Clinical trial NCT05199818: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chemotherapy-induced Nausea and Vomiting
Lead sponsor: Xiamen LP Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-01-20
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: Inclusion Criteria:

1. Male or female, at least 18-years of age;
2. Provide written informed consent;
3. Chemotherapy naïve subject with histologically or cytologically confirmed malignant disease; or chemotherapy non-naïve subject with histologically proven diagnosis of cancer;
4. Karnofsky index ≥ 50;
5. Be scheduled to receive MEC to be administered on Day 1;

Exclusion Criteria:

1. Unable to understand or cooperate with study procedure；
2. Received any investigational drug 30 days prior to study entry；
3. Used any drug with anti-emetic efficacy 24 hours prior to treatment and during the study；
4. Enrollment in a previous study with palonosetron；
5. Seizure disorder requiring anticonvulsant medication;
6. Experienced any vomiting, retching, or NCI Common Toxicity Criteria grade 2 or 3 nausea in the 24 hours preceding chemotherapy；
7. Ongoing vomiting from any organic etiology；
8. Experienced nausea (moderate to severe or vomiting following any previous chemotherapy)；
9. Scheduled to receive moderately or highly-emetogenic chemotherapy or radiotherapy during the study；
10. Known contraindication to 5-HT3 antagonist or dexamethasone；
11. Scheduled to receive bone marrow or stem cell transplant during study;
12. Symptomatic primary or metastatic CNS malignancy;
13. Lactating female.

Primary outcomes:
measure: Complete response
timeFrame: During the first 24 hours after chemotherapy
Secondary outcomes:
measure: Complete response
timeFrame: 24-120 hours post chemotherapy
measure: Absence of nausea
timeFrame: up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy
measure: Complete response
timeFrame: up to 120 hours after chemotherapy
measure: Complete control
timeFrame: up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy
measure: Number of emetic episodes
timeFrame: up to 120 hours after chemotherapy
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer & Research Centers
state: Arizona
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center
state: California
city: Lakeland
country: United States
facility: Watson Clinic
state: Florida
city: Miami Lakes
country: United States
facility: Lakes Research
state: Florida
city: Ocala
country: United States
facility: Florida Cancer Affiliates
state: Florida
city: Savannah
country: United States
facility: Summit Cancer Care
state: Georgia
city: Skokie
country: United States
facility: Edward H. Kaplan MD & Associates
state: Illinois
city: Skokie
country: United States
facility: Orchard Healthcare research, Inc.
state: Illinois
city: Bethesda
country: United States
facility: American Oncology Partners of Maryland, PA
state: Maryland
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic Hematology/Oncology
state: Mississippi
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center
state: Montana
city: Massillon
country: United States
facility: Tri-County Hematology & Oncology Associates
state: Ohio
city: Gettysburg
country: United States
facility: Gettysburg Cancer Center
state: Pennsylvania
Study officials:
References: