A pivotal trial investigating docetaxel emulsion [ANX 514; Adventrx Pharmaceuticals] without corticosteriod premedication, compared with docetaxel [Taxotere; sanofi-aventis] with corticosteroid premedication, in patients with non-small cell lung cancer that has failed prior platinum-based therapy.
Phase of Trial: Phase III
Latest Information Update: 27 Oct 2011
At a glance
- Drugs Docetaxel (Primary)
- Indications Non-small cell lung cancer
- Focus Adverse reactions; Registrational
- 27 Oct 2011 ADVENTRX and the US FDA have met to discuss the trial, and agree that it will provide sufficient clinical data to support approval of the docetaxel emulsion (ANX 514), according to an ADVENTRX media release. The company expects to fline and NDA in 2014.
- 03 Oct 2011 Planned initiation date changed to 1 Jan 2012, according to an ADVENTRX Pharmaceuticals media release.
- 28 Mar 2011 New trial record