Back to resultsBuccal Film vs IV Palonosetron for Prevention of CINV in Cancer Patients Receiving MEC
Primary Purpose
Chemotherapy-induced Nausea and Vomiting
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Palonosetron HCl Buccal Film 0.5 mg
IV Palonosetron 0.25 mg
Sponsored by
About this trial
This is an interventional prevention trial for Chemotherapy-induced Nausea and Vomiting
Eligibility Criteria
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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；
- 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.
Sites / Locations
- Ironwood Cancer & Research CentersRecruiting
- Pacific Cancer Medical CenterRecruiting
- Watson ClinicRecruiting
- Lakes ResearchRecruiting
- Florida Cancer AffiliatesRecruiting
- Summit Cancer CareRecruiting
- Edward H. Kaplan MD & AssociatesRecruiting
- Orchard Healthcare research, Inc.Recruiting
- American Oncology Partners of Maryland, PARecruiting
- Hattiesburg Clinic Hematology/OncologyRecruiting
- St. Vincent Frontier Cancer CenterRecruiting
- Tri-County Hematology & Oncology AssociatesRecruiting
- Gettysburg Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Palonosetron HCl Buccal Film
Palonosetron IV Injection
Arm 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
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
Outcomes
Primary Outcome Measures
Complete response
No emetic episode and no rescue medication
Secondary Outcome Measures
Complete response
No emetic episode and no rescue medication
Absence of nausea
Absence of nausea based on daily patient questionnaire (yes or no) and no emetic episode or rescue medication
Complete response
The proportion of patients with complete response
Complete control
The proportion of patients with complete control
Number of emetic episodes
Number of emetic episodes
Full Information
NCT ID
NCT05199818
First Posted
December 15, 2021
Last Updated
January 19, 2023
Sponsor
Xiamen LP Pharmaceutical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05199818
Brief Title
Buccal Film vs IV Palonosetron for Prevention of CINV in Cancer Patients Receiving MEC
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiamen LP Pharmaceutical Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Nausea and Vomiting
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
328 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Palonosetron HCl Buccal Film
Arm Type
Experimental
Arm 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
Arm Title
Palonosetron IV Injection
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Palonosetron HCl Buccal Film 0.5 mg
Intervention Description
Palonosetron HCl Buccal Film and IV palonosetron placebo, both administered on Day 1
Intervention Type
Drug
Intervention Name(s)
IV Palonosetron 0.25 mg
Intervention Description
IV Palonosetron and Palonosetron HCl Buccal Film placebo, both administered on Day 1
Primary Outcome Measure Information:
Title
Complete response
Description
No emetic episode and no rescue medication
Time Frame
During the first 24 hours after chemotherapy
Secondary Outcome Measure Information:
Title
Complete response
Description
No emetic episode and no rescue medication
Time Frame
24-120 hours post chemotherapy
Title
Absence of nausea
Description
Absence of nausea based on daily patient questionnaire (yes or no) and no emetic episode or rescue medication
Time Frame
up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy
Title
Complete response
Description
The proportion of patients with complete response
Time Frame
up to 120 hours after chemotherapy
Title
Complete control
Description
The proportion of patients with complete control
Time Frame
up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy
Title
Number of emetic episodes
Description
Number of emetic episodes
Time Frame
up to 120 hours after chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
Exclusion Criteria:
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；
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew H Nieder, Ph.D.
Phone
415 516-9498
Email
matthew@lppharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Linhui Cai, MS
Phone
+86 173-5003-2816
Email
clh@lppharma.com
Facility Information:
Facility Name
Ironwood Cancer & Research Centers
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikhail Shtivelband, MD
Phone
480-821-2838
Email
barbara.ramirez@ironwood.com
Facility Name
Pacific Cancer Medical Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ajit Maniam, Dr
Facility Name
Watson Clinic
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shalini Mulaparthi, MD
Phone
863-904-2482
Facility Name
Lakes Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eloy Roman, MD
Facility Name
Florida Cancer Affiliates
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anju Vasudevan, MD
Phone
352-732-4032
Facility Name
Summit Cancer Care
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Taylor, MD
Phone
912-651-5771
Facility Name
Edward H. Kaplan MD & Associates
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward H Kaplan, MD
Facility Name
Orchard Healthcare research, Inc.
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ira Oliff, MD
Phone
224-534-7580
Email
jardinico@orchardhr.com
Facility Name
American Oncology Partners of Maryland, PA
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralph Boccia, MD
Phone
240-482-0526
Facility Name
Hattiesburg Clinic Hematology/Oncology
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Hrom, MD
Phone
601-261-1700
Email
gloria.simmons@forrestgeneral.com
Facility Name
St. Vincent Frontier Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Cobb, MD
Phone
406-238-6290
Email
erin.juedeman@sclhealth.org
Facility Name
Tri-County Hematology & Oncology Associates
City
Massillon
State/Province
Ohio
ZIP/Postal Code
44646
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott McGee, MD
Phone
330-489-8118
Facility Name
Gettysburg Cancer Center
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17325
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Satish A Shah, MD
Phone
717-334-4033
12. IPD Sharing Statement
Plan to Share IPD
No
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Buccal Film vs IV Palonosetron for Prevention of CINV in Cancer Patients Receiving MEC
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