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An Open-label, Randomized, Multi-center, Phase III Study to Compare the Safety and Efficacy of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma After Failure of Anti-angiogenic (VEGF-targeted and mTOR Inhibitor) Therapies

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Trial Profile

An Open-label, Randomized, Multi-center, Phase III Study to Compare the Safety and Efficacy of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma After Failure of Anti-angiogenic (VEGF-targeted and mTOR Inhibitor) Therapies

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Feb 2025

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At a glance

  • Drugs Dovitinib (Primary) ; Sorafenib
  • Indications Renal cell carcinoma
  • Focus Registrational; Therapeutic Use
  • Sponsors Novartis

    • Most Recent Events

    • 30 Jan 2025 According to an Allarity Therapeutics media release, company has filed a Form 8-K with the U.S. Securities and Exchange Commission regarding its agreement in principle with the SEC staff to resolve the previously disclosed SEC investigation regarding meetings with the United States Food and Drug Administration concerning New Drug Application for Dovitinib or Dovitinib-DRP, which was submitted to the FDA in 2021.
    • 22 Jul 2024 According to an Allarity Therapeutics media release, the company has received a Wells Notice from the Staff of Securities and Exchange Commission (SEC), which is related to a SEC investigation of the disclosures made by Allarity about the meetings with the USFDA regarding the NDA for Dovitinib or Dovitinib-DRP, submitted in 2021. Allarity will submit a formal response to the SEC.
    • 30 Aug 2023 According to a Allarity Therapeutics release, company announced that the publication of its clinical validation of a novel drug specific DRP-companion diagnostic for dovitinib in the peer-reviewed journal PLOS ONE.

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