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: 15 Feb 2018

At a glance

  • Drugs Paclitaxel (Primary) ; Paclitaxel
  • Indications Advanced breast cancer
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms Oraxol 001
  • Sponsors Athenex
  • Most Recent Events

    • 15 Feb 2018 According to an Athenex media release, the company has already enrolled more than 180 patients and therefore expects the second interim analysis in the third quarter of 2018.
    • 16 Jan 2018 According to an Athenex media release, the United States Food and Drug Administration (FDA) has provided positive feedback on the design of the trial. Specifically, the FDA indicated that if the study meets the primary endpoint with an acceptable Benefit/Risk profile, it could be adequate as a single comparative trial to support registration of Oraxol for a metastatic breast cancer indication in the United States.
    • 12 Jan 2018 Last Checked against ClinicalTrials.gov record.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top