An Open-Label, Randomized, Pivotal, Bioequivalence Study of Oral and Intravenous Rolapitant
Phase of Trial: Phase I
Latest Information Update: 14 Sep 2017
At a glance
- Drugs Rolapitant (Primary) ; Rolapitant (Primary)
- Indications Chemotherapy-induced nausea and vomiting
- Focus Pharmacokinetics
- Sponsors TESARO
- 14 Sep 2017 Results published in the Journal of Clinical Pharmacology
- 11 Jan 2017 According to a Tesaro media release, the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the rolapitant IV New Drug Application (NDA) for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.
- 23 Jun 2016 Results from this trial were presented at the 2016 MASCC/ISOO Annual Meeting on Supportive Care, according to a Tesaro media release.