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).

Trial Profile

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).

Discontinued
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
  • Most Recent Events

    • 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.
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