Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Next Previous
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

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

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.
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Legal
Back to top