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A Phase III Pivotal Trial of LiPlaCis in Patients with Metastatic Breast Cancer

Trial Profile

A Phase III Pivotal Trial of LiPlaCis in Patients with Metastatic Breast Cancer

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 06 Sep 2021

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At a glance

  • Drugs Cisplatin (Primary)
  • Indications Advanced breast cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Cadila Pharmaceuticals
  • Most Recent Events

    • 30 Aug 2019 According to an Oncology Venture media release, On June 3 company announced that the US FDA had provided its initial response to the IND application and this proposed study.The FDA has requested some additional testing of LiPlaCis related to the product characterization. Company expects to have these additional tests completed in good time before initiation of the study. The study design will be adapted to accommodate FDAs recommendation.
    • 15 Aug 2019 According to an Oncology Venture A/S media release, US Food & Drug administration (FDA) has approved an IDE (Investigational Device Exemption) application for use of the companys drug response predictor LiPlaCis DRP
    • 15 Aug 2019 According to an Oncology Venture A/S media release, the U.S. FDA is evaluating Oncology Venture IND (Investigational New Drug) application for the drug substance LiPlaCis.
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