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?

A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma (TIVO-1)

Trial Profile

A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma (TIVO-1)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Jun 2020

Price : $35 *
  • 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 Tivozanib (Primary) ; Sorafenib
  • Indications Renal cell carcinoma
  • Focus Registrational; Therapeutic Use
  • Acronyms TIVO-1
  • Sponsors AVEO Oncology
  • Most Recent Events

    • 01 Jun 2020 According to an AVEO Oncology media release, the U.S. Food and Drug Administration (FDA) accepted for filing its New Drug Application (NDA) seeking approval for tivozanib. The FDA has assigned the application standard review and a Prescription Drug User Fee Act target action date of March 31, 2021. The FDA also indicated that they do not currently plan on convening an Oncologic Drug Advisory Committee (ODAC) to discuss the application.
    • 31 Mar 2020 According to an AVEO Oncology media release, the company has submitted a New Drug Application (NDA) to the U.S. FDA for tivozanib, as a treatment for relapsed or refractory renal cell carcinoma (RCC). The NDA submission is based on the pivotal active comparator-controlled Phase 3 study (TIVO-3 ).The application is supported by three additional trials (a supportive Phase 3 study: TIVO-1, two Phase 2 studies, Study 902 and Study 201).
    • 04 Nov 2019 According to an AVEO Oncology media release, the FDA found that, in this (TIVO-1) trial the inconsistent progression free survival (PFS) and OS results and imbalance in post study treatments made the trial results uninterpretable and inconclusive when making a risk-benefit assessment necessary for drug approval.
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Back to top