A Phase 3 International, Multicenter, Double-Blind, Placebo-Controlled, Randomized Trial Evaluating the Efficacy and Safety of Multiple Instillations of Intravesical Apaziquone vs. Placebo in Patients With Low-Intermediate Risk Non-Muscle Invasive Bladder Cancer (NMIBC).
Phase of Trial: Phase III
Latest Information Update: 15 Dec 2016
At a glance
- Drugs Apaziquone (Primary)
- Indications Bladder cancer
- Focus Registrational; Therapeutic Use
- Sponsors Spectrum Pharmaceuticals
- 12 Dec 2016 Status changed from active, no longer recruiting to discontinued.
- 05 May 2016 According to a Spectrum Pharmaceuticals media release, the FDA accepted the NDA for apaziquone and has given Spectrum a PDUFA date of December 11, 2016.
- 13 Mar 2015 According to a Spectrum Pharmaceuticals media release, the company plans NDA submission in 2015.