Trial | NCT04592198  Report issue

Title

Buccal Film Versus IV Injection Palonosetron for Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting
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 (ALOXI®) for the Prevention of Chemotherapy-induced Nausea and

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    22
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.
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 Started
Oct 01
2020
Primary Completion
Mar 26
2021
Study Completion
Mar 26
2021
Last Update
May 14
2021

Drug Palonosetron Hydrochloride Buccal Film 0.25 Mg

Dose equal to the iv control

  • Other names: Buccal Film Low Dose

Drug Palonosetron Hydrochloride Buccal Film 0.5 Mg

Dose twice that of iv control

  • Other names: Buccal Film High dose

Drug Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution

iv control

  • Other names: Control Standard Treatment (Aloxi)

A (Buccal 0.25 Mg) Experimental

Palonosetron HCl Buccal Film 0.25 Mg and oral dexamethasone 12 Mg, both administered on Day 1, and dexamethasone 8 Mg PO on days 2 and 3

B (Buccal 0.5 Mg) Experimental

Palonosetron HCl Buccal Film 0.5 Mg and oral dexamethasone 12 Mg, both administered on Day 1, and dexamethasone 8 Mg PO on days 2 and 3

C (IV Injection 0.25 Mg) Active Comparator

IV palonosetron 0.25 Mg (ALOXI®) and oral dexamethasone 12 Mg, both administered on Day 1, and dexamethasone 8 Mg PO on days 2 and 3

Criteria 

Inclusion Criteria:

With histologically or cytologically confirmed malignant disease;

Karnofsky index ≥ 50;
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)
Be able to read, understand, and follow the study procedures and able to complete patient diary autonomously.

Exclusion Criteria:

Expect to be non-compliant with the study procedures;
Received investigational drugs within 30 days before the start of study treatment or scheduled to receive a highly or moderately emetogenic chemotherapeutic agent during Day 2 to 6 of the study;
Has any condition that could have been associated with a risk of emesis near or at the time of study drug administration;
Have a clinically unstable seizure disorder with seizure activity requiring anticonvulsant medication;
Experienced any vomiting, retching, or National Cancer Institute (NCI) Common Toxicity Criteria grade 2 or 3 or nausea within 24 hours preceding chemotherapy;
Have ongoing nausea or vomiting from any organic etiology;
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.
Had non-chronic benzodiazepine, opioid or opioid like (e.g., tramadol hydrochloride) therapy initiated within 48 hours prior to study drug administration or is expected to receive within 120 hours following initiation of chemotherapy, except for single daily doses of midazolam, temazepam or triazolam.
Started on systemic corticosteroid therapy within 72 hours prior to study drug administration or is expected to receive a corticosteroid as part of chemotherapy regimen.
No Results Posted