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: 20 Nov 2017
At a glance
- Drugs Paclitaxel (Primary) ; Paclitaxel
- Indications Advanced breast cancer
- Focus Adverse reactions; Registrational; Therapeutic Use
- Sponsors Athenex
- 20 Nov 2017 According to an Athenex media release, a second interim analysis is expected in 2018.
- 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.