drugset / Trial / NCT07482891
An Exploratory Study on Efficacy and Safety of Fosaprepitant and Palonosetron Hydrochloride for Injection in Preventing CINV From Multi-Agent HEC
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This prospective, multicenter, non-comparative, open-label trial design aims to evaluate the efficacy and safety of Fosrolapitant and Palonosetron Hydrochloride for Injection in preventing nausea and vomiting induced by hyperemetic chemotherapy (HEC) over multiple days. Eligible subjects were screened and assigned to Arm 1 or Arm 2 according to medical protocol. Arm 1: Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone + Olanzapine; Arm 2: Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone. Study drug administration commenced within 48 hours post-randomization, with follow-up visits and examinations completed as per protocol.
Timeline
- Start
- 2026-03-10
- Primary completion
- 2026-10-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fosrolapitant | Small molecule | — | Intravenous |
| Subject | Olanzapine | Small molecule | 5 mg | Oral |
| Subject | Palonosetron | Other / unclassified | — | Intravenous |
| Background | Dexamethasone | Small molecule | 3.75 mg | Oral |