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A Phase 2, Placebo-Controlled, Randomized, Discontinuation Trial of Tivozanib (AV-951) in Patients With Renal Cell Carcinoma

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Trial Profile

A Phase 2, Placebo-Controlled, Randomized, Discontinuation Trial of Tivozanib (AV-951) in Patients With Renal Cell Carcinoma

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 20 Oct 2023

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At a glance

  • Drugs Tivozanib (Primary)
  • Indications Renal cell carcinoma
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors AVEO Oncology

    • Most Recent Events

    • 03 Oct 2023 Results of subgroup analysis determining the efficacy of tivozanib in histologically unclassified/mixed RCC (n= 46) published in the Oncologist.
    • 07 Jun 2022 Results of subgroup analysis of patients with non-clear cell renal cell carcinoma (n=46) presented at the 58th Annual Meeting of the American Society of Clinical Oncology
    • 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.

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