Trial Profile
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).
Status:
Discontinued
Phase of Trial:
Phase III
Latest Information Update: 07 Nov 2021
Price :
$35
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At a glance
- Drugs Apaziquone (Primary)
- Indications Bladder cancer
- Focus Registrational; Therapeutic Use
- Sponsors Spectrum Pharmaceuticals
- 13 Dec 2017 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.