drugset / Trial / NCT01376297
A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting
RandomizedParallel-groupQuadruple-blindPrevention
Summary
NETU-10-29 is a clinical study assessing safety of netupitant and palonosetron, two antiemetic drugs, both given with oral dexamethasone. The objective of the study is to evaluate if netupitant and palonosetron are safe when administered to prevent nausea and vomiting after administration of repeated cycles of chemotherapy.
Timeline
- Start
- 2011-07
- Primary completion
- 2012-09
- Completion
- —
Publications
- Schwartzberg L, Karthaus M, Rossi G, Rizzi G, Borroni ME, Rugo HS, Jordan K, Hansen V. Fixed combination of oral NEPA (netupitant-palonosetron) for the prevention of acute and delayed chemotherapy-induced nausea and vomiting in patients receiving multiple cycles of chemotherapy: Efficacy data from 2 randomized, double-blind phase III studies. Cancer Med. 2019 May;8(5):2064-2073. doi: 10.1002/cam4.2091. Epub 2019 Apr 9.
- Rugo HS, Rossi G, Rizzi G, Aapro M. Efficacy of NEPA (netupitant/palonosetron) across multiple cycles of chemotherapy in breast cancer patients: A subanalysis from two phase III trials. Breast. 2017 Jun;33:76-82. doi: 10.1016/j.breast.2017.02.017. Epub 2017 Mar 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aprepitant | Other / unclassified | 80 mg | Oral |
| Comparator | Aprepitant | Other / unclassified | 125 mg | Oral |
| Subject | Netupitant | Small molecule | 300 mg | Oral |
| Comparator | Palonosetron | Other / unclassified | 0.5 mg | Oral |
| Background | Dexamethasone | Small molecule | — | Oral |