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: 25 Oct 2017

At a glance

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

    • 25 Oct 2017 According to a Tesaro media release, the U.S. Food and Drug Administration (FDA) has approved VARUBI (rolapitant) IV in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.
    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top