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A Pharmacokinetic Phase I study Comparing Docecal and Taxotere in Patients with Metastatic Breast Cancer

Trial Profile

A Pharmacokinetic Phase I study Comparing Docecal and Taxotere in Patients with Metastatic Breast Cancer

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 20 Apr 2023

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At a glance

  • Drugs Docetaxel (Primary)
  • Indications Advanced breast cancer
  • Focus Pharmacokinetics; Registrational
  • Sponsors Vivesto
  • Most Recent Events

    • 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
    • 24 Jun 2019 According to an Oasmia Pharmaceutical media release, this study indicates that Docecal is bioequivalent with Taxotere (AUC0-last and Cmax) with regards to the total fraction of docetaxel in plasma.
    • 24 Jun 2019 Results from the two clinical studies using Docecal in patients with metastatic breast cancer (CTP 293315 and CTP 293313) presented in an Oasmia Pharmaceutical media release.
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