drugset / Trial / NCT02205164
Palonosetron Plus Aprepitant Versus Palonosetron in Preventing Nausea and Vomiting in Leukemic Patients
RandomizedParallel-groupOpen-labelSupportive care
Summary
The aim of present study is to evaluate if the addition of Aprepitant to multiple doses of palonosetron IV enhances the efficacy of multiple doses of palonosetron IV alone, in preventing CINV in AML or High risk MDS patient, treated with multiple days chemotherapy.
Timeline
- Start
- 2011-10
- Primary completion
- 2014-08
- Completion
- 2014-10
Outcome
Missed primary endpoint
paper The primary end point of CR was similar between the treatment arms (72% vs 69%; P = .55) PMID 31725196 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aprepitant | Other / unclassified | 80 mg | Oral |
| Comparator | Palonosetron | Other / unclassified | 0.25 mg | Intravenous |