Buccal Film vs IV Palonosetron for Prevention of CINV in Cancer Patients Receiving MEC

Chemotherapy-induced Nausea and Vomiting Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05199818
• Other study ID #: LP-CT-PALO-202101
• Status: Recruiting
• Phase: Phase 3
• Start date: March 1, 2022
• Est. completion date: November 2023

Study information

• Verified date: August 2022
• Source: Xiamen LP Pharmaceutical Co., Ltd
• Contact: Matthew H Nieder, Ph.D.
• Phone: 415 516-9498
• Email: matthew[@]lppharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 328
• Est. completion date: November 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

Drug:
• Palonosetron HCl Buccal Film 0.5 mg
Palonosetron HCl Buccal Film and IV palonosetron placebo, both administered on Day 1
• IV Palonosetron 0.25 mg
IV Palonosetron and Palonosetron HCl Buccal Film placebo, both administered on Day 1

Locations

Country	Name	City	State
United States	Pacific Cancer Medical Center	Anaheim	California
United States	American Oncology Partners of Maryland, PA	Bethesda	Maryland
United States	St. Vincent Frontier Cancer Center	Billings	Montana
United States	Ironwood Cancer & Research Centers	Chandler	Arizona
United States	Gettysburg Cancer Center	Gettysburg	Pennsylvania
United States	Hattiesburg Clinic Hematology/Oncology	Hattiesburg	Mississippi
United States	Watson Clinic	Lakeland	Florida
United States	Tri-County Hematology & Oncology Associates	Massillon	Ohio
United States	Lakes Research	Miami Lakes	Florida
United States	Florida Cancer Affiliates	Ocala	Florida
United States	Summit Cancer Care	Savannah	Georgia
United States	Edward H. Kaplan MD & Associates	Skokie	Illinois
United States	Orchard Healthcare research, Inc.	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 response	No emetic episode and no rescue medication	During the first 24 hours after chemotherapy
Secondary	Complete response	No emetic episode and no rescue medication	24-120 hours post chemotherapy
Secondary	Absence of nausea	Absence of nausea based on daily patient questionnaire (yes or no) and no emetic episode or rescue medication	up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy
Secondary	Complete response	The proportion of patients with complete response	up to 120 hours after chemotherapy
Secondary	Complete control	The proportion of patients with complete control	up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy
Secondary	Number of emetic episodes	Number of emetic episodes	up to 120 hours after chemotherapy