Buccal Film Versus IV Injection Palonosetron for Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting
Completed · Phase 2
Conditions studied: Nausea With Vomiting Chemotherapy-Induced
In brief
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.
Key facts
- Study ID
- NCT04592198
- Run by
- Xiamen LP Pharmaceutical Co., Ltd
- People needed
- 22
- Starts
- 2020-10-01
- Expected to finish
- 2021-03-25
- Last updated by the study team
- 2025-03-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- Pacific Cancer Medical Center, Inc. — Anaheim, California, United States
- Ocala Oncology Center PL DBA Florida Cancer Affiliates — Ocala, Florida, United States
- Edward H. Kaplan MD & Associates — Skokie, Illinois, United States
- Hattiesburg Clinic Hematology/Oncology — Hattiesburg, Mississippi, United States
- Gettysburg Cancer Center — Gettysburg, Pennsylvania, United States
- Monongahela Valley Hospital/ Regional Cancer Center — Monongahela, Pennsylvania, United States
- Charleston Oncology — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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