drugset / Trial / NCT00337727
Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)(0869-130)(COMPLETED)
RandomizedParallel-groupDouble-blindPrevention
Summary
The study will test aprepitant for the prevention of CINV in patients receiving their initial cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one cycle of chemotherapy may opt to participate in an optional second cycle during which the patient will receive the same antiemetic regimen as cycle 1, except that an IV formulation of aprepitant will be given in place of the oral formulation on study day one. Study drug administration on subsequent days will be given orally as in cycle 1.
Timeline
- Start
- 2007-01-01
- Primary completion
- 2008-10-28
- Completion
- 2008-11-19
Publications
- Results Rapoport BL, Jordan K, Boice JA, Taylor A, Brown C, Hardwick JS, Carides A, Webb T, Schmoll HJ. Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: a randomized, double-blind study. Support Care Cancer. 2010 Apr;18(4):423-31. doi: 10.1007/s00520-009-0680-9. Epub 2009 Jul 1.
- Rapoport BL. Efficacy of a triple antiemetic regimen with aprepitant for the prevention of chemotherapy-induced nausea and vomiting: effects of gender, age, and region. Curr Med Res Opin. 2014 Sep;30(9):1875-81. doi: 10.1185/03007995.2014.925866. Epub 2014 Jun 12.
- Aapro MS, Schmoll HJ, Jahn F, Carides AD, Webb RT. Review of the efficacy of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in a range of tumor types. Cancer Treat Rev. 2013 Feb;39(1):113-7. doi: 10.1016/j.ctrv.2012.09.002. Epub 2012 Oct 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aprepitant | Other / unclassified | 80 mg | Oral |
| Subject | fosaprepitant dimeglumine | Unknown | 115 mg | Intravenous |
| Background | Dexamethasone | Small molecule | 12 mg | Oral |
| Background | Dexamethasone | Small molecule | 20 mg | Oral |
| Background | Ondansetron | Other / unclassified | 8 mg | Oral |