drugset / Trial / NCT07841210
Fosrolapitant and Palonosetron for Highly Emetogenic ADC-Induced Nausea and Vomiting in Solid Tumors
Phase 2
Active not recruiting
60 enrolled
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hubei Cancer Hospital · collabNanyang Central Hospital · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
This study aims to evaluate the efficacy and safety of Fosrolapitant and Palonosetron Hydrochloride for Injection in preventing nausea and vomiting induced by highly emetogenic antibody-drug conjugate (ADC) therapy in patients with solid tumors. A total of 60 patients are planned to be enrolled and divided into two groups: Group A will receive Fosrolapitant and Palonosetron Hydrochloride for Injection plus Dexamethasone plus Olanzapine, and Group B will receive Fosrolapitant and Palonosetron Hydrochloride for Injection plus Dexamethasone.
Timeline
- Start
- 2026-09-14
- Primary completion
- 2028-01-31
- Completion
- 2028-01-31
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 |
Indications
No indication recorded.