A Randomized, Double-Blind, Phase III Study of the Efficacy and Safety of Gemcitabine in Combination With TH-302 Compared With Gemcitabine in Combination With Placebo in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma

Trial Profile

A Randomized, Double-Blind, Phase III Study of the Efficacy and Safety of Gemcitabine in Combination With TH-302 Compared With Gemcitabine in Combination With Placebo in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2017

At a glance

  • Drugs Evofosfamide (Primary) ; Gemcitabine
  • Indications Adenocarcinoma; Pancreatic cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms MAESTRO
  • Sponsors EMD Serono; Merck KGaA; Merck Serono; Threshold Pharmaceuticals
  • Most Recent Events

    • 17 Mar 2017 According to a Threshold Pharmaceuticals media release, the PMDA has just indicated that the current analysis of the this trial data is not sufficient to support the submission of a New Drug Application ("NDA") in Japan, the Company is in ongoing discussions with the PMDA to clarify the scope of an additional study, the results of which may then support the submission of an NDA for evofosfamide in Japan.
    • 07 Nov 2016 According to a Threshold Pharmaceuticals media release, the first meeting has been scheduled with the Japanese PMDA (Pharmaceutical and Medical Devices Agency) to present the improvement in overall survival that was observed in the Japanese sub-population of this trial.
    • 07 Aug 2016 This trial is completed in spain (End date: 04 May 2016).
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