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An Open-Label, Randomized, Multicenter, Phase 3 Study to Determine the Safety, Tolerability, and Tumor Response of Oraxol and Its Comparability to IV Taxol or Generic IV Paclitaxel in Subjects With Metastatic Breast Cancer

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Trial Profile

An Open-Label, Randomized, Multicenter, Phase 3 Study to Determine the Safety, Tolerability, and Tumor Response of Oraxol and Its Comparability to IV Taxol or Generic IV Paclitaxel in Subjects With Metastatic Breast Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Jan 2023

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At a glance

  • Drugs Encequidar+paclitaxel (Primary) ; Paclitaxel
  • Indications Advanced breast cancer
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms Oraxol 001
  • Sponsors Athenex

Most Recent Events

  • 03 Jan 2023 According to an Athenex media release, the MHRA application was not rejected based on any clinical efficacy or safety concerns expressed by the MHRA. The company plans to request a review of the MHRA decision by an independent panel board.
  • 03 Jan 2023 According to an Athenex media release, based on data from this trial, the company did not receive regulatory approval from the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) of Oral Paclitaxel formulation for metastatic breast cancer based solely on chemistry, manufacturing and control (CMC) issues.
  • 02 Aug 2022 Status changed from active, no longer recruiting to completed.

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