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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: 01 Sep 2023

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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 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.
    • 15 Mar 2022 According to a Allarity Therapeutics release, Allarity stated that it intends to seek guidance concerning information, data, and specific deliverables that the agency would require for a resubmitted NDA and PMA to be deemed complete. The Company also stated that it anticipates that a new prospective clinical trial will be required to overcome the FDAs outstanding objections.
    • 15 Mar 2022 According to a Allarity Therapeutics release, the company has requested a Type C meeting with the FDA to discuss potential clinical paths to support approval of dovitinib in view of the regulatory agencys recent Refusal to File letters for the Companys NDA and related PMA, Allarity intends to announce the results of the Type C meeting and its plans for further advancing dovitinib and its DRP-Dovitinib companion diagnostic before end of Q3 2022.
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