Buccal Film Versus IV Injection Palonosetron for Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-03-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nausea With Vomiting Chemotherapy-Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A (Buccal 0.25 Mg)

Palonosetron HCl Buccal Film 0.25 Mg

Group Type EXPERIMENTAL

Palonosetron Hydrochloride Buccal Film 0.25 Mg

Intervention Type DRUG

Dose equal to the iv control

B (Buccal 0.5 Mg)

Palonosetron HCl Buccal Film 0.5 Mg

Group Type EXPERIMENTAL

Palonosetron Hydrochloride Buccal Film 0.5 Mg

Intervention Type DRUG

Dose twice that of iv control

C (IV Injection 0.25 Mg)

IV palonosetron 0.25 Mg (ALOXI®)

Group Type ACTIVE_COMPARATOR

Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution

Intervention Type DRUG

iv control

Interventions

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Palonosetron Hydrochloride Buccal Film 0.25 Mg

Dose equal to the iv control

Intervention Type DRUG

Palonosetron Hydrochloride Buccal Film 0.5 Mg

Dose twice that of iv control

Intervention Type DRUG

Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution

iv control

Intervention Type DRUG

Other Intervention Names

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Buccal Film Low Dose Buccal Film High dose Control Standard Treatment (Aloxi)

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No