A Phase IV Study Comparing the Efficacy of Fosaprepitant to Aprepitant for Chemotherapy Induced Nausea and Vomiting in Patients Treated for Gynecological Cancer
Studies have indicated that oral and intravenous anti-emetics are equivalent with regard to
efficacy; when evaluating cost and convenience, the intravenous route may be preferable.
Fosaprepitant, a water-soluble phosphoryl prodrug for aprepitant, is converted to aprepitant
via phosphatases following intravenous administration. Given the rapid conversion of
fosaprepitant to the active form (i.e., aprepitant), the two medications appear to provide a
similarly effective antiemetic impact. Clinical reports have additionally suggested that
fosaprepitant could be appropriate as an intravenous alternative to the oral aprepitant.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Proportion of patients reporting no vomiting during the five days following initiation of chemotherapy
13 months
No
John P Micha, MD
Principal Investigator
Gynecologic Oncology Associates
United States: Institutional Review Board
GOA-NVM1
NCT01432015
September 2011
December 2012
Name | Location |
---|---|
Gynecologic Oncology Associates | Newport Beach, California 92663 |