An Open-Label, Randomized, Pivotal, Bioequivalence Study of Oral and Intravenous Rolapitant

Trial Profile

An Open-Label, Randomized, Pivotal, Bioequivalence Study of Oral and Intravenous Rolapitant

Completed
Phase of Trial: Phase I

Latest Information Update: 11 Jan 2017

At a glance

  • Drugs Rolapitant (Primary) ; Rolapitant (Primary)
  • Indications Chemotherapy-induced nausea and vomiting
  • Focus Pharmacokinetics
  • Sponsors TESARO
  • Most Recent Events

    • 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.
    • 04 Jun 2016 According to a Tesaro media release, the company announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for an intravenous (IV) formulation of rolapitant. The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of January 11, 2017. The NDA for rolapitant IV is supported by data from a clinical program of approximately 350 subjects, and included a bioequivalence study and several other supportive non-clinical
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