Clinical trial NCT04592198: Buccal Film Versus IV Injection Palonosetron for Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nausea With Vomiting Chemotherapy-Induced
Lead sponsor: Xiamen LP Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2020-10-19
Enrollment: 22
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: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: Complete Acute Response
timeFrame: first 24 hours after chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center, Inc.
state: California
city: Ocala
country: United States
facility: Ocala Oncology Center PL DBA Florida Cancer Affiliates
state: Florida
city: Skokie
country: United States
facility: Edward H. Kaplan MD & Associates
state: Illinois
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic Hematology/Oncology
state: Mississippi
city: Gettysburg
country: United States
facility: Gettysburg Cancer Center
state: Pennsylvania
city: Monongahela
country: United States
facility: Monongahela Valley Hospital/ Regional Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Oncology
state: South Carolina
Study officials:
affiliation: Ocala Oncology Center PL DBA Florida Cancer Affiliates
name: Sanjit Nirmalanandhan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: