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

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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Oct 2017

At a glance

  • Drugs Paclitaxel (Primary) ; Paclitaxel
  • Indications Advanced breast cancer
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Athenex
  • Most Recent Events

    • 05 Oct 2017 Acoording to an Athenex media release, a planned interim analysis of this trial has been conducted and independent Drug Safety Monitoring Board (DSMB) recommended continuation of the study. Second interim analysis at 180 patients is also sheduled in 2018.
    • 14 Aug 2017 According to an Athenex, Inc media release, first interim analysis from this study and feedback from FDA post-interim data on path forward for Oraxol NDA expected in second half of 2017.
    • 14 Aug 2017 According to an Athenex, Inc media release, recruitment of this study is on track for first interim analysis and DSMB meeting in 2017.
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