Status:
UNKNOWN
Buccal Film vs IV Palonosetron for Prevention of CINV in Cancer Patients Receiving MEC
Lead Sponsor:
Xiamen LP Pharmaceutical Co., Ltd
Conditions:
Chemotherapy-induced Nausea and Vomiting
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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-in...
Detailed 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-...
Eligibility Criteria
Inclusion
- Male or female, at least 18-years of age;
- Provide written informed consent;
- Chemotherapy naïve subject with histologically or cytologically confirmed malignant disease; or chemotherapy non-naïve subject with histologically proven diagnosis of cancer;
- Karnofsky index ≥ 50;
- Be scheduled to receive MEC to be administered on Day 1;
Exclusion
- Unable to understand or cooperate with study procedure；
- Received any investigational drug 30 days prior to study entry；
- Used any drug with anti-emetic efficacy 24 hours prior to treatment and during the study；
- Enrollment in a previous study with palonosetron；
- Seizure disorder requiring anticonvulsant medication;
- Experienced any vomiting, retching, or NCI Common Toxicity Criteria grade 2 or 3 nausea in the 24 hours preceding chemotherapy；
- Ongoing vomiting from any organic etiology；
- Experienced nausea (moderate to severe or vomiting following any previous chemotherapy)；
- Scheduled to receive moderately or highly-emetogenic chemotherapy or radiotherapy during the study；
- Known contraindication to 5-HT3 antagonist or dexamethasone；
- Scheduled to receive bone marrow or stem cell transplant during study;
- Symptomatic primary or metastatic CNS malignancy;
- Lactating female.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT05199818
Start Date
March 1 2022
End Date
November 1 2023
Last Update
January 20 2023
Active Locations (13)
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1
Ironwood Cancer & Research Centers
Chandler, Arizona, United States, 85224
2
Pacific Cancer Medical Center
Anaheim, California, United States, 92801
3
Watson Clinic
Lakeland, Florida, United States, 33805
4
Lakes Research
Miami Lakes, Florida, United States, 33014