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

• Status: Not yet recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiamen LP Pharmaceutical Co., Ltd
• Treatments: Palonosetron

Criteria

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. Lactating female.