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).

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Jun 2017

At a glance

  • Drugs Tivozanib (Primary) ; Sorafenib
  • Indications Renal cell carcinoma
  • Focus Biomarker; Pharmacogenomic; Registrational; Therapeutic Use
  • Acronyms TIVO-1
  • Sponsors AVEO Oncology
  • Most Recent Events

    • 23 Jun 2017 According to an EUSA Pharma media release, European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of FOTIVDA(tivozanib) for the management of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland.
    • 18 May 2017 According to an AVEO Oncology media release, company has completed an oral explanation to the Committee for Medicinal Products for Human Use (CHMP), as part of the Marketing Authorization Application (MAA) review process for tivozanib as a treatment for patients with first-line renal cell carcinoma (RCC).
    • 13 Apr 2017 EUSA Pharma has submitted responses to the EMA Day 180 LOI related to the MAA for tivozanib as a first-line treatment for renal cell carcinoma, according to an Aveo Oncology media release.
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