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: 14 Sep 2017

At a glance

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

    • 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.
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