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A multi-country, multicenter, randomized, open-label, parallel group study to assess the efficacy and safety of Docecal compared with Taxotere

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Trial Profile

A multi-country, multicenter, randomized, open-label, parallel group study to assess the efficacy and safety of Docecal compared with Taxotere

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 20 Apr 2023

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At a glance

  • Drugs Docetaxel (Primary)
  • Indications Adenocarcinoma; Advanced breast cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Vivesto

    • Most Recent Events

    • 31 May 2020 Primary endpoint (Overall response rate; partial and complete response) has not been met, according to results presented at the 56th Annual Meeting of the American Society of Clinical Oncology
    • 31 May 2020 Results assessing PK, safety and early activity from two clinical studies: EudraCT2012-005161-12 and EudraCT2013-004889-33 presented at the 56th Annual Meeting of the American Society of Clinical Oncology
    • 12 Sep 2018 According to an Oasmia Pharmaceutical media release, two studies (CTP 293315 and CTP 293313) will form the basis of discussion with other authorities such as EMA for Europe and the FDA for the US.
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