosetron placebo, both administered on Day 1
IV Palonosetron 0.25 mgDrug
IV Palonosetron and Palonosetron HCl Buccal Film placebo, both administered on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Palonosetron HCl Buccal Film | Experimental | 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 Receives: Drug: Palonosetron HCl Buccal Film 0.5 mg |
| Palonosetron IV Injection | Active comparator | 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 Receives: Drug: IV Palonosetron 0.25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response
No emetic episode and no rescue medication
Measured: During the first 24 hours after chemotherapy
Secondary outcomes (5)
Complete response
No emetic episode and no rescue medication
Measured: 24-120 hours post chemotherapy
Absence of nausea
Absence of nausea based on daily patient questionnaire (yes or no) and no emetic episode or rescue medication
Measured: up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy
Complete response
The proportion of patients with complete response
Measured: up to 120 hours after chemotherapy
Complete control
The proportion of patients with complete control
Measured: up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy
Number of emetic episodes
Number of emetic episodes
Measured: up to 120 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 posted20 Jan 2022
- Study start1 Mar 2022
- Primary completionSep 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Nausea and VomitingStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiamen LP Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199818
- Sponsor's protocol ID
- LP-CT-PALO-202101
- Status last verified
- Aug 2022
- First submitted
- 15 Dec 2021
- Last updated
- 20 Jan 2023
- Results posted
- 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 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05199818
- Acronym / sponsor ID
- LP-CT-PALO-202101
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- Xiamen LP Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase 3 randomized, double-blind, parallel group study designed to evaluate the efficacy and safety of palonosetron HCL buccal film versus IV palonosetron for the prevention of chemotherapy-induced nausea and vomiting in cancer patients receiving moderately emetogenic chemotherapy (MEC).
Subjects are randomized into two treatment groups, one with the experimental study drug palonosetron in buccal film, the other one with the control treatment using Palonosetron hydrochloride IV injection. Palonosetron PK will be assessed in a subgroup of each treatment group (two sample points, 10% of subjects).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palonosetron HCl Buccal Film | Experimental | Drug: Palonosetron HCl Buccal Film 0.5 mgPalonosetron 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 |
| Palonosetron IV Injection | Active comparator | Drug: IV Palonosetron 0.25 mgPlacebo 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, at least 18-years of age;
- Provide written informed consent;
- Chemotherapy naïve subject with histologically or cytologically confirmed malignant disease; or chemotherapy non-naïve subject with histologically proven diagnosis of cancer;
- Karnofsky index ≥ 50;
- Be scheduled to receive MEC to be administered on Day 1;
Key exclusion criteria (13 listed)
- Unable to understand or cooperate with study procedure；
- Received any investigational drug 30 days prior to study entry；
- Used any drug with anti-emetic efficacy 24 hours prior to treatment and during the study；
- Enrollment in a previous study with palonosetron；
- Seizure disorder requiring anticonvulsant medication;
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 HCl Buccal Film 0.5 mgPalonosetron HCl Buccal Film and IV palonosetron placebo, both administered on Day 1 | Drug | Palonosetron HCl Buccal Film |
| IV Palonosetron 0.25 mgIV Palonosetron and Palonosetron HCl Buccal Film placebo, both administered on Day 1 | Drug | Palonosetron IV Injection |
Primary outcome
Complete response
Time frame: During the first 24 hours after chemotherapy
No emetic episode and no rescue medication
5 secondary outcomes
Complete response
Time frame: 24-120 hours post chemotherapy
Absence of nausea
Time frame: up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy
Complete response
Time frame: up to 120 hours after chemotherapy
Complete control
Time frame: up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy
Number of emetic episodes
Time frame: up to 120 hours after chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- 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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Palonosetron HCl Buccal Film 0.5 mg and IV Palonosetron 0.25 mg in people with Chemotherapy-induced Nausea and Vomiting, run by Xiamen LP Pharmaceutical Co., Ltd at 13 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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew H Nieder, Ph.D. (415 516-9498, matthew@lppharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response (time frame: During the 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 20 Jan 2023.