drugset / Trial / NCT02135510
MEtoclopramide, DExamethasone or Axoli to Prevent or Delay Chemotherapy-induced Nausea and Vomiting in Moderately Emetogenic Non-AC-based Chemotherapy
Phase 3
Completed
249 enrolled
Amsterdam UMC, location VUmc
Noordwest Ziekenhuisgroep · collabRijnstate · collabTergooiziekenhuizen locatie Hilversum · collabZiekenhuis Amstelland · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
In this phase III non-inferiority trial, the aim is to evaluate whether metoclopramide and palonosetron prophylactic antemetic treatment are non-inferior to dexamethasone with regard to its efficacy to prevent delayed chemotherapy-induced nausea and vomiting (CINV) induced by non- anthracyclines plus cyclophosphamide (AC) based moderately emetogenic chemotherapy (MEC).
Timeline
- Start
- 2013-06
- Primary completion
- 2019-03-01
- Completion
- 2019-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dexamethasone | Small molecule | — | — |
| Comparator | Metoclopramide | Small molecule | — | — |
| Comparator | Palonosetron | Other / unclassified | — | — |