Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Next Previous
Trial Profile

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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 27 Oct 2017

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

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.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top