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

Nausea With Vomiting Chemotherapy-Induced Clinical Trial

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 (ALOXI®) for the Prevention of Chemotherapy-induced Nausea and

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04592198
• Other study ID #: LP-CT-PALO-202002
• Status: Completed
• Phase: Phase 2
• Start date: October 1, 2020
• Est. completion date: March 26, 2021

Study information

• Verified date: May 2021
• Source: Xiamen LP Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 26, 2021
• Est. primary completion date: March 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nausea
• Nausea With Vomiting Chemotherapy-Induced
• Vomiting

Intervention

Drug:
• Palonosetron Hydrochloride Buccal Film 0.25 Mg
Dose equal to the iv control
• Palonosetron Hydrochloride Buccal Film 0.5 Mg
Dose twice that of iv control
• Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution
iv control

Locations

Country	Name	City	State
United States	Pacific Cancer Medical Center, Inc.	Anaheim	California
United States	Charleston Oncology	Charleston	South Carolina
United States	Gettysburg Cancer Center	Gettysburg	Pennsylvania
United States	Hattiesburg Clinic Hematology/Oncology	Hattiesburg	Mississippi
United States	Monongahela Valley Hospital/ Regional Cancer Center	Monongahela	Pennsylvania
United States	Ocala Oncology Center PL DBA Florida Cancer Affiliates	Ocala	Florida
United States	Edward H. Kaplan MD & Associates	Skokie	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Xiamen LP Pharmaceutical Co., Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete acute response	no emetic episode and no rescue medication	during the first 24 hours after chemotherapy
Secondary	Complete delayed response	no emetic episode and no rescue medication	24-120 hours post chemotherapy
Secondary	Complete response	no emetic episode and no rescue medication	up to 120 hours post chemotherapy
Secondary	No nausea	visual analog scale (0-100 mm, 0=no, 100=severe) < 5 mm	up to 120 hours post chemotherapy
Secondary	No significant nausea	visual analog scale (0-100 mm, 0=no, 100=severe) < 25 mm	up to 120 hours post chemotherapy
Secondary	Complete protection	no emesis, no rescue therapy, no significant nausea (questionnaire)	up to 120 hours post chemotherapy
Secondary	Number of emetic episodes	Number of emetic episodes	up to 120 hours post chemotherapy
Secondary	Time to rescue medication	Time to rescue medication	up to 120 hours post chemotherapy
Secondary	Time to treatment failure	time to first emetic episode or administration of rescue therapy, whichever occurred first	up to 120 hours post chemotherapy
Secondary	Severity of nausea	Rhodes Index of Nausea, Vomiting and Retching (0-4, 0=no nausea, 4=severe nausea)	up to 120 hours post chemotherapy
Secondary	Subject global satisfaction with therapy	visual analog scale (0-100mm, 0=not at all satisfied, 100=totally satisfied)	up to 120 hours post chemotherapy
Secondary	Quality of life questionnaire	Functional Living Index-Emesis	up to 120 hours post chemotherapy