Buccal Film vs IV Palonosetron for Prevention of CINV in Cancer Patients Receiving MEC
Status unconfirmed · Phase 3 · Has a placebo group
Conditions studied: Chemotherapy-induced Nausea and Vomiting
In brief
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.
Key facts
- Study ID
- NCT05199818
- Run by
- Xiamen LP Pharmaceutical Co., Ltd
- People needed
- 328
- Starts
- 2022-03-01
- Expected to finish
- 2023-11-01
- Last updated by the study team
- 2023-01-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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.
Where it is running
- Ironwood Cancer & Research Centers — Chandler, Arizona, United States (enrolling)
- Pacific Cancer Medical Center — Anaheim, California, United States (enrolling)
- Watson Clinic — Lakeland, Florida, United States (enrolling)
- Lakes Research — Miami Lakes, Florida, United States (enrolling)
- Florida Cancer Affiliates — Ocala, Florida, United States (enrolling)
- Summit Cancer Care — Savannah, Georgia, United States (enrolling)
- Edward H. Kaplan MD & Associates — Skokie, Illinois, United States (enrolling)
- Orchard Healthcare research, Inc. — Skokie, Illinois, United States (enrolling)
- American Oncology Partners of Maryland, PA — Bethesda, Maryland, United States (enrolling)
- Hattiesburg Clinic Hematology/Oncology — Hattiesburg, Mississippi, United States (enrolling)
- St. Vincent Frontier Cancer Center — Billings, Montana, United States (enrolling)
- Tri-County Hematology & Oncology Associates — Massillon, Ohio, United States (enrolling)
- Gettysburg Cancer Center — Gettysburg, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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