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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: 01 Jun 2020

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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.
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