Buccal Film vs IV Palonosetron for Prevention of CINV in Cancer Patients Receiving MEC
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- STATUS
- Recruiting
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- End date
- Dec 9, 2022
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- participants needed
- 328
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- sponsor
- Xiamen LP Pharmaceutical Co., Ltd
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).
Details
| Condition | Chemotherapy-induced Nausea and Vomiting |
|---|---|
| Treatment | Palonosetron HCl Buccal Film 0.5 mg, IV Palonosetron 0.25 mg |
| Clinical Study Identifier | NCT05199818 |
| Sponsor | Xiamen LP Pharmaceutical Co., Ltd |
| Last Modified on | 9 June 2022 |
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