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
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
- 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.