A Phase 3 International, Double-Bind Trial Evaluating Efficacy and Safety of Multiple Instillations of Intravesical Apaziquone vs. Placebo in Patients With Low-Intermediate Risk Non-Muscle Invasive Bladder Cancer (NMIBC).
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 06 Jun 2017
At a glance
- Drugs Apaziquone (Primary)
- Indications Bladder cancer
- Focus Registrational; Therapeutic Use
- Sponsors Spectrum Pharmaceuticals
- 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.
- 02 Aug 2012 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.